Associate Director, Data Integrity and Compliance
This is a newly created opportunity to join an established company going through an exciting period of growth. A market leader in their specialist area of drug development and manufacturing, you’ll be able to establish the data integrity program across disciplines and ensure alignment with regulatory requirements and industry standards in accordance with relevant data lifecycle requirements, as well as being responsible for the DI program.
- Primary responsibility for conducting data integrity assessments of new and existing manufacturing and laboratory systems to ensure compliance with regulatory requirements. and
- Execute data integrity processes for automated systems in conjunction with computerized system development life cycle (SDLC) methodologies to ensure computerized systems meet regulatory requirements, company requirements and align with industry standards.
- Establish the company’s requirements for data integrity, audit data from Quality Control Laboratories, Manufacturing, Engineering and GMP-IT Systems
- To be the Lead in developing and maintaining the Data Integrity System for the global sites, including ownership, development, and implementation of Data Integrity SOPs.
- Data management (e.g., data creation, data processing, re-processing, review, reporting), data security, data traceability/process mapping, data backup/restore, electronic signature/ record linking and data audit trails.
- Present on the data integrity program inclusive of assessment status to Quality and company leadership.
- Collaborate with cross-functional teams to determine applicability of data integrity regulations, policies and procedures.
- Take the lead for the Core DI team and sub-teams to monitor data integrity assessment progress and remediation needs.
- Knowledge of global regulations and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) regarding quality systems and computer system validation in Biotech, Med Device, and the Pharmaceutical industry.
- 8 years’ experience in the Life Sciences industry, ideally with exposure to all clinical phases through commercial drug product
- Bachelor’s degree in Engineering, life sciences or technical related field required.
- Technical understanding of biopharmaceutical and computer systems. (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11) Organized individual who is experienced working with an oriented mindset in a CDMO environment.
- Demonstrated capacity to influence cross functional senior management to ensure project success.
- Able to educate all functional areas of the importance of data integrity
- Excellent written and verbal communication skills including the ability to influence and negotiate across the organization.
- Sense of urgency with the ability to multi-task, utilize effective time management, with strong attention to detail
- Excellent customer service skills. A professional and collaborative team player with strong interpersonal skills.
- Honesty, integrity, respect and courtesy with all colleagues.
- Driven to accomplish goals balanced with appropriate level of flexibility and input.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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