Qa Manager, Drug Substance Job at Life Science Talent (Søborg)

Manager QA - Drug Substance

In this vital role in support to Amgen’s Quality Assurance program, we are seeki...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

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

Fulltime

Qa operations manager

We are looking for a QA Operations Manager to serve as a trusted Quality partner...

Location

Canada , Vancouver

Salary:

105000.00 - 120000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in a relevant scientific discipline
8+ years of GxP industry experience
at least 5 years in a quality management or leadership role within pharmaceuticals, biotechnology, or a comparable regulated environment
strong command of current pharmaceutical regulations and guidances including FDA, Health Canada, EU, and ICH
hands-on experience with biological Drug Substance and aseptic manufacturing processes, including associated testing requirements
comfortable navigating systems such as ERP (SAP), eQMS, and LIMS
communicate with clarity and confidence
self-starter who takes ownership, drives results, and thrives with autonomy in a fast-moving, mission-driven environment

Job Responsibility

Developing and implementing quality systems and oversight programs for Drug Substance (DS) GMP manufacturing, including product changeovers, batch record review, and shop floor surveillance
Partnering with CMC teams as the embedded QA representative, contributing quality expertise and guidance to ensure regulatory and quality requirements are seamlessly integrated across CMC projects
Completing review and approval of GMP documentation - such as batch records, SOPs, logbooks, risk assessments - ensuring full GMP and regulatory alignment and in support of clinical batch disposition
Maintaining inspection readiness of the facility and identifying and escalating risks to members of the site leadership team
Supporting inspections and audits of the clinical manufacturing facility
Participating in end-to-end quality event management, including deviations, investigations, CAPAs, and change controls, collaborating cross-functionally to drive root cause analysis and on-time record closure
Contributing to manufacturing risk assessments, from identification and evaluation through to mitigation, documentation, and reporting
Managing material qualification reviews to support procurement and GMP compliant use of raw materials and components
Acting as a key quality partner across Manufacturing, QC, Supply Chain, F&E, and project management teams, ensuring seamless quality oversight of DS programs
Staying ahead of evolving Quality and Regulatory requirements, proactively assessing their impact on AbCellera and driving timely mitigation strategies to maintain compliance

What we offer

Equity
annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
annual vacation
professional development opportunities
comprehensive health benefits
scientific and technical mentorship is a priority

Fulltime

Senior QA Manager Validation & Quality

This role combines deep expertise in validations (e.g process, cleaning, analyti...

Location

Sweden , Lund

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

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

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

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

Qa Sr Manager External Supply Quality (Esq) - Supplier Quality Management

In this vital role you will serve as the quality lead and subject matter expert ...

Location

United States , Charlotte; Providence; Boston; Los Angeles

Salary:

144021.45 - 194852.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Quality experience OR Associate’s degree and 10 years of Quality experience OR Bachelor’s degree and 8 years of Quality experience OR Master’s degree and 6 years of Quality experience OR Doctorate degree and 2 years of Quality experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Educational background in Life Sciences
Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
Relevant work experience within Drug Substance and Drug Product operations, ideally with single use systems and platforms
5+ years of experience overseeing quality of suppliers
Robust problem-solving and root-cause analysis experience
Strong continuous improvement mentality
Strong compliance, quality, and regulatory knowledge with critical thinking, inquisitive with an end-to-end mentality
Strong communication skills with proficiency in the English language and collaborative cross-functionally behavior

Job Responsibility

Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement
Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO, etc and Amgen’s industry leading expectations
Review and approve quality documentation, including Quality Agreements, deviations, supplier investigations, CAPAs, CAPA EVs, supplier change notifications and change controls, with a sharp eye for risk and compliance
Participate in and/or lead supplier audits and collaborate with internal and external partners to implement corrective and preventive actions
Prepare Amgen sites and suppliers for audits and inspections including development of inspection playbooks
Represent Amgen/ESQ during such audits and inspections - owning our quality story with confidence and clarity
Identify and mitigate risks at the supplier and/or escalate to management
Perform Person in Plant activities, as deemed appropriate
Drive audit commitments to completion
Act as a key quality partner to External Supply, Manufacturing, Supply Chain, Material Sciences, Engineering Technical Authority (ETA), Process Development and other internal functions

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Vice President, Quality

The Vice President, Quality serves a pivotal role in providing quality leadershi...

Location

United States , Verona

Salary:

280000.00 - 340000.00 USD / Year

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

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

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

competitive salaries and an excellent benefit package

Fulltime

Sr. QA Associate I

The Sr. QA Associate I is a Quality Subject Matter Expert whom ensures manufactu...

Location

United States , San Diego

Salary:

36.54 - 41.11 USD / Hour

PCI Pharma Services

Expiration Date

Until further notice

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

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

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

Senior Manufacturing Systems Engineer: Automation - PLC

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

147421.00 - 177467.00 USD / Year

Amgen

Expiration Date

Until further notice

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

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

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Manufacturing Systems Engineer: Automation

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger...

Location

United States , Holly Springs

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Basic Qualifications: High School Diploma / GED and 10 years of Engineering experience OR Associate's Degree and 8 years of Engineering experience OR Bachelor's Degree and 4 years of Engineering experience OR Master's Degree and 2 years of Engineering experience OR Doctorate Degree
Preferred Qualifications: 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 such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software
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 advanced troubleshooting activities, system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies. Experience with DeltaV Live is preferred
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
Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations
Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations
The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making

Job Responsibility

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
Develop detailed specification and engineering policies and procedures that affect multiple organizational units
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment

What we offer

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

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Qa Manager, Drug Substance

Job Description

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