QA Manager, External Supply Quality Job at Amgen (Singapore)

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

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

Quality Manager, Global Distribution Quality

The Quality Manager, Global Distribution Quality, will serve as a key member of ...

Location

Netherlands , Breda

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Quality and Compliance experience
Master's degree and 6 years of Quality and Compliance experience
Bachelor's degree and 8 years of Quality and Compliance experience
Associate's degree and 10 years of Quality and Compliance experience
High school diploma / GED and 12 years of Quality and Compliance experience

Job Responsibility

Provide quality assurance oversight for Amgen's Global Distribution Hubs, transportation processes, and distribution-related quality systems
Serve as a subject matter expert for Good Distribution Practices, transportation quality requirements, distribution documentation, and applicable procedures
Support the selection, qualification, approval, and ongoing quality oversight of distribution partners, suppliers, third-party service providers, and transportation-related vendors
Provide QA support for distribution deviations, complaints, transportation lane assessments, change controls, and related investigations
Partner with Supply Chain and cross-functional teams to assess and support productivity, transformation, and cost-saving initiatives while maintaining compliance and product quality
Collaborate with Thermal Engineering Systems to implement, qualify, and continuously improve Controlled Temperature Shipping Systems
Support audits and inspections of manufacturing sites, supply hubs, distribution partners, and third-party service providers
Execute internal assessments and audits, develop clear reports, communicate findings, and support timely completion of corrective and preventive actions
Apply risk-based and data-driven decision-making to identify quality risks, evaluate controls, and recommend preventive measures
Represent Quality in cross-functional meetings, quality forums, management reviews, inspection readiness activities, and project teams

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

Quality Manager

The Quality Manager & RP supports the Responsible Person in maintaining complian...

Location

United Kingdom , Kettering

Salary:

Not provided

Healthxchange

Expiration Date

Until further notice

Requirements

Batchelors degree in related field (Quality Assurance, life sciences etc)
Minimum of 3 years’ experience in a QA role in pharma industry (GDP, GMP, GxP)
Experience in GxP QMS management
Previous RP experience on WDA(H) (preferably with the same licence conditions)
Strong analytical, problem-solving and decision-making skills
Effective communication and interpersonal skills
Excellent attention to detail with strong analytical skills
Ability to work independently and collaboratively across multiple cross-functional departments
Preferred knowledge of Lean Six Sigma principles and methodologies
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

Job Responsibility

Support the implementation & maintenance of Healthxchange’s commitment towards GDP, GMP and GPhC Regulatory standards
Provide daily support towards Healthxchange’s operations licences at all sites
namely WDA(H) & MS licenses
Assist the Head of Quality in implementing and maintaining applicable standards across all Healthxchange operations
Act as the Responsible Person
Oversight and maintenance of the Quality Management System (QMS) including document control, change management, deviation and CAPA management, complaint management and validation activities
Assist in the development and improvement of procedures, protocols and departmental documentation
Support customer, supplier qualification and re-qualification
Outsourced activities qualification
Partake and support internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations

What we offer

Company pension
annual performance bonus
25 days holiday plus bank holidays (and increasing with service)
staff discount
staff social events
access to Health Assured EAP

Fulltime

Corporate Quality Manager

Your mission Contribution to the Continuous Improvement of the Corporate Midas ...

Location

China , Shanghai

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Graduation in Science e.g. Chemistry, Pharmacy, Biotechnology is also preferred
Minimum 5 years of working experiences in the Pharmaceutical Industry
Minimum 3 years in Quality Management aspects (e. g. Auditing, Project Management, Production, Validation, QA, QC etc.), auditing experience is preferred
Excellent knowledge of national and international pharmaceutical guidelines (e. g. EU GMP Parts, WHO-Guidelines, ICH-Guidelines, US FDA, cGxP guidelines etc.)
Business/Technical fluent English skills
Experience in working in cross-functional project teams
High social competences, good team worker
Flexibility and ability to work in fast developing environment
Effective Time Management skills

Job Responsibility

Contribution to the Continuous Improvement of the Corporate Midas Pharmaceutical Quality System
Management of international GxP and Regulatory standards during sourcing, development, procurement, manufacturing and supply chain of Drug Substances (IM, API) and Medicinal products (FDF)
Participation and Coordination of Corporate Quality Management activities
QM Compliance Process Responsibilities
e.g. Document management, Change control, Deviation, Complaint, CAPA, Trainings
Communication with the manufacturing and development partner and reviewing, advising and compiling of GxP and regulatory relevant documents
Product Life Cycle Management
Registration, Coordination, Evaluation and follow-up of Changes, Non-conformities which appear in the framework of internal as well as external established processes
Securing the high Midas compliance level with regard to international cGMP regulations (e.g. EU, US, AUS)
Cooperation in inter-divisional, Midas Pharma group-wide and / or cross-company projects

Fulltime

Quality Manager & Responsible Person (RP)

The Quality Manager & RP supports the Responsible Person in maintaining complian...

