Sr. Manager, GMP/GDP Audits

工作内容

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The GMP/GDP audits team is responsible for GMP and GDP audits across the BMS network (both for Commercial and Clinical trial products).

This position is responsible for providing support to and management of the BMS GMP/GDP Audit Program for Global Suppliers (CMOs, API, External Labs, Compounding Facilities, Labeling facilities, Cell Therapy product manufacturers etc.) and BMS Internal Sites, as defined in BMS (GPS) Policies and Directives. The BMS GMP/GDP Senior Audits Manager works collaboratively with stakeholders to organize and conduct effective audits of Global Suppliers and Internal Sites, both clinical and commercial.

Responsibilities Will Include

• Plan, organize and conduct audits according the defined audit program.
• Support the clinical and commercial business development/acquisitions by performing unplanned and due diligence audits as requested.
• Lead and Execute audits of critical and non-critical suppliers both clinical and commercial.
• Lead and execute Mock Pre-Approval Inspections and Initial Audits
• Ensure 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.
• Implementation and execution of an effective risk based audit program globally, which bases frequency and scope of audits on risk.
• Lead and drive continuous improvement in Global Suppliers (CMOs, API, External Labs, Compounding Facilities, Labeling facilities, Cell Therapy product manufacturers etc.) quality and broader supplier management through collaboration with stakeholders – ultimately reducing risk and improving performance.
• Highlight risks & trends from the global audit program to management and take action as necessary; with metrics in place, routine communication and escalation mechanisms.
• Ensure alignment across the audit program and standardized processes and procedures.
• Collaborate and partner with stakeholders on strategic supplier initiatives.
• Simplify work through Continuous Improvement.
• Assure exceptions to the Master Audit Plan are properly documented and approved.
• Support CAPA closure as requested and ensure that audits are closed in the relevant management system.
  

Basic Qualifications

B.S. degree in a science or biopharmaceutical-related field.

10+ years’ experience in the Biopharmaceutical Industry

Preferred Qualifications

• Experience in Microbiology/Aseptic, Biologics DS, Cell Therapy preferred
• 5+ years in a GMP/GDP independent auditing role.
• Demonstrated auditor experience interacting with global vendors, suppliers and CMOs.
• Direct experience leading and conducting GMP/GDP audits and pre-approval inspections of Drug substance, Drug product, Biologics or Medical Device facilities.
• Demonstrated technical writing and communication experience for detailed audit reports, investigation and summary reports.
• Significant experience and technical knowledge in three or more of the following areas: Biopharmaceutical Manufacturing, Quality Assurance, Validation, Quality Control, Biotechnology, Facility & Utilities, Materials Management.
  

Travel Required

Up to 50 % travel time required per year to any region (Americas, Europe, Asia, etc.)

BMS BL

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

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

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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