Supplier Quality Manager - The Fountain Group

The Fountain Group is currently seeking a ­­­­­­­­Supplier Quality Manager for a prominent client of ours. This position is located in South San Francisco, CA. Details for the position are as follows:

Pay Range: $70-100+/hr
Contract: 1 year with possible extension or conversion
100% onsite

Job Description:

• Provide quality expertise and compliance oversight for GMP suppliers such as Contract Development Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) for the delivery of company products including bulk drug substance, bulk drug product and finished goods. Contribute as a key member of GMP supplier cross-functional management teams to select, implement and manage these suppliers.
• Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), such as due diligence and/or company audit assessments, risk assessments, complex investigations, and complaints. Develop, negotiate and maintain Quality Agreements and Product Specific Requirements with GxP suppliers, and ensure compliance with agreements.
• Collaborate with GMP suppliers to address any gaps in audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and timeliness with the supplier; and escalate as appropriate. Apply phase appropriate cGMP as the Quality Point of Contact on product development teams for a variety of platforms, such as large molecule, small molecule, conjugates, and oligonucleotides.
• Support internal cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures.

Qualifications:

• Bachelor's degree or higher
• CMO/CDMO/supplier management experience
• 6+ years working in a GxP pharmaceutical or biotechnology industry

If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at 813-356-0199.

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.