Sr. Director of Quality Control

Asahi Kasei•Fremont, CA

2d•Hybrid

About The Position

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.

Requirements

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.

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.