CrawlJobs Logo

Manager QA - Drug Substance

amgen.com Logo

Amgen

Location Icon

Location:
United States , Juncos

Category Icon
Category:
Quality Control

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

In this vital role in support to Amgen’s Quality Assurance program, we are seeking a highly motivated and proactive leader to join us as Manager QA, to lead and oversee the activities of the plant Quality Assurance department in our multi-product mammalian cell culture facility located in Juncos, Puerto Rico in a non-standard shift operation (night shift).

Job Responsibility:

  • Lead the Quality team for assigned plant(s) or functional area(s), overseeing staffing, training, supervision, and performance management
  • Ensure products are manufactured, tested, stored, and distributed in compliance with cGMP, GDP, and applicable regulations
  • Maintain compliance of facilities, equipment, materials, processes, procedures, and products with cGMP and regulatory standards
  • Review, approve, and track cGMP documentation, including NCs, CAPAs, Change Controls, validations, and assays
  • Approve Master Production Records (MPs), process validation protocols and reports, Environmental Characterization reports, and planned incidents
  • Represent QA in New Product Introduction (NPI) teams and during audits and inspections
  • Lead investigations and plant audits
  • approve change-over completion activities
  • Ensure deviations are properly investigated and documented
  • verify accuracy and completeness of production records and test results
  • Collaborate cross-functionally to ensure QMS processes follow established procedures
  • Bring up quality, compliance, supply, and safety risks to senior management
  • Ensure controlled documents have assigned owners and that periodic reviews are completed on time

Requirements:

  • Doctorate degree
  • Or Master’s degree and 3 years of experience in regulated industry experience
  • Or Bachelor’s degree and 5 years of experience in regulated industry experience
  • Or Associate’s degree and 10 years of experience in regulated industry experience
  • Or High school diploma / GED and 12 years of experience in regulated industry experience
  • Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
  • Managerial experience may run concurrently with the required technical experience

Nice to have:

  • Educational background in Life Sciences or Engineering
  • Experience with processes involved with Quality Assurance, manufacturing and distribution, Quality Control, validation, and process development
  • Validated expertise in Quality Systems such as Deviations, CAPA and Change Control
  • Experience leading cross functional teams with the influencing and negotiating skills
  • Strong organizational, project management and change management skills
  • Strong communication skills (both written and oral), and comprehend in English and Spanish
  • Ability to provide direction and establish goals for individual staff members and work groups, empower staff, manage and distribute workloads
  • Ability to interact with regulatory agencies
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and an annual site shutdown
  • Flexible work models, including remote work arrangements, where possible

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Amgen - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Manager QA - Drug Substance

Specialist QA - Drug Substance Ops

In this vital role you will oversight on-the-floor operations, you will be respo...
Location
Location
United States , Juncos
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree
  • or Master’s degree and 2 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
  • or Bachelor’s degree and 4 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
  • or Associate's degree and 8 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
  • or High school diploma / GED and 10 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
Job Responsibility
Job Responsibility
  • Execute Quality disposition (approval or rejection) of bulk drug substances
  • Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations
  • Ensure that deviations from established procedures are identified, reported, and documented per procedures
  • Ensure that changes that could potentially impact drug substance quality are assessed according to procedures
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
  • Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations
  • Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress
  • Ensure completion of required training and maintain assigned training adherence to support successful task execution
  • Collaborate and partner cross‑functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures
  • Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
  • A discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans and an annual site shutdown
  • Fulltime
Read More
Arrow Right

Senior QA Manager Validation & Quality

This role combines deep expertise in validations (e.g process, cleaning, analyti...
Location
Location
Sweden , Lund
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree (Ph.D. or M.S.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline
  • 15+ years of relevant biopharmaceutical industry experience, including significant roles in QA process development, manufacturing and validation
  • Strong knowledge and experience of biotech and aseptic manufacturing incl testing
  • Deep understanding of regulatory requirements (FDA, EMA, ICH) related to development, manufacturing and validation
  • Strong experience managing external partners and CDMOs/CMOs
  • Strong experience of Authority inspections as presenter, coordinator (FDA, EMA and other markets)
  • Proven track record of leading validation activities for drug substance and drug product development, scale-up, and manufacturing for clinical and commercial stages
  • Strong communication, and interpersonal skills with the ability to influence across functions and levels
  • Strong problem-solving skills and a hands-on, execution-oriented mindset
Job Responsibility
Job Responsibility
  • Provide strategic and operational direction for quality expectation including validation within drug substance and drug product process development, scale-up, technology transfer, and manufacturing activities
  • Oversee development and implementation of quality and validation processes to ensure compliant, robust and cost-effective manufacturing processes for development, clinical and commercial supply
  • Manage external manufacturing partners (CDMOs/CMOs), ensuring alignment with quality expectations and program objectives
  • Support authority inspection and internal Hansa/external audits of suppliers and vendors
  • QA review and approval of validation documentation
  • Partner cross-functionally with CMC, Regulatory, Clinical, Supply Chain
  • Establish and maintain strong relationships with internal and external stakeholders to ensure seamless execution of QA strategies and operational tasks
  • Drive continuous improvement initiatives such as -evaluate and update the Quality Management System (QMS), proactively identify areas for improvement
What we offer
What we offer
  • A position in a company that envisions life changing outcomes for patients with acute or serious immune mediated conditions
  • The chance to be part of an innovative R&D-driven organisation with a strong desire to make a difference for people
  • An opportunity to build a fully integrated biopharmaceutical company with global outreach
  • An open-minded and welcoming atmosphere
  • Friendly, motivated and skilled colleagues with whom you can both laugh and work
  • Fulltime
Read More
Arrow Right

