Senior Director, QC & Analytical Excellence

Bionova Scientific; Fremont (CA); Hybrid; USD 240,000 - 280,000; Full time

Benefits offered by this job

Direct Hire

Medical

Dental

Vision

401K

Paid time off

Annual bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA is seeking a Sr. Director of Quality Control to lead all QC operations and set strategy for release, stability, in-process and environmental monitoring programs.

You will guide analytical transfer, qualification, and validation, collaborating with clients and the Analytical Development team to meet timelines. This senior leadership role requires 15+ years in Analytical Sciences or GMP environments, with direct regulatory agency experience and a strong

Qualifications

• Advanced degree in Pharmaceutics, Biochemistry, Chemistry, Biochemical Engineering, or related discipline.
• 15+ years in Analytical Sciences/QC or GMP lab leadership.
• Strong understanding of biopharmaceutical development from cell line to market authorization.
• Experience with interactions with global regulatory agencies.
• Expertise in method optimization, transfer, qualification, and validation for release and stability.
• Deep knowledge of cGMP and data integrity.

Responsibilities

• Provide strategic and tactical leadership for QC laboratories and related operations.
• Apply deep technical expertise to support development, clinical, and commercial testing; troubleshoot and investigate.
• Ensure phase-appropriate compliance with global cGMP for release, stability, and environmental monitoring.

Skills

Leadership

Regulatory interaction

Analytical development

Data integrity

Cross-functional collaboration

Education

Advanced degree in Pharmaceutics/related field

Job description

Bionova Scientific LLC in Fremont, CA is seeking a Sr. Director of Quality Control to lead all QC operations and set strategy for release, stability, in-process and environmental monitoring programs.

You will guide analytical transfer, qualification, and validation, collaborating with clients and the Analytical Development team to meet timelines. This senior leadership role requires 15+ years in Analytical Sciences or GMP environments, with direct regulatory agency experience and a strong