GDP Operational Quality Manager

GDP Operational Quality Manager page is loaded GDP Operational Quality Manager Apply locations Paddington, United Kingdom time type Full time posted on Posted 3 Days Ago job requisition id REQ-25782

Job Description

GDP Operational Quality Manager is an internal technical resource in the application of quality assurance and compliance principles to a wide range of disposition activities. The Manager coordinates or executes activities on multiple projects and takes a role in the design and execution of new projects.

Key Duties and Responsibilities:

• Provide quality oversight and support to operations at the Vertex Annex Drug Product Facility in the following key areas: support of manufacturing operations across all phases (development and commercial), support of analytical laboratory operations, and materials management.
• Oversee commercial and clinical batch disposition process. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
• Approve clinical and commercial lot COAs, generating BSE/TSE statements and product labelling
• Archive batch records and other supporting documents
• Generate and analyze performance metrics and trends, including site metrics for disposition, investigations, CAPA, etc.
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and consequential quality issues; provide direction for product disposition decisions including shipment.
• Review and approve Manufacturing documents e.g. MCR, MBR, Recipe, Engineering Parameters etc.
• Affirm raw material release, area clearance and equipment release.
• May assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
• Provide QA support of development and commercial change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
• Lead compliance walkthroughs of the site and help close any observations.
• Identifies risks, communicates gaps, and recommends optimized processes for GMP process/systems, area/equipment release, material disposition, etc.; execute process improvement initiatives to realize efficiency gains
• Support new product introduction into the Drug Product Facility by reviewing and approving new MBRs and material master files.
• Participate in inspection readiness activities and provide support during regulatory site inspections.
• Provide important compliance guidance to business owners; cultivate productive, collaborative relationships and mutual understanding of business needs

Knowledge and Skills:

• Strong foundation and demonstrated experience in:
• providing QA support and oversight of GMP manufacturing operation including batch release
• drug product development and manufacturing
• cGMPs and associated CMC regulatory considerations in a pharmaceutical environment
• Equipment, facilities and utility system qualifications under cGMP
• Leading event investigations, Root Cause Analysis (RCA), and CAPA
• Applications such as Oracle and TrackWise

Education and Experience:

• B.S in scientific or allied health field
• Extensive experience or the equivalent combination of education and experience

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 Program and may be changed at any time.

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

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases - cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia - and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram .

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.

Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.