Quality assurance manager Work, Jobs in Farleigh, Sry (with Salaries)

Director QA, GMP External Operations Cell and Genetic Therapies - VCGT
Vertex Pharmaceuticals —Paddington
- Full-time
- Master's degree
- Bachelor's degree
- Travel
Care Home Quality Improvement Manager
Excelcare Holdings —Bromley
- Up to £66,462 a year
- Full-time
- Hospital
- Care experience
- Travel
- Free parking
- Employee discount
Quick apply
11d
Quality Manager - Tutorials & Pastoral Care
LSEC —London
- £52,549 - £59,408 a year
- Full-time
- University
- Teaching
- Annual leave
- Employee assistance programme
Education & Quality Lead
M:Tech Education —Guildford
- £35,000 - £40,000 a year
- Full-time
- Microsoft Office
- Organisational skills
- Classroom experience
Quick apply
3d
Quality Assurance Manager
Regent College London —London
- £50,000 a year
- Full-time
- Project management
- No degree
- Organisational skills
Quick apply
Qualified Person (QP) / Senior Quality Assurance Manager
Procter & Gamble —Weybridge
- Full-time
- English
- Communication skills
- Employee stock ownership plan
Director of Quality
CECOS College London —London
- £80,000 - £100,000 a year
- Full-time
- Master's degree
- Analysis skills
- Project management
Quick apply
12d
Head of Apprenticeship Development and Quality
Ruskin Mill Trust —Forest Row
- £42,567 - £50,605 a year
- Full-time
- Education
- In-person
- Leadership
- Free parking
Quick apply
10d
Virology Quality Manager (ID4629)
Animal and Plant Health Agency —New Haw
- £38,795 - £41,375 a year
- Overtime
- Computer literacy
- Microsoft Office
- Presentation skills
- Annual leave
- Employee discount
Quality Assurance Manager
Toyota Connected Europe —London
- Hybrid work
- Continuous improvement
- Software development
- Leadership
14d
Head of Investigations & Quality (Safeguarding) (7367)
Save the Children —London
- £61,500 a year
- Full-time
- Remote
- Analysis skills
- Mentoring
- IT
- Annual leave
- Employee assistance programme
Senior Service Quality Manager
NEST —London
- £60,000 - £70,000 a year
- Hybrid work
- Analysis skills
- IT
- Financial services
4d
Quality Assurance Senior Lead - Sanctions
Wise Australia Investments —London
- £83,000 - £110,000 a year
- Management
- English
- Financial services
Assistant Director, Quality Assur...
General Medical Council —London
- £130,000 - £140,000 a year
- Communication skills
13d
Head of Quality Assurance & QS (Electrical)
Current Affairs Electrical Contractors Ltd —Frant
- £60,000 - £75,000 a year
- Full-time
- Analysis skills
- Project management
- In-person
- Profit sharing
Quick apply
11d
TEST MANAGER - LEAD CONSULTANT
Scale Factory —London
- Hybrid work
- Driving
- Mentoring
- Agile
- Annual leave
Clinical Quality Assurance - Program Lead (Associate Director)
Novartis —London
- £63,917 - £118,703 a year
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
Lead OAT Tester (SC Eligible/ Cleared)
Scrumconnect Consulting —Staines-upon-Thames
- £55,000 a year
- Azure
- AWS
- Continuous improvement
3d
Quality Assurance Manager
Carepoint Services Limited —Lewisham
- £32,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Management
Quick apply
Quality Assurance Manager
Taiko —Acton
- £45,000 a year
- Full-time
- Communication skills
- Employee discount
Quick apply

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Director QA, GMP External Operations Cell and Genetic Therapies - VCGT

Vertex Pharmaceuticals -
Paddington

Apply Now

Job details

Full-time

Qualifications

Master's degree
Six Sigma
Bachelor's degree
Root cause analysis
Communication skills

Full job description

Job Description

General/Position Summary

The Director , Quality Assurance GMP Operations is responsible for the applicable Cell & Gene CDMO and is responsible for the end to end quality oversight of all product and activities at the CDMO. Responsibilities include day-to day operational quality oversight including assuring progression of batch record operations , resolution and on time disposition of product, quality continuous improvements, changes associated with the process and associated implementation, trends, and overall quality performance of the CDMOs .

The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities and participat ion in governance committees . A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities . The role may also be required to support on site manufacturing activities at the CDMO .

Key Duties & Responsibilities

Establishment of quality oversight for external C T O/C D MO operations including assurance of on time of batch disposition process , across development, launch and commercial manufacturing globally.

Lead, Develop, and implement continuous quality improvements to a dvanc e quality outcomes and operational excellence in processes.

Proactively develop Compliance metrics as key indicators and takes action to mitigate .

Maintain full oversight of CDMO QMS including driving deviation reduction a nd assuring timely resolution of CAPAs.

Act as the SME for the CDMO , understanding scope of all changes, driving applicable global change control implementation with the external manufacturing partner to meet global product goals.

Represent Quality and serve as a trusted partner for the disposition activities of drug product.

Build strategic relationships and foster a culture of collaboration with internal and external partners – CDMOs and CTOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary.

L ead/support the development of quality & technical risk mitigation through identification and mitigation compliance gaps .

Lead and mentor other team members, support development of organizational capabilities and talent building.

Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits.

Establish /parti ci pate and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.

Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.

Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.

May be required to support manufacturing on site activities.

Required Education Level

Batchelor 's degree or relevant comparable background.

Masters preferred.

Required Experience

10 + years of experience and 5 + years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21CFR Part 1271, GxPs ).

Broad and c urrent knowledge of batch disposition industry trends and best practices in Cell/Gene therapies.

Preferred QA Operational experience for Autologous Cell Therapy Operations.

Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.

Demonstrated strategic planning and execution skills required for operational effectiveness and compliance. P roven ability with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.

Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.

Ability to apply risk management principles to decision making and operational priorities.

Critical Thinking and Problem Solving skills

Ability to closely collaborate and build relationships with internal and external stakeholders .

Other Requirements
Indicate required certifications, licenses or specialized trainings.

Up to 25 % Travel may be required

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

Apply Now

Refine Your Search

quality assurance manager jobs in farleigh, sry

Director QA, GMP External Operations Cell and Genetic Therapies - VCGT

Care Home Quality Improvement Manager

Quality Manager - Tutorials & Pastoral Care

Education & Quality Lead

Quality Assurance Manager

Qualified Person (QP) / Senior Quality Assurance Manager

Director of Quality

Head of Apprenticeship Development and Quality

Virology Quality Manager (ID4629)

Quality Assurance Manager

Head of Investigations & Quality (Safeguarding) (7367)

Senior Service Quality Manager

Quality Assurance Senior Lead - Sanctions

Assistant Director, Quality Assur...

Head of Quality Assurance & QS (Electrical)

TEST MANAGER - LEAD CONSULTANT

Clinical Quality Assurance - Program Lead (Associate Director)

Lead OAT Tester (SC Eligible/ Cleared)

Quality Assurance Manager

Quality Assurance Manager

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