The Associate Director, Data Quality and Integrity will serve as the Quality Subject Matter Expert (SME) in Computer System Validation (CSV) and Data Integrity. This position will provide leadership, guidance, and training to the organization related to CSV and Data Governance. This role will also be responsible for implementing quality related policies and procedures related to Data Governance.
- Lead the development of the data integrity strategy for Adaptimmune to assure that an acceptable state of control is established and maintained based on identified risk.
- Lead the data lifecycle mappings to identify potential data integrity risks and work with cross-functional stakeholders to define the actions in line with the data integrity strategy.
- Collaborate with cross functional teams to develop policies and department specific procedures to ensure that an acceptable state of control is established and maintained in line with the Data Integrity Strategy.
- Establish adequate data integrity review process to verify the accuracy, consistency, completeness, and truthfulness of data (hardcopy and electronic) generated for GxP-related activities including data submitted to regulatory agencies.
- Partner with Information Management (IM), Business Process Owners (BPO), system administrators and other key stakeholders to ensure compliant system implementation and validation of all GxP computer systems.
- Lead the development of key policies and procedures pertaining to computer systems validation and related procedures in line with industry standards and regulatory requirements.
- Provide quality oversight for GxP computer systems through reviews and approval of system validation plans, validation reports, testing protocols, user requirements specification, and computer related procedures.
- Evaluate computer related change controls and incidents to ensure adequate testing and resolution are performed respectively.
- Lead the PAI readiness effort for GxP computer systems and serve as subject matter experts during regulatory inspections and third-party audits of software vendors.
Qualifications & Experience
- Minimum Bachelor's degree in Engineering, Quality, or Life Science discipline or significant experience with a minimum of 10+ years of experience in the pharmaceutical/biotechnology industry, 5+ years computer validation experience in quality assurance role.
- Strong knowledge and experience with GxP regulations and approaches to System Development Life Cycles (SDLC) and GAMP
- Knowledge of industry standard and guidance affecting Data Integrity preferred
- Demonstrated capability to lead a team and to execute tasks on time
- Must have a strategic perspective and be capable of synthesizing information and applying prior experience from multiple sources to build efficient and successful DI compliance and quality strategies for the organization.
- Successful interactions with regulatory bodies
- Expert at managing complexity and multiple work streams in changing circumstances
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.