GMP/GDP Audits Manager - Stratigic Planning

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

This position is responsible for providing support to and management of the BMS GM P/G DP Audit Program for Global Suppliers (CMOs, API, External Labs, Compounding Facilities, Labeling facilities etc.) and BMS Internal Sites, as defined in BMS (GPS) Policies and Directives. This position will play a role in the development and maintenance of the global audit plan and provide support the maintenance of the global audit plan in electronic system. The BMS GMP/GDP Audits Manager works collaboratively with ExM, R&D, GPS sites, MS&T and Global Procurement to organize and conduct effective audits of Global Suppliers and Internal Sites, both clinical and commercial.

Major Duties and Responsibilities

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.

Specifically:

Execute audits of critical and non-critical suppliers both clinical and commercial.

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.

Support 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 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.

Support alignment across the audit program and standardized processes and procedures.

Support and Partner with R&D, Global Procurement, MS&T and Sites on strategic supplier initiatives.

Simplify work through Continuous Improvement.

Assure exceptions to the Master Audit Plan are properly documented and approved.

Assure CAPAs are completed as scheduled and audits are closed in either TrackWise, Infinity or SAMT.

Alert upper management and stakeholder organizations of potential compliance issues, like ref used audits or critical/repeat observations.

Obtain support from R&D and Global Procurement to deal with suppliers with quality issues. These

Quality issues include, but are not limited to, audit refusal, audit fee, inappropriate audit responses or no audit responses.

Provide support to Global Quality in the form of assistance to the internal audit program, regulatory audits, and other related projects as assigned.

Perform all responsibilities in accordance with applicable company guidelines, SOPs and appropriate industry and regulatory standards, guidelines, rules and regulations.

Stay abreast of current and updated regulations impacting 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.

Support standardization of practices and procedures and harmonize of audit programs/ activities.

Support the implementation of the GM P Auditor Qualification Procedure.

Support other duties as required.

Required Knowledge/Skills/Qualifications:

Education:

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

Minimum of 10 years' experience in the Biopharmaceutical Industry preferably in R&D, with deep knowledge in Microbiology/Aseptic and

Biologics OS, and > 5 years in a GMP/GDP independent auditing role. The ideal candidate has worked in a Health Authority.

Experience/Knowledge:

Demonstrated auditor experience interacting with global vendors, suppliers and CMOs.

Direct experience leading and conducting GM P/G DP 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.

Skills/Competencies:

Ability to think clearly and act in a decisive manner; communicate difficult observations in a calm and cogent manner.

Demonstrated ability to work independently or with groups of people/teams in a complex changing environment.

Adaptable/flexible and able to deal with change. o Enterprise mindset and external focus.

Demonstrated negotiation, risk management, relationship management and conflict resolution skills.

In-depth knowledge of Global HA regulations, quality systems principles and applications to the pharmaceutical industry.

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.

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

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com