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

Quality Assurance Senior Manager, External Supply Quality

Quality Assurance Senior Manager (External Supply Quality) at Amgen Singapore Ma...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Quality and Compliance experience OR Master’s degree and 6 years of Quality and Compliance experience OR Bachelor’s degree and/or 8 years of Quality and Compliance experience
Strong background in GMP compliance, with a focus on external manufacturing or materials management
Significant Quality and/or Manufacturing experience at commercial manufacturing facilities
Confident communicator who can build relationships across technical and cultural boundaries
Track record of driving change, improving systems, and mentoring others within Quality
Skilled in using risk based decision-making approaches
Experience with regulatory activities and variation management
Proven ability to lead audits, manage complex investigations, and influence quality improvements
Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing)

Job Responsibility

Act as the quality lead for supplier relationships, ensuring performance through robust monitoring, technical site visits, and continuous improvement
Drive proactive quality management of suppliers, ensuring compliance with global GMP standards and Amgen’s high expectations
Provide quality oversight of new product introductions, tech transfers, and process qualification activities at the contract manufacturing site
Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls, with a sharp eye for risk and compliance
Perform tactical batch disposition activities in support of lot release
Negotiate Quality Agreement terms and conditions and ensure adherence
Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions
Take the lead in cross-functional initiatives and continuous improvement projects to improve regional operations and daily tasks
Ensure inspection readiness for our contract manufacturing sites and internal Amgen records
Support management of audit/inspection commitments to completion

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

QA Manager, External Supply Quality

In this position, you’ll lead quality oversight for Amgen Contract Manufacturing...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience in Quality and/or Manufacturing experience at small and/or large molecule drug substance or drug product manufacturing facilities
Technical experience with synthetics/small molecules a strong plus
Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing)
Confident communicator who can build relationships across technical and cultural boundaries
Track record of driving change, improving systems, and mentoring/coaching others
Skilled in using risk based decision-making approaches
Experience with regulatory activities and variation management

Job Responsibility

Lead quality oversight for Amgen Contract Manufacturing locations in the JAPAC region
Drive proactive quality management of suppliers, ensuring compliance with global GMP standards and Amgen's high expectations
Act as the quality lead for supplier relationships, ensuring performance through robust monitoring, technical site visits, and continuous improvement
Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls
Provide quality oversight and approval steps for new product introductions, tech transfers, analytical and method qualifications and validations, and process qualification activities at the contract manufacturing site
Perform tactical batch disposition activities in support of lot release
Negotiate Quality Agreement terms and conditions and ensure adherence
Perform supplier audits for key manufacturers within the JAPAC region
Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions
Take the lead in cross-functional initiatives and continuous improvement projects

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Sr. Food Safety & Quality Assurance Manager

We are seeking a highly specialized, results-driven Sr. Food Safety & Quality As...

Location

United States

Salary:

90000.00 - 140000.00 USD / Year

American Food & Vending

Expiration Date

Until further notice

Requirements

Bachelor's degree in food science, Public Health, Environmental Health, or a related field
Advanced degree and/or professional certifications preferred
Experience within the dining and refreshment sector (casual dining, quick-service, catering, events, or hospitality)
Lead Auditor certifications (ISO 22000, HACCP, SQF) or extensive internal auditing experience
Strong supplier quality management and vendor qualification experience
Knowledge of sanitation validation, environmental monitoring, and comprehensive allergen control programs
Familiarity with ERP systems and QA data integration beyond Salesforce
Experience supporting complex supply chains, international operations, or multi-brand portfolios
Demonstrated, hands-on experience with FDA, HACCP, SQF, DOT, NFPA, OSHA, and GMP requirements
Proven ability to interpret regulations and apply them to complex, multi-site operations

Job Responsibility

Design, implement, and maintain comprehensive food safety and quality assurance programs across multi-site dining and refreshment operations
Ensure compliance with applicable regulations and standards, including FDA (FSMA, GMPs, recalls, labeling), HACCP, SQF, DOT, NFPA, OSHA, and GMPs
Lead the development, validation, and optimization of HACCP plans, prerequisite programs (PRPs), sanitation programs, allergen control plans, and environmental monitoring programs where applicable
Maintain robust documentation control, versioning, and recordkeeping systems to support FDA, SQF, and GMP compliance, including change control and regulatory reviews
Conduct internal audits, supplier audits, third-party assessments, and mock recalls
Lead regulatory due diligence, risk assessments, gap analyses, CAPA development, remediation activities, and effectiveness verification through revalidation and follow-up audits
Oversee recall readiness, crisis management protocols, mock recalls, and business continuity planning
Monitor evolving regulatory requirements (FDA, OSHA, DOT, NFPA) and translate updates into actionable program enhancements
Lead food safety and occupational safety incident investigations, including root-cause analysis, containment, corrective and preventive actions, and verification activities
Promote a proactive food safety and workplace safety culture through continuous improvement initiatives and cross-functional engagement

What we offer

Weekly Pay
401K with match
Employee Assistance Program
Eligible employees offered Medical, Prescription, Dental, and Vision Plans
Learning and advancement opportunities

Fulltime

Quality Assurance Manager – Continuous Improvement

The Quality Assurance Manager – Continuous Improvement drives quality excellence...

