Location: Swindon, UK (open to candidates from the EMEA region willing to relocate).
Position Summary
As the Site Quality Director, you lead the CDMO Quality and Regulatory team, ensuring outstanding quality standards and compliance across our aseptic operations. This opportunity allows you to champion a culture of excellence and innovation, strictly adhering to regulatory guidelines and GXP compliance requirements.
Key Responsibilities
* Lead and manage the Site Quality and Regulatory team, establishing and maintaining flawless quality and compliance levels.
* Maintain and continuously improve the site quality systems and processes.
* Identify, develop, and retain top-tier talent, ensuring a strong succession plan.
* Foster a collaborative and inclusive culture that prioritizes quality and compliance.
* Develop and maintain proactive relationships with regulatory authorities and clients.
* Maintain an independent authority for any decision impacting Quality.
* Act as a role model, embodying Thermo Fisher values and driving groundbreaking change.
* Act as a member of the DPD EU & APAC QLT and partner across the organization with sister sites and global functions.
How You Can Make an Impact
* Proven track record of 15+ years in the pharmaceutical industry including sterile drug products and aseptic operations. Preferred experience with CDMO, biotech, and vaccine production.
* 5+ years acting as a Qualified Person is preferred.
* Extensive knowledge of quality structures and regulatory bodies.
* 10+ years of leadership experience, successfully developing high-performing teams.
* Outstanding communication and presentation skills, capable of engaging senior executives.
* Strong ability to attract, hire, and develop diverse talent.
* Proactive and strategic approach, skilled at moving between details and the “big picture.”
* Learning agility with attention to detail.
* Demonstrated ability to make calculated, high-impact quality decisions and get results.
Join us to craft the future of our Quality function and make a tangible impact on global health initiatives!
Details
* Seniority level: Not Applicable
* Employment type: Full-time
* Job function: Quality Assurance, Product Management, and Engineering
* Industries: Pharmaceutical Manufacturing and Biotechnology Research
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