GCP Quality Compliance Manager Job at Amgen (Cambridge)

Quality Compliance Manager

In this vital role you will report to the Japan Asia Pacific (JAPAC) Quality Com...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards
2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or TrackWise
Thorough understanding of Clinical R&D activities and Global/local Regulations
Good knowledge of Regulatory Submission and overall Inspection Management procedures expected by Japan Pharmaceuticals and Medical Devices Agency (PMDA)
Experience in supporting regulatory inspections by overseas authorities (e.g. FDA, EMA), at Sponsor, CRO, or investigator‑site level is preferred
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format

Job Responsibility

Review specific clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
Provide quality oversight and assess the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
Provide oversight for the development and implementation of Quality Plans specifically suited within Japan
Establish country level expertise to ensure quality and compliance to local regulations and international guidelines (e.g.: ICH GCP, WHO etc.)
Liaise with the Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g.: biomarker usage and imaging methods)
Collaborate on TA and Affiliate-specific Quality Assurance plans for application within the region
Support local Clinical Trial and global/local cross-functional teams for all quality management activities, including Issue Management, Risk Assessment, Inspection Readiness activities, Audits and Inspection Management activities
Prepare, analyze and communicate compliance metrics/trends on a periodic basis to key stakeholders and senior leaderships
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods)

Fulltime

R&D Clinical - Quality Compliance Senior Manager

We are hiring a R&D Clinical Quality Compliance Senior Manager, who will operate...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s Degree in appropriate discipline e.g. Life Sciences, Medical
15-18 years’ experience working in Biotech, Pharmaceutical or CRO company
In-depth knowledge of ICH GCP
Extensive experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are core responsibilities
Experience using electronic QMS such as Veeva Vault and eTMF
Experience and understanding of Clinical R&D activities and Global Regulations
In-depth knowledge of the Regulatory Submission and Inspection readiness, preparation and management procedures
Extensive experience in Quality Oversight of Clinical Trials, including clinical trial protocol development and execution
Strong verbal and written communication skills, including strong business writing abilities and active listening
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Key advisor to the study team throughout the clinical trial life cycle, providing independent and objective quality input in the areas of GCP and compliance with Amgen SOPs and processes
Review and provide input into the development of the initial clinical study protocol and subsequent amendments, with focus on quality by design, confirming it’s fit for purpose, clear, concise and consistent
Actively provide input into study risk assessment activities
Review and provide input into other key study documents and plans
Direct study teams through the management of complex quality issues
Participate in key activities related to Risk Based Quality Management
Using available tools, analyze quality data metrics
Monthly meetings with study team lead/associate director, to review the following: on-going quality issues, quality trends, program filing timelines, inspection readiness, potential inspections and audit scheduling and planning and any other topics deemed relevant
Support the clinical study team with inspection readiness activities
Support continuous improvement initiatives within TA Quality

What we offer

Varied 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

Glp/gcp quality compliance auditor

We are seeking an experienced member to join our Quality Assurance team. The Com...

Location

United States of America , Indianapolis

Salary:

Not provided

Labcorp

Expiration Date

Until further notice

Requirements

Bachelor's degree in a Pharmacy, Chemistry or Biology related discipline
Postgraduate degree (MSG or equivalent) in science or management related discipline, preferable
10 years’ experience may be substituted for education
8 years in regulatory environment (experience in GLP/GCP roles)
4 years Laboratory / Quality background specifically with ISO 15189/ISO 13485 standards
Strong written and verbal communication skills
Excellent organizational and project management abilities
Strong negotiation, influencing and networking skills
Demonstrative skills include risk management application experience including risk-based auditing methodologies
Experience in training and developing internal auditors

Job Responsibility

Managing the Internal Audit Program: Plan and implement the internal audit program
Schedule and oversee the approved audit program
Develop and clarify audit scopes to ensure comprehensive assessments
Approve and assign internal audits to appropriate team members
Preparedness and Oversight: Ensure appropriate stakeholder engagement throughout the audit process
Facilitate effective planning and communication with all relevant parties
Audit Hosting & Regulatory Support: Serve as the primary host for internal audits
Provide regulatory inspection support and host sponsor audits as required
Severity Finding and Audit Report Review with Management: Document audit findings and develop detailed reports with actionable recommendations
Collaborate with stakeholders to implement CAPAs and monitor their effectiveness

What we offer

Medical
Dental
Vision
Life
STD/LTD
401(k)
Paid Time Off (PTO) or Flexible Time Off (FTO)
Tuition Reimbursement
Employee Stock Purchase Plan

Fulltime

Qa Gcp Manager

Proclinical is looking for a Quality Assurance Manager to join a dynamic organiz...

Location

United Kingdom , City of London

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Training and proven years of working experience in Good Clinical Practice (GCP)
Professional working years of relevant QA experience, preferably within the life sciences sector
Expert knowledge of UK, EU, and US clinical trial legislation
Strong ability to communicate effectively and influence across and within the organization
Excellent written and verbal communication skills
Exceptional interpersonal and negotiation skills

Job Responsibility

Manage the Quality Management System (QMS)
Contribute to the generation and management of the internal audit schedule
Independently conduct and report audits in accordance with the internal audit schedule
Conduct vendor audits as instructed
Lead, manage, and coordinate client audits and regulatory inspections
Respond to and follow up on audit reports and vendor questionnaires
Review and provide QA approval of SOPs and other controlled documents
Effectively monitor compliance with processes
Provide input for and maintain oversight of CAPAs and quality issues
Generate quality metrics reports to update the management team on quality-related issues and initiatives

What we offer

Flexible home and/or office working
Industry leading training
Competitive total reward package

Fulltime

Clinical Quality Manager

We are looking for a highly motivated Clinical Quality Manager that is excited t...

