Change Control 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.

Summary:

• Manage the development change control program in support of the manufacturing and the laboratory areas of Product Development Operations (PDO).

• Serve as the compliance subject matter expert on change control at operations and project team meetings, as well as lead standing change control committee meetings.

• Manage the review and approval process for change control. Lead process and system improvements.

• Responsible for the continued monitoring of change control program and system to ensure that Product Development Quality (PDQ) and PDO comply with industry and BMS quality standards.

Responsibilities:

Provide continual oversight for the development change control program to promote compliance, consistency and operating efficiencies across PDQ and PDO. Ensure compliance to applicable Quality Policies, Directives, SOPs, agency guidelines and cGMP practices.

Serve as a champion for the development change control program ensuring alignment of functional area subject matter experts and key stakeholders and initiate and facilitate resolution of issues.

Lead the change control program by performing compliance review and approval of changes pertaining to GMP processes, methods, facilities, utilities, equipment, and associated computer systems.

Lead cross functional change control system improvements to ensure alignment to the overall change control strategy and process.

Monitors and trends change controls to ensure compliance with cGMP regulations and BMS procedures.

Provides training, instruction and guidance on change controls and serves as a resource for the development sites.

Develop and provide metric reports on change controls on a periodic basis.

Supports site operations during regulatory agency and third party inspections.

Perform other duties as assigned in support of PDQ and PDO.

Qualifications:

Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy or biology or a related pharmaceutical science

Minimum of 9-11 years experience in pharmaceutical quality and/or operations at a site level, including 3-5 years experience in a regulated function.

Experience within a QA/QC environment is an asset

Broad experience in the change control process and regulatory requirements

In-depth knowledge of GMP regulations

Strong problem solving, interpersonal and organizational skills

Strong collaborative and influencing skills

Effective written and verbal communication

Computer literacy: Microsoft Office and SAP environment Trackwise®, PDLIMs, and other systems as required (eg DeltaV)

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