Senior Director of Quality Control (Biotechnology, Remote)

Job summary

The Senior Director of Quality Control is responsible for providing strategic, scientific, and operational leadership for quality control activities within a biotechnology organization. This role focuses on developing internal capabilities to support the development, manufacturing, and commercialization of biopharmaceutical products. The position aims to shape a future-ready QC organization that ensures scalable and compliant operations.

Qualifications

• PhD, MS, or BS in Biochemistry, Analytical Chemistry, Biotechnology, or a related life science field.
• Over 15 years of experience in biopharmaceutical or biologics Quality Control or Analytical Sciences, with significant leadership experience.
• Proven experience in building and transforming QC organizations, particularly for late-stage and commercial biologics.
• Expertise in biologics analytical testing methods such as HPLC/UPLC, CE-SDS, ELISA, and bioassays.
• Strong knowledge of GMP manufacturing and global regulatory standards.

Responsibilities

• Develop and implement a comprehensive 3–5 year QC strategy aligned with organizational goals.
• Establish a vision for QC incorporating digital laboratories and advanced analytics.
• Oversee internal QC laboratory operations to ensure timely and compliant testing for product release.
• Ensure compliance with global GxP standards and lead investigations of deviations and laboratory events.
• Build and develop a high-performing QC team, driving succession planning and leadership development.

Skills

• Strong leadership and strategic planning abilities.
• Excellent understanding of regulatory inspections and health authority interactions.
• Experience with digitalization initiatives in QC processes.
• Strong business acumen linking QC strategy to commercial success.

Education

• Advanced degree in a relevant scientific discipline is required.

Tools

• Familiarity with LIMS, ELN, and advanced analytics platforms.