Quality assurance manager Work, Jobs in Fulbourn, Cam (with Salaries)

Head of Quality
AdventBio —Sawston
- Master's degree
- Quality control
Quick apply
9d
Professional Development Manager (Trainer Quality)
Cambridge University Press & Assessment —Cambridge
- £35,200 - £45,700 a year
- Hybrid work
- Project management
- Travel
- IT
- Annual leave
Quality Assurance Manager
Taylor Woodrow —Bury St. Edmunds
- Full-time
Quick apply
Technical Quality Manager
M Group —Bury St. Edmunds
- Analysis skills
- Construction
- Free parking
- Employee assistance programme
Quality Compliance Manager
Marshall of Cambridge (Holdings) Limited —Cambridge
- Full-time
- Management
- Team management
- Travel
Director, Quality Assurance (Diagnostics & Devices)
AstraZeneca —Cambridge
- No degree
4d
Quality Manager
Bilfinger SE —Royston
- Temporary
- No experience needed
6h
Quality Manager
Mettler Toledo —Royston
- Data analysis skills
- SharePoint
- Annual leave
Water Quality and Regulations Manager
South Staffs Water —Cambridge
- Up to £52,000 a year
- Full-time
- Bachelor's degree
- Travel
- Leadership
- Employee assistance programme
Product/Quality Manager
Palma Ceia SemiDesign —Cambridge
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Lead Quality Assurance Engineer - FTC 6 Months
The Delta Group —Bishop's Stortford
- Hybrid work
- Azure
- Mentoring
- Scripting
Quick apply
16h

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quality assurance manager jobs near fulbourn, cam

Head of Quality

AdventBio
Sawston

Quick apply

Job details

9 days ago

Qualifications

Microbiology
Master's degree
Quality assurance
Quality control

Full job description

We are currently seeking a Head of Quality to lead and manage the strategic and operational performance of our Quality teams.

Company Information

Advent Bioservices is a Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using advanced therapy medicinal products.

Job Summary

The Head of Quality will work with the President and Senior Managers to ensure the efficient and effective day to day running of the QA, Validation and QC department, ensuring the design elements and the implementation of the PQS meet the relevant regulatory compliance requirements, managing all activities supporting pharmaceutical product manufacture, testing and certification, as well as being responsible for approving and releasing unlicensed medicine manufactured under Advent's MHRA Specials license.

Key responsibilities will include:

Lead and implement the companys quality strategy in line with business goals and GMP/UK regulatory requirements
Maintain and continuously improve a robust Quality Management System (QMS)
Champion a culture of quality, compliance and patient safety across the organisation
Provide quality leadership across commercial, clinical and development stage cell therapy products
Act as the primary quality regulatory inspections and client audits

Quality and Compliance

Oversee and enhance the eQMS
Montior QMS performance and drive continuous improvement initiatives
Ensure ongoing regulatory compliance and maintenance of licences
Lead internal GMP audits, supplier audits and regulatory inspections
Manage investigations, including deviations, complaints and out of specification results
Develop and maintain SOPs, QC protocols and quality documentations
Analyse and present quality and operational performance data

Technical and QC Oversight

Oversee QC operations for ATMPs including testing, validation and release activities
Approve raw materials, packing components and finished products
Manage environmental monitoring and microbiological control programmes
Ensure validation of analytical methods, equipment and laboratory systems
Oversee stability programmes, sampling plans and contract testing
Provide QC guidance and support to manufacturing teams

Validation and Equipment

Ensure validation strategies for facilities, utilities and equipment comply with regulatory standards
Support validation activities across production and QC
Oversee maintenance, qualification and compliance of laboratory environments and equipment

Leadership and Management

Lead QA, QC and Validation teams
Drive companywide training and awareness of quality systems
Support senior leadership and business development activities
Provide strategic oversight across quality and operational functions

Regulatory and External Engagement

Act as main contact for regulatory authorities, clients and external partners
Support Qualified Person (QP) activities
Ensure compliance with MHRA, GMP, ATMP and HTA requirements

The successful candidate will have the following experience/qualifications:

MSc in relevant scientific discipline (Pharmaceutical Sciences, Biotechnology, Biochemistry) or equivalent.
Significant experience working as a senior quality manager within a GMP Quality department in the manufacture of cell and/or gene therapy products
Experience of liaison with regulatory authorities (HTA and MHRA)
Experience in establishing and maintaining a Contamination Control Strategy
Experience of validation of facilities and equipment
Demonstrated knowledge of Quality Control, Quality Assurance, validation, GMP, MHRA Regulatory Compliance and testing and packaging of ATMPs
Experience of Regulatory Compliance and testing and packaging of ATMPs
Ability to interpret complex data and present key findings
Good documentation practice and QC reporting
Experience of microbiology and analytical methods in cell therapy

The is a fantastic opportunity to join a growing organisation. We offer an attractive base salary and benefits package.

Candidates must have the eligibility to work within the UK.

We are not accepting agency applications for this position.

Quick apply

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quality assurance manager jobs in fulbourn, cam

Head of Quality

Professional Development Manager (Trainer Quality)