Biologics Network Quality Advisor

Role Summary

Biologics Network Quality Advisor. You will play a pivotal role in ensuring robust support for Quality processes related to multi-site USDA licensure including regulatory submissions and deviation management. This role involves extensive cross-functional collaboration to drive continuous improvement in quality performance and culture across multiple sites.

Responsibilities

• Help define strategic action plans and priorities for the Quality agenda to drive continuous improvement. Provide tactical support for Quality Assurance and compliance processes and initiatives.
• Act as an Alternate Liaison for Elanco‚Äôs USDA Establishment, managing submissions and interactions with USDA-CVB.
• Leverage external benchmarking and networking to pinpoint strategic improvements for Compliance and overall performance. Construct robust business cases, articulate strong rationales and value propositions, and champion these projects/initiatives for Senior Leader approval.
• Serve as a key team player in Deviation Review Boards, guiding investigations and driving excellence in deviation handling.
• Coach and mentor colleagues in technical writing for regulatory submissions, conduct on-site visits to assess Quality System effectiveness and lead sites through optimization initiatives.

Qualifications

• Required: Bachelor's degree in biochemistry, chemistry, virology, biology, or a science-related field.
• Required: A minimum of 10 years of experience in the vaccine/Biotech industry.
• Required: Thorough knowledge of regulatory requirements for Biotech products (USDA 9CFR, FDA, EU-GMP) and deep technical knowledge of manufacturing processes and analytical methods for Biotech products, including Sterility Assurance.
• Preferred: Master‚Äôs or PhD in biochemistry, chemistry, virology, biology, or a science-related field.
• Preferred: Demonstrated coaching and mentoring capabilities.
• Preferred: Ability to set up partnerships with relevant functions to resolve quality and compliance issues.
• Preferred: Versatility in conflict resolution, problem-solving, and working with cross-functional teams.
• Preferred: Experience with external benchmarking and networking to identify improvement opportunities.

Education

• Bachelor's degree in biochemistry, chemistry, virology, biology, or a science-related field.
• Master‚Äôs or PhD in biochemistry, chemistry, virology, biology, or a science-related field (preferred).