Vice President, Quality

The Vice President, Quality serves a pivotal role in providing quality leadershi...
Location
Location
United States , Verona
Salary
Salary:
280000.00 - 340000.00 USD / Year
arrowheadpharma.com Logo
Arrowhead Pharmaceuticals, Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS in Life Sciences or related discipline
  • 15+ years in QA or compliance with particular experience in cGMP commercial manufacturing environment and with experience in GCP clinical programs for drugs and/or biologics preferred
  • 10+ years in a previous management role
  • Experience with developing a QMS and hosting successful regulatory agency inspections
  • Ability to thrive in a fast-paced environment, with experience in sponsor quality oversight responsibilities for contract vendors across all GxP areas
  • Implementation of internal phase appropriate GMP drug substance manufacturing & testing systems
  • Prior successful management of a Quality Management System for commercial product
  • Drug development through commercial manufacturing compliance experience
  • Excellent oral and written communication skills required
  • Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint)
Job Responsibility
Job Responsibility
  • Develop and facilitate Quality Systems as delineated in the Quality Manual to support Arrowhead’s clinical development pipeline and preparations for product commercialization
  • Implement and maintain an overall Quality Management System (QMS) meeting the requirements of activities conducted within Arrowhead
  • Develop and oversee the internal Quality Control (QC) lab department and operations
  • Support activities relating to clinical QA GCP regulations at the Pasadena location
  • Ensure systems are in place for conducting and tracking employee training required by GxP regulations
  • Support efforts pertaining to internal design, construction, commissioning, and qualification of GMP facilities
  • Review and approve outsourced contract manufacturing documentation such as validation protocols and reports
  • master batch records
  • deviations
  • analytical methods and methods validation
What we offer
What we offer
  • competitive salaries and an excellent benefit package
  • Fulltime
Read More
Arrow Right

Director, Analytical Development and Quality Control

The Director, Analytical Development and Quality Control will oversee quality co...
Location
Location
United States , Waltham
Salary
Salary:
175000.00 - 230000.00 USD / Year
kailera.com Logo
Kailera Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree and 10+ years of experience, or 8+ with advanced degree, in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
  • Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, and dissolution
  • Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
  • Hands-on experience managing QC activities performed at CDMOs and third-party testing sites, with an emphasis on release and stability testing
  • Experience with stability-trending software
  • Proven experience supporting OOS/OOT investigations, deviations, CAPAs, and change controls
  • Strong track record of working with CROs/CMOs and managing external QC activities
  • Demonstrated leadership ability with experience mentoring and developing staff
  • Strong communication, cross-functional collaboration, and project-management skills
  • Innovative team-player with high energy for our dynamic company environment
Job Responsibility
Job Responsibility
  • Develop phase-appropriate QC strategies, procedures (SOPs), and workflows to support QC operations within the CMC team supporting clinical programs from early development through commercialization
  • Design, implement, and manage stability programs for drug substances and drug products, including protocol development, execution, trending, and reporting
  • Utilize stability trending and statistical analysis software (e.g., JMP, SLIMStat) to monitor product performance and predict shelf-life
  • Oversee QC activities at CDMOs and third-party testing sites, ensuring cGMP compliance, data integrity, and timely release and stability testing
  • Establish robust data management practices for QC, including electronic systems for data capture, trending, and archival, to support regulatory submissions
  • Ensure QC activities align with integrated development timelines and global regulatory expectations (ICH, USP, EP, JP)
  • Provide QC support for investigations (OOS/OOT), deviations, CAPAs, and change controls
  • Prepare for audits and inspections, representing QC to regulatory authorities
  • Collaborate cross-functionally with CMC, QA, and Regulatory teams to ensure accurate QC documentation (SOPs, CoAs, protocols, reports)
  • Strong, demonstrated ability to work effectively in teams and collaborate cross-functionally
What we offer
What we offer
  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • a year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • Fulltime
Read More
Arrow Right
New