Location

United States of America , Manchester OR Taftville

Salary:

95000.00 - 120000.00 USD / Year

Bob's Discount Furniture Home

Expiration Date

Until further notice

Requirements

Bachelor’s degree in quality assurance, Engineering, or related field
5+ years of experience in Quality Assurance, including 2+ years in a leadership or managerial role
Demonstrated experience leading continuous improvement initiatives
Working knowledge of regulatory standards and quality systems (e.g., ISO 9001)
Ability to sit, stand, walk, bend, reach, and move throughout office, store, and distribution center environments
Ability to handle and move items up to 50 lbs. (up to 100 lbs. with or without reasonable accommodation)

Job Responsibility

Develop and maintain quality standards, policies, and procedures to meet internal and regulatory requirements
Oversee inspection and testing processes for raw materials, components, and finished goods
Partner with product development, sourcing, and vendors to ensure quality standards are met
Lead Lean, Six Sigma, and Kaizen initiatives to reduce defects and improve efficiency
Analyze quality data, establish KPIs, and implement corrective actions
Facilitate cross-functional workshops to eliminate waste and optimize workflows
Conduct internal and external quality audits
Investigate customer complaints and quality issues, identifying root causes and preventive solutions
Partner with sourcing, logistics, compliance, merchandising, and suppliers to align quality objectives
Lead Quarterly Quality Reviews with vendors and provide performance feedback

What we offer

Competitive medical, dental, and vision insurance
Generous PTO, including holidays and your birthday
401(k) with company match
Tuition reimbursement and professional development opportunities
Employee discount starting Day 1

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 Food Safety and Quality Assurance Manager

We are seeking a highly specialized, results-driven Senior Food Safety & Quality...

Location

United States

Salary:

90000.00 - 140000.00 USD / Year

American Food & Vending

Expiration Date

Until further notice

Requirements

Bachelor’s degree in food science, Public Health, Environmental Health, or a related field
Advanced degree and/or professional certifications preferred
Experience within the dining and refreshment sector (casual dining, quick-service, catering, events, or hospitality)
Lead Auditor certifications (ISO 22000, HACCP, SQF) or extensive internal auditing experience
Strong supplier quality management and vendor qualification experience
Knowledge of sanitation validation, environmental monitoring, and comprehensive allergen control programs
Familiarity with ERP systems and QA data integration beyond Salesforce
Experience supporting complex supply chains, international operations, or multi-brand portfolios
Demonstrated, hands-on experience with FDA, HACCP, SQF, DOT, NFPA, OSHA, and GMP requirements
Proven ability to interpret regulations and apply them to complex, multi-site operations

Job Responsibility

Design, implement, and maintain comprehensive food safety and quality assurance programs across multi-site dining and refreshment operations
Ensure compliance with applicable regulations and standards, including FDA (FSMA, GMPs, recalls, labeling), HACCP, SQF, DOT, NFPA, OSHA, and GMPs
Lead the development, validation, and optimization of HACCP plans, prerequisite programs (PRPs), sanitation programs, allergen control plans, and environmental monitoring programs where applicable
Maintain robust documentation control, versioning, and recordkeeping systems to support FDA, SQF, and GMP compliance, including change control and regulatory reviews
Conduct internal audits, supplier audits, third-party assessments, and mock recalls
Lead regulatory due diligence, risk assessments, gap analyses, CAPA development, remediation activities, and effectiveness verification through revalidation and follow-up audits
Oversee recall readiness, crisis management protocols, mock recalls, and business continuity planning
Monitor evolving regulatory requirements (FDA, OSHA, DOT, NFPA) and translate updates into actionable program enhancements
Lead food safety and occupational safety incident investigations, including root-cause analysis, containment, corrective and preventive actions, and verification activities
Promote a proactive food safety and workplace safety culture through continuous improvement initiatives and cross-functional engagement

What we offer

Weekly Pay
401K with match
Employee Assistance Program
Eligible employees offered Medical, Prescription, Dental, and Vision Plans
Learning and advancement opportunities

Fulltime

Specialist, Supply Chain Quality Assurance

Alfasigma is a privately held global healthcare company founded over 75 years ag...

Location

Italy , Milano

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

3–5+ years in Quality Assurance or Supply Chain QA within pharmaceutical industry
Strong experience with GDP compliance, ideally in Italy
Degree in Pharmacy, Life sciences
Good knowledge of specific EU GDP guidelines
Italian pharmaceutical distribution requirements (AIFA)
Cold chain and temperature monitoring systems
Experience with eQMS tools (deviations, CAPA, audits)
Familiarity with serialization/FMD systems is a plus
Excellent communication skills in Italian and English
Ability to work cross-functionally and manage stakeholders

Job Responsibility

Ensure full compliance with EU GDP guidelines (2013/C 343/01) and Italian AIFA requirements
Support the maintenance and improvement of the Global Quality Management System (QMS) related to distribution activities
Manage SOPs, deviations, CAPAs, change controls, and quality risk assessments
Support preparation and management of internal/external audits and inspections (AIFA, EMA, clients)
Oversee QA aspects of warehousing, transport, and distribution activities
Ensure qualification and monitoring of logistic service providers (LSPs) and distributors in Italy
Manage temperature-controlled logistics, including cold chain compliance
Review and approve shipment documentation, deviations, and complaints related to distribution
Qualify and audit 3PL providers, wholesalers, and transport partners in the Italian market
Ensure technical agreements (Quality Agreements) are in place and up-to-date

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

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

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Quality Assurance Manager, External Supply Quality

Job Description

Job Responsibility

Requirements

What we offer

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