Compliance Manager

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.

Compliance Manager: Analytical Quality and Compliance

Summary

Quality Assurance (QA) review and approval of technical documents pertaining to analytics ranging from early clinical development through and including commercial products. Technical document types include analytical method procedures, method validation protocols and reports, method transfer protocols and reports, reference standard qualification protocols and reports, Certificates of Analysis (CoA), other general procedural documents.

This QA role will collaborate with analytical functional areas to resolve associated deviations and other exceptional conditions as well as to assist with CAPA identification, management and resolution.

Details

• Perform the QA review/approval of technical documentation, including, but not limited to:
  • Analytical method validation protocols and reports for in-process and release/stability testing
  • Analytical method procedures and associated change controls
  • Method technical transfer protocols and reports
  • Reference materials and critical reagents
  • Standard Operating Procedures and other guidance documents
• Collaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations/exceptional conditions related to method validations, technical transfers or reference standard/critical reagent qualifications
• Collaborate with manufacturing support functions to develop the methods and acceptance criteria for the development of raw material specifications in preparation for Process Performance Qualification activities
• Assist in the development and authoring of procedural and other guidance documents for QA functions in Analytical Quality and Compliance

Required Qualification(s) and Desired Experience

• BS/BA in a life science field
• Minimum of 8 years of experience in the pharmaceutical industry with a strong background in the analysis of small molecules from a development or QC perspective
• Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the evaluation of technical documents for analytical methods and reference materials
• Excellent communication, relationship-management, negotiation and problem-solving skills
• Capable of managing multiple priorities and rapidly adapting to changing environment and circumstances
• Knowledge of solid dosage forms, parenteral technology, particularly in the small molecules area
• Knowledgeable in the development, content and authoring of standard operating procedures and other guidance documents
• Proficiency with the use of quality management systems
• Knowledge of program management tools and techniques is highly desirable
• Knowledge and experience with analytical methodology and compliance in the biologics area is a plus

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.