Senior Manufacturing Systems Engineer: Automation - PLC

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
Location
Location
United States , Holly Springs
Salary
Salary:
147421.00 - 177467.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma / GED and 10 years of Engineering experience
  • Associate’s Degree and 8 years of Engineering experience
  • Bachelor’s Degree and 4 years of Engineering experience
  • Master’s Degree and 2 years of Engineering experience
  • Doctorate Degree
  • Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering
  • Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation
  • Extensive understanding and background in programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies
  • Experience with Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
  • Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95
Job Responsibility
Job Responsibility
  • Provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations
  • Work hand in hand with the capital project team to deliver robust automation systems to operate the new plant utility and standalone systems
  • Develop and maintain automation solutions utilizing various PLC's such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system
  • Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLC’s and interface hardware
  • Lead and support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including power distribution, grounding requirements, I/O assignments, etc
  • Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
  • Lead in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems
  • Collaborate with business partners to understand how standalone systems can improve workflow and productivity. Synthesize requirements from clients, customers, or end-users to develop the best automation solutions
  • Provide clear documentation for delivered solutions and processes
  • work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Manufacturing Systems Engineer: Automation - PLC

As a Manufacturing Systems Engineer, you will work with a group of automation en...
Location
Location
United States , Holly Springs
Salary
Salary:
118497.00 - 134250.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma / GED and 8 years of Engineering experience
  • Associate’s Degree and 6 years of Engineering experience
  • Bachelor’s Degree and 2 years of Engineering experience
  • Master’s Degree
  • Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering
  • Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation
  • Extensive understanding and background in programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies
  • Experience with Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
  • Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95
  • Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution
Job Responsibility
Job Responsibility
  • Develop and maintain automation solutions using various PLC's such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system
  • Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLC’s and interface hardware
  • Support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including power distribution, grounding requirements, I/O assignments, etc.
  • Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
  • Assist in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems
  • Collaborate with business partners to understand how standalone systems can improve workflow and productivity. Synthesize requirements from clients, customers, or end-users to develop the best automation solutions
  • Provide clear documentation for delivered solutions and processes
  • work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards
  • Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units
  • Support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right
New

Senior Manufacturing Systems Engineer: Automation

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
Location
Location
United States , Holly Springs
Salary
Salary:
147421.00 - 177467.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma / GED and 10 years of Engineering experience
  • Associate’s Degree and 8 years of Engineering experience
  • Bachelor’s Degree and 4 years of Engineering experience
  • Master’s Degree and 2 years of Engineering experience
  • Doctorate Degree
  • Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
  • Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation
  • Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies
  • Experience with Emerson DeltaV DCS system, Process Control Network design including network segregation, virtual infrastructure design and implementation, and ability to perform sophisticated troubleshooting activities, system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
  • Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95
Job Responsibility
Job Responsibility
  • Provide automation technical leadership to a group of automation engineers
  • Work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant
  • Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS)
  • Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
  • Collaborate with business partners to understand how automation can improve workflow and productivity
  • Synthesize requirements from clients, customers or end-users to develop the best automation solutions
  • Provide clear documentation for delivered solutions and processes
  • work closely with QA partners while supporting computerized systems validation processes in a GxP environment
  • Maintain Data Integrity Assessments with the current Amgen and Industry standards
  • Build the business processes to support the project scope in alignment with project timelines
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
  • Fulltime
Read More
Arrow Right

Senior Director Quality Assurance

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States , West Greenwich
Salary
Salary:
218358.00 - 252850.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
  • Master’s degree and 8 years of Quality/Manufacturing/Engineering experience
  • Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience
  • At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Job Responsibility
Job Responsibility
  • Lead Plant QA team providing Quality Oversight of 24/7 continuous manufacturing operation and high impact strategic decision making in two (2) multi-product Drug Substance facilities
  • Scope includes on-the-floor support for AR5 Fed batch and AR30 MoF, I-530, Buffer Preparation Area, Media Preparation, Component Preparation Area, In Process Testing Lab, record review, quality oversight of deviation investigations and changes, document approval, and disposition
  • Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and other applicable regulations and specifications
  • Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
  • Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
  • Provide quality input and partner with cross-site and cross-functional area leads to advance Amgen’s manufacturing strategy
  • Develop strategies in support of regulatory inspections and site audits
  • Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties
  • Develop area budget, manage expenditure and identify productivity improvement opportunities
  • Represent ARI Quality in cross-function and cross-site forums
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy