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

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

Sr. QA Associate I

The Sr. QA Associate I is a Quality Subject Matter Expert whom ensures manufactu...
Location
Location
United States , San Diego
Salary
Salary:
36.54 - 41.11 USD / Hour
pci.com Logo
PCI Pharma Services
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent required
  • Bachelor’s degree preferred in a Life Sciences discipline or equivalent relevant experience required
  • Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent
  • Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity
  • Knowledge of Fill Finish and Biologics production environments preferred
  • Familiarity working with electronic batch records
  • Detail oriented and strong interpersonal and verbal communication skills
Job Responsibility
Job Responsibility
  • Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
  • Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices
  • Independently performs quality operations within multiple manufacturing departments
  • Participates in multiple process improvement projects
  • Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and tech transfer forms
  • Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product. Represents QA for high profile clients
  • Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)
  • Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
  • Supports the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes
  • Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
What we offer
What we offer
  • eligibility for an annual performance bonus
  • paid time off
  • health insurance coverage (including dental and vision)
  • a flexible spending account
  • a 401(k) plan
  • Fulltime
Read More
Arrow Right

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

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

QA Specialist II - Operations

The QA Operations Specialist II – Floor Support is responsible for providing QA ...
Location
Location
United States , Bedford
Salary
Salary:
Not provided
pci.com Logo
PCI Pharma Services
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a relevant scientific field
  • Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality, or Equivalent combination of education and experience
  • ASQ certification is a plus
  • Exposure to RCA, technical writing, and working with quality related investigations
  • Exposure to lean operation excellence highly desirable
  • Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
  • Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
  • Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Job Responsibility
Job Responsibility
  • Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues that occur during manufacturing
  • Consult with internal teams such as Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems
  • Perform frequent walkthroughs and internal audits of manufacturing and support areas to ensure adherence to policies and procedures
  • Batch record review for adherence to internal procedures and Good Documentation Practices
  • Support the evaluation and disposition of intermediates, finish bulk drug substance and drug product
  • Review, approval and disposition of incoming materials such as consumables, excipients, and Active Pharmaceutical Ingredient
  • QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications
  • Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions
  • Co-ownership of nonconforming material investigations
  • Review of Quality Control environmental and utility monitoring data and test results
  • 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
Remote jobs 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 Salaries About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy