Associate Director, Supplier Quality and Audits

17 hours ago

Fort Devens, United States Bristol-Myers Squibb Full time
Transforming Patients' Lives through Science

Bristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Associate Director, Supplier Quality and Audits to join our team.

About the Role

This is a critical role that will support the external supplier audit program and serve as a Subject Matter Expert (SME) for Supplier qualification/Approval for the site. The incumbent will also serve as the SME for the annual supplier Risk Assessment.

Key Responsibilities
  • Support the external supplier audit program as a team member and/or lead auditor.
  • Ensure suppliers are qualified and conduct audits at defined frequencies as part of the supplier monitoring process.
  • Schedule and coordinate external supplier audits to support BMS global supply network.
  • Coordinate and manage the Audit Information Request Forms (AIRF) prior to conducting audits and gather inputs from impacted sites.
  • Supports as the SME for the annual supplier Risk Assessment.
  • Author and maintain external audit schedule for the Devens Site.
  • Evaluate finding responses, track responses and follow up on actions to closure.
  • Supports and participates in regulatory agency inspections and corporate audits.
  • Review, communicate and track audit findings across the network.
  • Create, review, approve, and track corrective actions related to external audits.
  • Support the review, discussion and approval of Quality Agreements for external suppliers.
  • Participate on supplier business reviews, provide input for the topics that relate to supplier performance and audits outcome.
  • Support site activities that relate to the supplier change notification program and supplier complaint management program.
  • Support Vendor Qualification & Management Process with responsibility to ensure alignment with global policies and procedures.
  • Participates in and serves as Devens representative at Communities of Practice meetings.
Requirements

We are looking for a candidate with a strong background in biopharmaceutical quality, auditing experience in auditing quality systems, and knowledge of US and EU cGMP regulations and guidance. The ideal candidate will have a minimum of 10 years' experience in biopharmaceutical quality and will be certified in external audit (ASQ or otherwise). Knowledge of Veeva and SAP is highly desirable.

What We Offer

Bristol Myers Squibb offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment that values and respects the contributions of all employees.

We are an equal opportunity employer and welcome applications from qualified candidates from diverse backgrounds. If you are passionate about transforming patients' lives through science, we encourage you to apply for this exciting opportunity.

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