Director GMP/GDP Audit, Inspection Readiness

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 rich in diversity. 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. Read more: careers.bms.com/working-with-us

Responsibilities:

The position reports to the Sr. Director GMP/GDP Audit. Responsibilities for this position include, but are not limited to the following:

• Partners with GMP/GDP Audit and cross functional enterprise leaders to establish and manage a robust, risk-based process for inspection readiness.
• Works in conjunction with the Director, GMP/GDP Audit Planning, Risk Management, Training & Development ensuring that inspection preparedness activities are adequately resourced and included in the most current GMP/GDP Audit Plan.
• Develops robust metrics that measure the performance of the inspection readiness program and measure the overall inspection preparedness of the BMS Network.
• Works collaboratively with the Audits/Inspections GPO and Site Compliance Leaders to develop and maintain templates and tools that can be used to assist sites in managing inspections (e.g., remote inspection playbook)
• Provide on-site and remote inspection support as needed.
• Maintain Provides inspection readiness training when needed.
• Conducts inspection readiness assessments, and when necessary GMP/GDP audits as follows:

• Supports the clinical and commercial business development/acquisitions by performing unplanned and due diligence audits as requested.
• Leads and executes audits of internal sites and critical commercial and clinical suppliers.
• Ensures all audits are conducted against plan, generate written audit reports and distribute to applicable organizations. Evaluate audit responses and when necessary, request additional actions and clarification for the CAPAs submitted by the auditee.

• Performs all responsibilities in accordance with applicable company guidelines, SOPs and appropriate industry and regulatory standards, guidelines, rules, and regulations.
• Stays abreast of current and updated regulations affecting the supplier audit program. Make modifications to the program and Policies and directives to ensure an appropriate level of compliance with changing regulatory requirements. Facilitate HA inspection readiness at all times at the site and Corporate levels.
• Supports other duties as required.
• Adheres to BMS core values.

Requirements:

• B.S. or Advanced Degree in a science or biopharmaceutical-related field.
• Minimum of 15-years’ experience in the Biopharmaceutical Industry preferably in a Quality or Compliance, Technical, or a Regulatory position or a position within Regulatory Health Authority Agency. Some operational experience preferred.
• Minimum of 5-years of experience in a leadership role
• Has routinely participated in GMP regulatory inspections as a strategist, front room, or back-room lead.
• Proven ability to collaborate and influence across matrix global teams
• Strong understanding of current GMP/GDP regulatory expectations, and how to influence a positive outcome to regulatory inspections.
• Strong demonstrated strategic thinking and project management/ coordination skills.
• Ability to provide innovative solutions to an ever-changing regulatory environment
• Demonstrated people management experience
• Demonstrated writing experience for detailed investigation and summary reports
• Strong negotiation and conflict resolution skills
• Demonstrated understanding of or ability to apply risk-based principles to drive continuous improvement.
• Communicates effectively with different levels and can tailor the conversation to the target audience while maintaining a high-level of emotional intelligence especially in challenging discussions, and influences change
• Significant experience and technical knowledge in all the following areas: Pharmaceutical Manufacturing, Quality Assurance, Validation, Quality Control, Biotechnology, Regulatory Affairs, Research and Development, Facility and Systems Design, and Information Systems Technology
• In-depth knowledge of quality systems principles and applications to the biopharmaceutical industry, including Quality Risk Management principles
• Highly developed conceptual and analytical skills that support the ability to audit, investigate, and advise on problem resolution across a wide variety of quality/operational processes and practices
• Demonstrated ability to work independently or with groups of people/teams in a complex changing environment
• Up to 40% global travel required

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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