Associate Director, Vendor Audits

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Reporting to the Senior Director, Competitive Compliance, the Associate Director, Vendor Audits, manages the relationship with the third-party service provider conducting audits for BMS. The Associate Director also acts as a liaison with External Manufacturing, the GMP/GDP audit team, and Predictive Quality to align audit plans and governance with risk-based principles, collaborating on risk mitigation strategies to ensure compliance.

• Manage the relationship with and oversee the third-party service provider conducting audits of external parties for BMS, including routine GMP/GDP audits, for-cause and preliminary evaluation audits of raw material, product and service providers.
• Act as the primary point of contact for the third-party service provider concerning quality and compliance issues, conduct periodic strategy review meetings, manage escalations, review audit dashboards, and collaborate to resolve any quality-related concerns or issues.
• Ensure the third-party service provider\'s audit reports, findings, and action plans adhere to BMS quality standards and to both global and local regulatory requirements.
• Identify opportunities for process improvements within the third-party service provider audit and management program, and implement best practices and innovative solutions to enhance the efficiency and effectiveness of the program.
• Act as the liaison with External Manufacturing and the GMP/GDP Audit Team, ensuring the global GMP/GDP audit plan and governance is logical, effective, and aligned with risk-based principles. Accurately identify and assess inherent risks to ensure a thorough evaluation of potential issues throughout the audit process.
• Ensure appropriate rigor and governance of critical suppliers as it relates to the audit program.
• Partner with the Predictive Quality team to gain insights into potential risks associated with contract manufacturing organizations (CMOs). Collaborate with External Manufacturing to develop and implement strategies that mitigate these identified risks, ensuring continuous improvement and reliability of manufacturing processes.
• Alert upper management and stakeholder organizations of potential compliance issues, like refused audits or critical/repeat observations in a timely manner.
• Utilize automation and predictive analysis tools to monitor industry trends and stay updated on evolving regulations, ensuring compliance, enabling the identification and prediction of potential risks.
• Plan, organize and conduct audits to the defined global GMP/GDP audit program, as required.
• Partner with Inspection Readiness in conducting mock pre-approval inspections (PAIs) at CMOs.

• Bachelor's degree in Natural Science, Pharmacy, or related fields, required.
• A minimum of eight (8) years' experience in the Biopharm/Pharmaceutical industry with in-depth knowledge and experience in global auditing procedures and best practices.
• Demonstrated negotiation, risk management, relationship management and conflict resolution skills.
• Proven ability to understand complex processes/problems and propose alternate solutions.
• Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
• Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Able to complete multiple, simultaneous projects with minimal supervision and prioritize incoming work appropriately.
• Has a proven track record of working across the network to find common solutions and drive positive impact and benefits for patients.
• In-depth knowledge of Global Health Authority regulations, quality systems principles and applications to the pharmaceutical industry.
• Ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)
• Proficiency in gathering insights from data analytics and advanced analytics tools.

• Mid-Senior level

• Full-time

• Accounting/Auditing and Finance

• Pharmaceutical Manufacturing

On-site/Work model and equal opportunity statements are described in the full posting. All other content has been preserved to reflect the original job description intent.