Bristol-Myers Squibb Company

GMP/GDP Audits Manager

Location
New Brunswick, NJ, US
Posted
Apr 14, 2018
Ref
R1505602
Required Education
Bachelors Degree
Position Type
Full time
This position is responsible for providing support to and management of the BMS GMP/GDP Audit Program to Global Suppliers (CMOs, API, External Labs, Compounding Facilities, Labeling facilities etc.) and BMS Internal Sites, as defined in BMS Policies and Directives.
The BMS GMP/GDP Audits Manager works collaboratively with ExM, R&D, GPS sites, MS&T and Global Procurement to strategically plan, organize and conduct effective audits to Global Suppliers and Internal Sites.

Key responsibilities
  • Plan, organize and conduct audits according the defined audit program.
  • Support the Integration of supplier auditing across clinical and commercial portfolios in conjunction with the External Audits Program Lead
    Specifically:
  • Execute audits of critical and non-critical suppliers both clinical and commercial.
  • Supports 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 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
  • Ensure alignment across the audit program and standardized processes and procedures, in partnership with Biologics & RDQ
  • Ensure all audit reports are issued & acceptable responses are received in a timely manner.
  • Ensure all audits are conducted against plan, reports are issued and acceptable responses are received. Take corrective actions when any of these documents are missing or late.
  • Support and Partner with PD, Global Procurement, MS&T and Sites on strategic supplier initiatives
  • Manage strategic projects and incorporate Lean/OpEx methodologies
  • Simplify work through Continuous Improvement
  • 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.
  • Assure exceptions to the Master Audit Plan are properly documented and approved.
  • Assure CAPAs are completed as scheduled and audits are closed in either AVID or SAMT.
  • Alert upper management and stakeholder organizations of potential compliance issues, like refused audits or critical/repeat observations. Have metrics in place with routine communication and escalation mechanisms
  • Obtain support from PD & 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 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. Ensure HA inspection readiness at all times at sites and Corporate level
  • Support standardization of practices and procedures and harmonize audit programs
  • Support the implementation of the GMP Auditor Qualification Procedure.
  • Support other duties as required.
    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 a Quality, Compliance, Technical, or Regulatory position, and least 5 years in a GMP/GDP independent auditing role.

    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.
  • Thinks clearly and 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.
  • Excellent oral and written communication skills
  • 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 required per year to any region (Americas, Europe, Asia, etc.).