Sr. Director of Quality Control

Asahi-Kasei; Fremont (CA); Hybrid; USD 240,000 - 280,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K with 5% match plus 3% company

Paid time off

Annual Bonus eligibility

Job summary

Bionova Scientific LLC, a subsidiary of Asahi Kasei Medical, is seeking a Sr. Director of Quality Control in Fremont, CA. Lead the QC laboratories, set strategy, and ensure cGMP compliance across release, stability, and environmental monitoring.

The role requires an advanced degree and 15+ years in Analytical Sciences or GMP labs, with strong regulatory interaction experience. This hybrid position offers a competitive base salary and comprehensive benefits.

Qualifications

• Advanced degree required; 15+ years in Analytical Sciences, Quality Control, or GMP labs.
• Experience leading QC teams and driving regulatory compliance.
• Strong knowledge of biopharmaceutical development and cGMP requirements.
• Experience interacting with global regulatory agencies.

Responsibilities

• Provide strategic and tactical leadership for QC labs and operations.
• Apply analytical methods knowledge to support development, clinical, and commercial testing; troubleshoot investigations.
• Ensure compliance with global cGMP for release, stability, and environmental monitoring.
• Partner with clients and teams to assess risks and define analytical strategies.
• Oversee method development, transfer, qualification, and validation for programs.

Skills

Leadership

Analytical Sciences

Quality Control

GMP compliance

Regulatory interaction

Method development

Education

Advanced degree in Pharmaceutics/Biochemistry/Chemistry/Biochemical Engineering or related field

Job description

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.Company:Bionova Scientific LLCJob Description:The Sr. Director of Quality Control is a member of the Quality and Compliance Leadership Team responsible for leading Bionova Scientific’s QC function. This role sets strategy and provides oversight for sample management, stability, in-process and environmental monitoring, release testing, method transfer, qualification, validation, and related QC operations.The role supports client timelines by developing robust analytical transfer and qualification strategies in collaboration with clients and Bionova’s Analytical Development team.Location: Fremont, CABenefitsDirect HireMedical, Dental, Vision, 401K (match up to 5%, plus an additional 3%, total 8%)Paid time offAnnual Bonus eligiblePrimary Responsibilities:Provide strategic and tactical leadership for Bionova Scientific’s QC laboratories and related operations.Apply deep technical expertise in analytical methods to support development, clinical, and commercial testing, including troubleshooting and investigations.Ensure phase-appropriate compliance with global cGMP expectations for release, stability, and environmental monitoring programs.Partner with clients and internal teams to assess program risks and define analytical strategies that support timely, science-based decisions.Oversee method development, transfer, qualification, and validation for development and commercial programs.Partner with Quality Assurance to maintain fit-for-purpose QC quality systems and data integrity.Drive continuous improvement initiatives, performance metrics, and KPIs to improve laboratory efficiency, effectiveness, and process stability.Lead, coach, and develop the QC team to strengthen technical capability, compliance, and operational execution.Communicate goals, risks, decisions, and results effectively across development and commercial teams.Required Skills:Advanced degree in Pharmaceutics, Biochemistry, Chemistry, Biochemical Engineering, or a related discipline; equivalent experience may be considered.15+ years of leadership experience in Analytical Sciences, Quality Control, or a related GMP laboratory environment.Strong understanding of biopharmaceutical development, from cell line generation through market authorization.Direct experience interacting with global regulatory agencies.Strong experience with method optimization, transfer, qualification, and validation for release and stability testing.Extensive knowledge of cGMP requirements and data integrity expectations.The base compensation range for this role is $240,000-$280,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.#LI-MG1#hybridAs an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.