Senior Director, Quality Control (Biopharmaceuticals, Remote)

Job summary

The Senior Director of Quality Control is responsible for providing strategic, scientific, and operational leadership for quality control activities within a biopharmaceutical organization. This role focuses on developing internal capabilities to support the development, manufacturing, and commercialization of the company's product portfolio, ensuring a transition to a fully integrated, commercial-stage biotechnology company.

Qualifications

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

Responsibilities

• Define and implement a comprehensive 3–5 year QC strategy, including capability building and investment prioritization.
• Establish a future-state vision for QC, incorporating digital laboratories and advanced analytics.
• Lead the evolution of the QC operating model to support commercial readiness.
• Ensure compliance with global GxP standards and oversee investigations of deviations and laboratory events.
• Build and develop a high-performing QC organization aligned with growth objectives.

Skills

• Strong leadership and strategic advisory capabilities.
• Expertise in regulatory inspections and health authority interactions.
• Experience in driving digitalization and data integrity initiatives.
• Strong business acumen linking QC strategy to commercial success.

Education

• Advanced degree in a relevant scientific field.

Tools

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