Head, External Quality, Biologics Drug Substance


San Francisco, CA

What you'll be doing

Responsible leader for the management and execution of these activities by ensuring appropriate resources are available and assigned and appropriate priority assigned across PTB bulk drug substance CMO. Responsible for ensuring that all GMP activities are in the best interest of the patients, comply with global regulations and uphold company and Genentech reputation as a reliable, high quality supplier of products. In collaboration with all other PTx functions, regions and sites ensure appropriate measures are employed to fulfill the requirements of cGMPs and international standards, and requirements, as applicable. Responsible for management of risk, through proactive risk management tools and approaches. Ensure risks for company right to operate and quality supply of products to patients are minimized. Accountable for the management of quality and compliance across global PTB bulk drug substance CMO to include: organization design and implementation, leadership selection and staffing, talent management, performance management, financial budgeting and financial performance, execution to meet strategic and operational objectives.

What your background should be

International expert in quality and compliance principles, requirements and cGMPs. Minimum 15 years in pharmaceutical quality management leadership roles. Established track record of quality and compliance decision-making. Established track record of successful regulatory inspections. Demonstrated leadership and execution of quality operations and processes. Experience managing a network of operations. International experience. Experience in multiple technical drug substance platforms (large molecule proteins, small molecule chemical and anti-body drug conjugates).

Required Schooling / Training

BS degree. MS, PhD in microbiology, chemistry, biology engineering, or other life science preferred.

Who is the client company

This is a global health-care company that operates worldwide under two divisions: pharmaceuticals and diagnostics.
If you are interested in this position, send your resume to apply@kochdavis.com