Bristol-Myers Squibb Company

GMP/GDP Audits Manager

Location
New Brunswick, NJ, US
Posted
Jun 11, 2018
Ref
1R1505602
Required Education
Bachelors Degree
Position Type
Full time
Job Description

This is intended to be a general job description and should not be considered as all inclusive.

Professional experience and qualifications

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

Additional professional and personal requirements include:

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. 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. 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.).

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, AVID or SAMT. Alert upper management and stakeholder organizations of potential compliance issues, like refused 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 GMP Auditor Qualification Procedure. Support other duties as required. Adhere to BMS core behaviors.

As part of the GMP/GDP Audits Team, under the BMS (GPS) Integrated Global Quality, 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 etc.) and BMS Internal Sites, as defined in BMS (GPS) Policies and Directives.

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.

Key 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.