Supplier Quality Manager

Exciting opportunity to join one of our top biotech clients, focusing in the Cell and Gene Therapy Space. We are looking for someone on an initial 6 month contract basis, with the scope to extend and potentially be made permanent. If you have extensive experience in Supplier Quality and working with CMO's in the Biologics, Cell & Gene Therapy space we would love to hear from you!

Responsibilities:

• Oversee both internal and external audit programs.
• Ensure compliance with the audit schedule and manage the logistics and timing of audits.
• Conduct audits in alignment with relevant regulations and guidelines.
• Assess audit responses and identify potential risks.
• Review supplier compliance with regulatory standards.
• Manage supplier questionnaires, including enhancing content, coordinating completion with suppliers, and assessing responses.
• Create quality agreement templates and define standard terms.
• Lead or facilitate negotiations for quality agreements.
• Conduct regular reviews of quality agreements.
• Assist in supplier qualification and monitoring processes.
• Engage in departmental and cross-functional process improvements and special projects as directed by management.
• Contribute to the development of supplier performance metrics.
• Perform other duties as needed.

Requirements:

• Bachelor's degree in Engineering, Chemistry, or Biological Sciences required.
• Advanced degree or ASQ Auditor/Quality Engineer certification preferred.
• Minimum of 10 years of experience in quality assurance, manufacturing, QC, or quality engineering.
• Experience in auditing and supplier qualification within the biopharmaceutical industry.
• Comprehensive knowledge of quality system requirements, including US FDA GMP, GCP, EMA, and ICH guidelines, with a proven track record of successful implementation.
• Strong interpersonal, verbal, and written communication skills essential for a collaborative work environment.
• Ability to thrive in a fast-paced, small company environment with minimal supervision and adapt to changing priorities.
• Excellent organizational skills and ability to prioritize tasks effectively to meet deadlines.
• Proficient in MS Word, Excel, PowerPoint, Visio, and Project.
• Familiarity with Veeva is advantageous but not required.
• Must be authorized to work in the US.
• Some travel may be necessary.

Please note - no C2C or Visa Sponsorship available.