Location

Canada , Montréal; Vancouver

Salary:

126400.00 - 158000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

8+ years of relevant work experience
3+ years in a Clinical Quality role
proven expertise in quality control, trainings, metrics, and process improvement
experience within clinical operations would be an asset
able to travel up to 20%
Bachelor’s or post-secondary degree in Pharmaceutical Science or related field
expertise in ICH-GCP guidelines and regulations
outstanding team player and communicator
bilingualism in French and English is strongly preferred

Job Responsibility

Writing and reviewing SOPs and procedures in support of Phase 1-3 clinical trial activities
Assessing the impact of new or updated ICH or local guidelines on current clinical trial activities worldwide
Performing qualifications of service providers for clinical trials and preclinical activities
Ensuring GCP inspection readiness and preparing and assisting in the conduct of Health Authority inspections
Overseeing CAPA to ensure timely resolution, identifying process improvements opportunities, and developing quality control plan for site quality control visits
Executing risk-based Quality Control (QC) oversight of internal operations
Performing regular QC of internal processes and study specific materials
Supporting internal project teams with understanding and interpreting ICH-GCP, regulations, SOPs, and local processes, and proactively identifying training gaps
Maintaining and delivering training curricula and training compliance for internal and external stakeholders
Providing insight on the feasibility and implementation of patient centric initiatives

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

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

Clinical Quality Manager

Ensure implementation and oversight of the GCP Quality Management System (QMS) f...

Location

China , Shanghai

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Advanced scientific/technical degree preferred (MS/MD/PhD)
business coursework desirable
Minimum 5 years in Clinical Development Quality roles with increasing responsibility
Strong knowledge of GCP principles, clinical development process (Phases I–IV), and regulatory requirements
Project management, strategic planning, and complex decision-making skills
Excellent communication and stakeholder engagement skills (local and global)
Solid understanding of AI concepts and applications in clinical development
Ability to lead or significantly contribute to AI-driven initiatives (SSU, recruitment, eSource, etc)

Job Responsibility

Implement GCP QMS strategy locally
maintain Level 1 GCP quality documents
Ensure consistency with regulatory expectations through planning, monitoring, and continuous improvement
Act as Subject Matter Expert (SME) and point-of-contact for clinical quality requirements, promoting Quality-by-Design principles
Ensure inspection readiness and manage regulatory inspections with cross function
Serve as primary contact for audit response management as needed
Develop and execute Vendor Quality Plans
monitor vendor compliance
Drive remediation strategies for vendor quality issues and ensure timely resolution
Promote GCP quality culture across teams and vendors

Fulltime

Data Manager / Data Quality Leader

Contract opening for a Data Manager / Data Quality Leader within the USMA Data M...

Location

United States , South San Francisco

Salary:

Not provided

Revel IT

Expiration Date

Until further notice

Requirements

BS or MS in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry experience
Demonstrated strong collaboration and excellent communication skills-both written and oral (proficiency in English required)
Knowledge of CDISC data standards
Knowledge of ICH-GCP and working in regulated environment
Project Management skills
Able to manage multiple requests and priorities
Demonstrated leadership capabilities and decision-making, negotiation, motivation (self and others) and influencing
Experience with data analytics and/or visualization tools and techniques
Demonstrated entrepreneurial mindset and self-direction, ability to mentor others and willingness to learn new techniques
Knowledge of biological principles, display interest and demonstrate scientific curiosity including understanding of data types and their scientific use (clinical, biomarker, WGS, RNA-seq, etc.

Job Responsibility

Ensure the timely completion of data management deliverables and partner with Functional Service Providers (FSPs), DM CROs and other vendors, overseeing and providing technical expertise in the delivery of high quality data
Contribute to functional, cross functional, enterprise-wide or external initiatives that shape our technical landscape, business and healthcare environments
Require strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to evolve the way we collect and deliver data and to develop and deliver medicines for our patients
DM lead will contribute to the development of new concepts, technologies, and standards. In addition to demonstrating high proficiency with core DM tasks (being able to work independently with minimum oversight/supervision), provides leadership and strategic direction to DM members and adapts strategies to meet changing needs of program objectives
Project Management: Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies & projects, including the implementation and adoption of new technologies
Stakeholder Management: Proactively engage with stakeholders across the business to understand their needs and influence their understanding of decisions made in our function. Inform stakeholders of key deliverables and act on changing milestones
Vendor Management: Partner with relevant functions for external data vendor selection and management. Oversee development of data transfer agreements with vendors ensuring use of standards, fit-for-purpose data models and transfer intervals
Data Collection and Acquisition: Act as experts for data collection, advising teams and stakeholders on best practices and proposing innovative solutions. Ensure high quality data and compliance with applicable regulations and standards
Provide Data Solutions: Stay current with and adopt emergent data collection, data management, visualization and provision tools and applications to ensure fit-for-purpose and impactful approaches. Deliver on solutions as needed
Data Quality Review: Use data surveillance tools and strategies to provide aggregate level reviews designed to identify patterns or anomalies in our data to ensure high quality results

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GCP Quality Compliance Manager

Job Description

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