Quality Assurance Operation Manager
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Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving analytical challenges growing productivity in their laboratories improving patient health through diagnostics or the development and manufacture of life-changing therapies we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies purchasing convenience and pharmaceutical services through our industry-leading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services Patheon and PPD.
How will you make an impact
As the Quality Assurance Operational Manager you will lead and oversee all QA Operations activities supporting sterile Drug Product manufacturing at the Swindon site. You will ensure compliant batch disposition real-time GMP oversight robust validation and qualification governance and effective execution of Quality Systems.
You will directly manage the Quality Operations Quality On the Floor staff QP team and the Qualification & Validation (Q&V) organization ensuring product certification equipment/facility qualification and process validation activities are executed in full compliance with EU and US cGMP requirements.
As a key member of the Site Quality Leadership Team you will ensure inspection readiness operational excellence and strong regulatory compliance while developing high-performing QA QP and Validation teams.
This role is critical to ensuring safe compliant and timely product release while maintaining operational efficiency and sterility assurance.
What will you do
QA Operations Leadership
- Lead and manage QA Operations teams supporting sterile manufacturing filling inspection and packaging.
- Ensure effective QA presence and GMP oversight on the shop floor including aseptic operations and contamination control.
- Provide real-time GMP guidance and quality decision-making support to Manufacturing Engineering QC Supply Chain.
QP Team Leadership & Product Certification
- Directly manage the site Qualified Person (QP) team.
- Ensure compliant batch certification in accordance with EU Directive 2001/83/EC and Annex 16.
- Oversee batch record review processes to ensure robust and timely product disposition.
- Ensure QP oversight of deviations changes validation status and regulatory commitments impacting certification.
- Maintain readiness for regulatory inspections related to product release and certification.
Qualification & Validation Oversight
- Lead and manage the Qualification & Validation (Q&V) function for the Swindon site.
- Ensure compliant lifecycle management of:
- Facility qualification (cleanrooms utilities)
- Equipment qualification (IQ/OQ/PQ)
- Computer System Validation (CSV) / digital systems
- Process Validation (including aseptic process simulation)
- Cleaning validation
- Continued Process Verification (CPV)
- Ensure alignment with EU GMP Annex 15 and FDA process validation guidance.
- Ensure validation master plans are current and risk-based.
- Provide strategic oversight of validation resource planning and execution timelines.
Sterile & Aseptic Compliance
- Ensure robust oversight of aseptic processing and contamination control strategy (CCS) in accordance with EU GMP Annex 1.
- Ensure qualification and validation programs support sterility assurance.
- Support risk assessments related to sterile manufacturing operations and technical changes.
Deviation Investigation & CAPA Oversight
- Ensure high-quality and timely investigations using structured root cause methodologies.
- Drive sustainable CAPA implementation and effectiveness checks.
- Monitor quality metrics and identify trends to prevent recurrence.
Inspection & Audit Readiness
- Maintain a constant state of inspection readiness across QA QP and Validation functions.
- Lead QA representation during regulatory inspections (MHRA FDA EMA) and customer audits.
- Ensure effective and sustainable remediation of audit findings.
Quality Systems & Governance
- Ensure effective implementation and governance of core Quality Systems (Change Control Deviations CAPA Risk Management).
- Ensure validation and qualification activities are fully integrated within the Pharmaceutical Quality System.
- Escalate quality risks appropriately to site leadership and corporate quality.
People Leadership & Development
- Lead coach and develop QA Operations QP and Validation teams.
- Build strong succession planning for QP eligibility and validation technical expertise.
- Foster a culture of accountability compliance and continuous improvement.
- Strengthen sterile GMP and validation competencies across the organization.
How will you get here
Education
- Degree in Pharmacy Chemistry Biology/Biotechnology Engineering or related scientific/technical discipline.
- Eligible to act as a Qualified Person (QP) under EU requirements is highly desirable.
Experience
- Significant experience in pharmaceutical Quality Assurance within GMP manufacturing.
- Strong experience in sterile Drug Product manufacturing environments.
- Proven experience managing QP activities and product certification.
- Extensive experience in Qualification & Validation lifecycle management.
- Experience interacting with regulatory authorities (MHRA FDA EMA).
- Demonstrated people leadership experience.
Knowledge Skills & Abilities
- Strong knowledge of EU & US cGMP requirements (including Annex 1 Annex 15 and Annex 16).
- Deep understanding of aseptic processing and sterility assurance principles.
- Strong expertise in process validation and equipment qualification lifecycle.
- Strong risk management and decision-making capability in complex GMP environments.
- Ability to balance compliance patient safety and operational performance.
- Excellent stakeholder management and communication skills.
- Structured pragmatic and quality-driven leadership style.
Required Experience:
Manager
Key Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
