Director, GMP And GDP Audits

Director, Gmp And Gdp Audits

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Position Summary Reporting to the Senior Director, Competitive Compliance, the Director, GMP and GDP Audits is responsible for developing and implementing a strategic global audit program to proactively identify risk areas while aligning with company objectives and regulatory requirements. They will lead and mentor a team of auditors, ensuring their continuous development and adherence to industry regulations and best practices. This role involves managing resources effectively, overseeing audit processes for internal and external sites, and leveraging technology to standardize audit reporting. The Director will collaborate with various departments and senior management, providing expert guidance on regulatory compliance and audit findings. Additionally, they will focus on continuous improvement by identifying process enhancements and ensuring the effectiveness of training programs for auditors and stakeholders.

Key Responsibilities:

• Integrate the global perspectives to achieve the optimal audit strategy in accordance with company objectives to proactively identify risk areas.
• Lead, mentor, and develop a team of GMP/GDP auditors, fostering a culture of continuous improvement and professional growth.
• Manage and re-direct resources as necessary to assure that the company strategy and objectives are achieved.
• Oversee the training, performance evaluation, and continuous development of GMP/GDP auditors.
• Implement and oversee a comprehensive GMP/GDP audit program for both internal and external sites, in alignment with regulatory requirements and company policies.
• In collaboration with Predictive Quality, ensure alignment and proper deployment of annual audit plan.
• Ensure timely and accurate reporting of audit findings and follow-up actions, leveraging technology and automation to standardize report writing and audit agendas.
• Provide expert guidance on regulatory requirements and ensure the audit program is aligned with BMS standards as well as global and local regulatory guidelines.
• Identify opportunities for process improvements within the audit program and implement best practices.
• In partnership with the Training team, develop and deliver training programs to enhance the knowledge and skills of the audit team, leveraging industry best practices and auditor qualification program.
• Monitor and evaluate the effectiveness of audit qualification program and training.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Supply Chain, and Regulatory Affairs, to ensure alignment and support for audit activities.
• Plan, organize and conduct audits to the defined global GMP/GDP audit program, as required.
• Communicate audit results, trends, and risks to senior management and provide recommendations for improvement.
• Alert upper management and stakeholder organizations of potential compliance issues, like refused audits or critical/repeat observations in a timely manner.
• Collaborate with industry colleagues through benchmarking of regulatory activities to establish a state-of-art program.
• Potentially support key regulatory agency inspections of high risk and impact to the company, including review of findings and providing input into BMS position on inspection responses.

Qualifications & Experience:

• Bachelor's degree in Natural Science, Pharmacy, or related fields, required.
• A minimum of ten (10) years' experience in the Biopharm/Pharmaceutical industry with in-depth knowledge and experience in global auditing procedures and best practices.
• A minimum of five (5) years leadership experience managing Audit teams.
• Demonstrated ability to lead and manage effective teams.
• 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.
• Strong communication, collaboration, negotiation, problem solving and interpersonal skills.
• 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.
• Proficiency in gaining insights from data analytics and advanced analytics tools.

The ideal candidate should have experience participating in Health Authority inspections and, preferably, have worked for a Health Authority such as the FDA or other health authority agencies.