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Sr. Director of Quality Assurance

3 months ago

Fremont, United States Asahi Kasei Full time
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:

Company Summary:

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, agility and an interest in transformative action are also common attributes among our team.

Position Summary

The Sr. Director of Quality Assurance will provide leadership and QA oversight of end to end operations and systems activities, including client facing interaction, self-inspection program, audit and inspection management, inspection readiness, supplier qualification program and raw materials program, amongst others.

Duties and Responsibilities
  • Lead the Compliance and Quality Assurance organization responsible for QA oversight of compliance programs and supplier qualification program.
  • Implement and maintain a compliant QMS that is fit for purpose (clinical vs commercial) and follows and improves business performance and efficiency. Including measurement of the effectiveness of the QMS highlighting areas of risk/improvement to Site Leadership governance structure (e.g. Management Review).
  • Participate as subject matter expert in deviation management investigations, CAPA and effectiveness check processes for continuous improvement and inspection readiness. Overall responsibility for management of the site inspection readiness, compliance standing and supplier qualification program.
  • Establish and manage the Inspection Readiness program, Supplier Qualification program and overall Supplier lifecycle program.
  • Manage relationship with clients' QA organization.
  • Define and maintain a strong people management, training, and engagement culture to ensure a high and constantly improving right first time rate in Bionova operations.
  • Identify, recruit and manage the QA team under his/her area of responsibility, implementing a strong quality culture and ensuring staff engagement and development in line with the site competency framework. Own the succession plan for the team ensuring business continuity and staff retention/engagement.
  • Act as deputy for the SVP Quality and Compliance.
  • Perform other duties as assigned commensurate with job grade.
Working Conditions:
  • This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 5 pounds independently.
Qualifications
  • Bachelor's degree in Engineering, Life Sciences, or related discipline with 15+ years of relevant experience, or combination of experience and relevant advanced degree.
  • In-depth understanding of technical documentation and knowledge of regulations: 21 CFR, ANNEX 1, ICH Q, etc.
  • Experience leading and participating in regulatory inspections, client audits, etc.
  • Flexible mindset for a dynamic environment.
  • Strong project management capabilities.
  • Ability to independently evaluate technical situations and propose potential solutions.
  • Ability to communicate clearly and professionally in writing and verbally.
  • Flexibility with work hours to meet business needs.
  • Strong analytical and problem-solving skills

Compensation Range: The base compensation range for this role is between $180,000 and $220,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

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.