QA Manager

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.

PDQ Functional Area Description

PDQ serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures. Key responsibilities include: drug substance and drug product batch disposition (release/reject decision), product certification and release by the EU Qualified Person, and audit of internal GMP systems/processes and suppliers/third party contractors, as well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections.

Principal Objective of the Position

Perform specific quality related functions to ensure facilities, utilities, equipment (including instruments and computerized systems) used in the manufacture, processing, testing, inspection, packaging, labeling, holding, storage, release, and distribution of Active Pharmaceutical Ingredient (API) or Investigational Medicinal Product (IMP) intended for investigational and registrational purposes are commissioned, qualified, validated, and maintained in compliance with applicable cGMP regulations and BMS standards.

Key Responsibilities and Major Duties

Perform independent review and approval of initial commissioning, qualification, and validation lifestyle documents and subsequent changes.

Review and approval of periodic re-qualification assessments.

Review and approval of retirement and decommissioning plans, protocols and summary reports.

Review and approval of documentation related to change control.

Review documents related to Quality Systems such as SOPs.

Review Validation Master Plans (i.e. site, department and functional area/building)

Provide instruction and guidance on quality issues during regulatory agency inspections, deviations, and CAPA discussions.

Participate in the Quality Agreement process for Contract Service Providers.

Provide reports to management related to timely CAPA implementation or other issues, as requested.

Participate in Vendor/Contractors Qualification activities, as requested.

If in a supervisory role, determines and coordinates the assignment of tasks to be carried out by the assigned Associates/Specialists.

Bring to the attention of management, any information relating to the impact of legislation on the functions of the department, system deviations, etc.

Adherence to BMS core behaviors

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Requirements

Degree/Certification/Licensure

University graduate (science degree preferred)

Experience – Responsibility and minimum number of years

Master of Science with 5 years experience or a Bachelor of Science with 7 years experience; including 5 years experience in regulated function.

Experience as a CQV, QA, and/or QC representative within Pharmaceutical/Drug Device Manufacturing (API, Sterile, Non-Sterile or Biological products) or Medical Device Manufacturing or Laboratory environment.

Working knowledge in the following:

Process Control Systems

Process Equipment and Utilities

Laboratory Equipment and Instrumentation

Packaging and Labeling Equipment

Environmental Monitoring Systems

Supply Chain Systems

Demonstrated knowledge and experience in cGMP regulations.

Strong Interpersonal and organizational skills.

Demonstrated leadership skills.

Excellent written and verbal communications.

Proficiency with MS Office Suite.

Travel Required (nature and frequency): Travel maybe be required from time to time, but will not exceed 10% of the time.

Describe exposure to any hazards/disagreeable conditions in the work environment: Employee will be occasionally exposed to GMP manufacturing environment, but all environmental safeguards will be implemented.

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