Sr. Director of Quality Control

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

Benefits offered by this job

Direct Hire

Medical, Dental, Vision, 401K (match 5

Paid time off

Annual Bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA seeks a Sr. Director of Quality Control to lead the QC laboratories and quality systems, ensuring compliant testing across development, clinical, and commercial programs.

You will set strategy for method transfer, validation, and release testing, partner with clients and regulatory bodies, and coach the QC team to deliver timely, science-based decisions while advancing cGMP compliance.

Qualifications

• 15+ years of leadership experience in Analytical Sciences, Quality Control, or GMP labs.
• Strong understanding of biopharmaceutical development and regulatory expectations.
• Experience interacting with global regulatory agencies and leading method transfer/validation.

Responsibilities

• Provide strategic and tactical leadership for Bionova Scientific’s QC laboratories and operations.
• Oversee method development, transfer, qualification, and validation for development and commercial programs.
• Ensure phase-appropriate compliance with global cGMP expectations for release, stability, and environmental monitoring.
• Lead, coach, and develop the QC team to strengthen technical capability and compliance.
• Communicate goals and results across development and commercial teams.

Skills

People leadership

Regulatory understanding

cGMP knowledge

Analytical testing

Quality strategy

Education

Advanced degree

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 LLC

Job 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, CA

Benefits

• Direct Hire
• Medical, Dental, Vision, 401K (match up to 5%, plus an additional 3%, total 8%)
• Paid time off
• Annual Bonus eligible

Primary 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.

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As 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.