Director/Senior Director, Quality & Compliance (GxP)

Director/Senior Director, Quality & Compliance (GxP)

Location: Babraham Research Park, Cambridge

Type: Full time, permanent 

Salary: Competitive / Hours: 40 p/w

Cambridge Based Position - hybrid working available

Your role in our team:

We are looking to recruit an experienced Director/Senior Director, Quality & Compliance (GxP) who will lead and drive the execution of bit.bio’s quality strategy from research, launch, commercialisation, and product lifecycle management for both our research use only and clinical products. This individual will be the leader for all Quality and Compliance functions and activities, including but not limited to GxP (GMP, GCP, GCLP, GLP, GTP, GVP), HTA, GDPR, and other relevant regulations and standards.

Reporting to the VP, Quality & Compliance, the Director/Senior Director will be responsible for implementing bit.bio’s quality management system to support research product and clinical product programs on a global level.

This is an excellent opportunity to contribute to the build-out and scale-up of a GxP focused quality organisation on a global level.

Your key responsibilities will include:

• Directs, establishes, and maintains Quality and Compliance programs, policies, and procedures to ensure GxP and RUO product quality and compliance, including but not limited to internal and external audits, supplier qualification, and issue management.
• Collaborates with management to establish strategic plans and objectives. Makes final decisions on implementation and ensures operational effectiveness. Effectively cascades functional strategy and contributes to development of organizational policies.
• Leads team(s) to develop new methods and solve complex matters.
• Hosts or supports regulatory inspections and business audits.
• Develops policies and procedures that comply with regulatory requirements and meet business needs.
• Acts as the technical subject matter quality expert for all matters governed by GMP related regulations and guidelines as it relates to manufacturing, testing and analytical controls.
• Leads and supports activities related to external quality such as, but not limited to, development of process and analytical methods, tech transfers, deviations/investigations, quality agreements, lot dispositions, supplier and contract manufacturing selection and qualifications.
• Leads management and product review meetings. Provides quality oversight of key CMC and IND/CTA enabling documents. Reviews and verifies process data to assure compliance with data integrity.
• Drives process and product quality through effective quality systems and supplier oversight/surveillance.
• Represents Quality & Compliance on project teams, regulatory inspections, suppliers and CDMO operational meetings, and QA to QA meetings.

You…

• Have a life science degree (or equivalent experience) and significant experience of quality assurance and compliance to GxP gained within the pharmaceutical or biotechnology sector, with a focus on GMP
• Have knowledge of and experience with biological products (vaccines, MAbs or equivalent); exposure to/knowledge of gene and cell therapies highly desirable
• Are a strong team-oriented communicator, dedicated to contributing to the next generation of pioneering therapies for patients 
• Are a highly motivated individual with a proven track record in ensuring cross-functional and multi-dimensional project delivery
• Have complete understanding and wide application of technical principles, theories, concepts and techniques as it relates to quality assurance and compliance
• Have the ability to work on problems of diverse scope where analysis or data requires evaluation of identifiable factors 
• Have strong analytical and business communication skills; are an excellent verbal, written and oral communicator 

With essential experience in…

• Strong knowledge of the clinical manufacturing and quality processes, including US and EU regulations affecting the pharmaceutical industry and ICH guidelines.
• Experience in hosting regulatory inspections and business audits.
• Experience in conducting and overseeing GxP audit, with focus in GMP.
• Has a significant amount of experience in a virtual manufacturing environment or relevant industry/profession.
• Guides the successful completion of major programs, projects and/or functions.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy.
• Leads the implementation of process and system improvements/initiatives with minimal guidance.
• Interprets, executes and recommends modifications to companywide policies and procedures.
• Experience in supplier qualification.
• Experience in personnel management and people development.
• Ability to make timely and sound quality decisions when faced with complex supply, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Hands-on experience in manufacturing and/or analytical testing & development.
• A successful track record of working with suppliers and CDMOs.
• Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the biopharmaceutical industry.
• Experience in forming, developing, motivating, and retaining high-performing team

…and possibly…

• Experience in genetic and cellular therapy (strongly preferred)
• Understanding of QP requirements and processes
• Understanding of computer system validation for GxP systems
• Understanding of equipment qualification and validation
• Understanding of health & safety controls in laboratory environment in the UK
• Experience using and managing eQMS such as Veeva or MasterControl