Quality Assurance Manager

Our client is looking for a Quality Assurance Manager. In this role you'll collaborate closely with external supply business lines and clinical product development teams to optimize the contributions of Global Quality Operations. As the Quality Assurance Manager, you'll oversee quality management for approximately 25 contract manufacturers, packagers, contract test laboratories, and supply partners worldwide. This Quality Assurance Manager involves independently negotiating, developing, and communicating Pfizer's quality requirements with contract vendors. This is a hybrid position requiring 2-3 days per week in office. The worksite is located near Romence Rd Pkwy and Portage Rd, in Portage, MI. 

Job Responsibilities:

• Provide guidance, lead or co-lead projects, and manage time effectively to meet objectives.
• Plan resource requirements for projects across the department.
• Contribute to Quality Assurance by undertaking various roles or assignments to enhance internal processes and capabilities.
• Assess supplier operations for adherence to regulatory requirements, Quality Agreement stipulations, and Pfizer's expectations.
• Conduct quality reviews and report findings or defined quality analytics to relevant stakeholders.
• Provide project support ensuring compliance with Good Manufacturing Practices (GMPs) in clinical supply packaging operations.
• Offer guidance on procedures and training necessary for full compliance with current GMPs.

Required Hard Skills:

·      5-7 years of Vendor Quality Management Experience in the Pharma industry.

·      Comprehensive understanding of cGMP.

·      Proficiency in project management.

·      Proficient in MS Office suite.

Plus Skills:

·      Strong relationship-building abilities.

·      Negotiation skills.

·      Auditing experience.

·      Familiarity with SAP.

·      Bachelor's degree preferred; open to candidates with 5 years of relevant experience in lieu of a degree.