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About the Role
As the Site Quality Director, you will lead the CDMO Quality and Regulatory team, ensuring outstanding quality standards and compliance across aseptic operations. This role champions a culture of excellence and innovation, strictly adhering to regulatory guidelines and GXP compliance requirements.
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.
Requirements
- 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.
Skills
- Quality Management
- Regulatory Compliance
- Aseptic Operations
- Leadership
- Talent Development
- Communication
- Presentation Skills
- Strategic Planning
- Attention to Detail
Location
- Singapore
Work Type
- Onsite
Experience Level
- 15+ years in pharmaceutical industry
- 10+ years leadership experience
- 5+ years as Qualified Person (preferred)
Salary/Compensations
- S$201,000.00–S$335,000.00
About the Company
- Pharma Services Group / Drug Product Division - Singapore Site