Location

United Kingdom , Northampton

Salary:

Not provided

Healthxchange

Expiration Date

Until further notice

Requirements

Batchelors degree in related field (Quality Assurance, life sciences etc)
Minimum of 3 years’ experience in a QA role in pharma industry (GDP, GMP, GxP)
Experience in GxP QMS management
Previous RP experience on WDA(H) (preferably with the same licence conditions)
Strong analytical, problem-solving and decision-making skills
Effective communication and interpersonal skills
Excellent attention to detail with strong analytical skills
Ability to work independently and collaboratively across multiple cross-functional departments
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

Job Responsibility

Support the implementation & maintenance of Healthxchange’s commitment towards GDP, GMP and GPhC Regulatory standards
Provide daily support towards Healthxchange’s operations licences at all sites
namely WDA(H) & MS licenses
Assist the Head of Quality in implementing and maintaining applicable standards across all Healthxchange operations
Act as the Responsible Person
Oversight and maintenance of the Quality Management System (QMS) including document control, change management, deviation and CAPA management, complaint management and validation activities
Assist in the development and improvement of procedures, protocols and departmental documentation
Support customer, supplier qualification and re-qualification
Outsourced activities qualification
Partake and support internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations

What we offer

Company pension
annual performance bonus
25 days holiday plus bank holidays (and increasing with service)
staff discount
staff social events
access to Health Assured EAP

Fulltime

Manager, Quality Assurance Operations

Reporting to the Director, Quality Assurance Operations, the Manager, Quality As...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree required, preferably in biomedical sciences, regulatory affairs, clinical research, nursing, or related health sciences
Cell and gene therapy experience required
autologous cell therapy experience strongly preferred
Minimum of 5+ years of relevant experience in Quality Assurance, Quality Operations, Quality Compliance and GMP manufacturing
Minimum of 3 years providing Quality oversight of CDMOs within a GMP manufacturing environment or global pharmaceutical setting
Extensive knowledge of GMP, GCP, ICH guidelines, and FDA biologics regulations
Knowledge of federal research regulations and guidance, including 21 CFR Parts 11, 50, 54, 56, 312, 812
45 CFR 46
ICH GxP guidance
and relevant EU/UK regulations

Job Responsibility

Provide Quality oversight of external partners across the supply chain—including CDMOs and cryopreservation sites—serving as the primary QA point of contact
Lead batch disposition activities to ensure timely, compliant, and right first time product release
Review and approve master batch records, QC test methods, validation protocols/reports, specifications, and associated documentation
Author, review, and revise SOPs and controlled documents as needed
Initiate, review, and approve investigations, root cause analyses, risk assessments, change controls, and CAPAs
Participate as a cross functional team member in process validation, analytical validation, technology transfer, and manufacturing readiness activities
Collaborate with CMC and GxP functional groups to provide QA guidance and support across development and manufacturing operations
Support internal and external audit programs, training initiatives, and inspection readiness activities
Develop, track, and report Quality metrics and KPIs for both internal processes and external partners to drive continuous improvement and ensure accountability
Work independently while fostering strong, collaborative relationships across internal teams and external partners

What we offer

health and retirement, PTO, and stock option plans

Senior Specialist, QA External Manufacturing

The Senior QA Specialist – External Manufacturing is responsible for ensuring qu...

Location

Italy , Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related field
3–5+ years of experience in a GMP Quality Assurance role within the pharmaceutical or CHC industry
Experience in external manufacturing or supplier quality (strongly preferred)
Solid knowledge of EU/FDA GMP regulations, ICH guidelines, and quality management systems
Strong ability to review complex documentation with accuracy and attention to detail
Problem-solving skills with experience in root cause analysis
Excellent communication skills to effectively interface with internal stakeholders and external partners
Ability to manage multiple priorities and work independently with moderate supervision
Familiarity with digital quality tools and AI applications
Proficiency in English

Job Responsibility

Serve as the primary QA contact for assigned CMOs, monitoring performance through quality metrics, documentation review, and regular governance meetings
Support batch review and release activities, ensuring thorough evaluation of manufacturing and packaging records, analytical results, deviations, and associated changes
Review and manage deviations, investigations (including OOS/OOT), and CAPAs, ensuring scientific soundness, robustness, and timely closure
Assess change controls from CMOs, collaborating with cross-functional teams (Regulatory, MS&T, Supply Chain, Procurement) to ensure compliant implementation
Participate in internal audits, CMO audits, and regulatory inspection readiness activities, following up on corrective actions
Maintain and update Quality Agreements to reflect current operations and compliance requirements
Drive continuous improvement initiatives related to quality systems and external manufacturing performance
Support technology transfers, scale-ups, and new product introductions from a QA perspective
Partner with Technical Operations and MS&T to enhance processes and product quality

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Select Country

QA Manager, External Supply Quality

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?