Associate Director, Operational Quality - London, United Kingdom - Vertex Pharmaceuticals

Description

Associate Director, Operational Quality (External Manufacturing) page is loaded

Associate Director, Operational Quality (External Manufacturing)

Job Description

The Associate Director, Operational Area Quality will be responsible for leading the day-to-day Quality operations of Contract Manufacturing Organizations (CMOs) for Cell & Genetic Programs through the lifecycle development process. This includes quality oversight for the selection, qualification and routine monitoring of Contract manufacturers. The role will assure Quality oversight for technical and operational CDMO activities from clinical throughout product commercialization activities, post-approval process monitoring and change management. The role is also responsible for the development and maintenance of relationships with the external vendors, to drive compliance, monitor performance and support continuous improvement activities.

The quality role will closely partner with operational stakeholders and participate in associated governance for the successful planning and execution of the product life cycle Management. The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team and the Virtual Product Team.

Key Responsibilities:

• Be the Quality expert for European CMOs and CTOs.
• Build strategic relationships with CMOs and CTOs within the Quality organization and participates in Business Review Meetings to ensure Quality issues are raised and addressed, as necessary.
• Negotiate, monitor and maintain Quality Agreements with CMOs.
• Lead/Support/Execute Quality oversight for clinical and product commercialization activities.
• Lead quality process monitoring of the CDMO.
• Execute change management and vendor notifications as part of product life cycle management.
• Liaises with cross-functional teams for external quality commercial operations in support of GMP manufacturing and testing activities.
• Leads/executes continuous improvement activities and drive quality remediation.
• Work closely with the Audit and Inspection Quality Function to establish the audit strategy for Auditing and Performance oversight and support technical site audits including preparation for regulatory inspections.
• Establishment of vendor quality oversight processes including qualification, risk categorization and routine monitoring.
• Provide guidance and support through Quality representation in relevant geographies at periodic intervals on site at the CDMOs.
• Supports root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• Participate in Cell & Genetic Program and Quality projects.

Key Requirements:

• In-depth understanding on International regulations and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
• Experience in product life cycle from discovery and/ or commercial product development.
• Broad technical knowledge in cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Substantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
• 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.
• Substantial background in managing complex projects or teams within stated objectives and timelines and with a strong understanding of the underlying business drivers.

Education:

• Bachelor's degree or Master's degree or PhD in relevant subjects.

This position is Hybrid and requires min 3 days per week in the London office.

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

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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.