Manager Quality Operations

Description:

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Roles and Responsibilities:

• Perform batch documentation review to support product disposition activities of drug product and finished product that meet commercial customer requirements while ensuring compliance with testing standards, SOPs, validation guidelines and regulatory filings.

• Author, compile and maintain documentation needed for disposition of the product from Contract Manufacturing Organizations (CMOs)

• Review disposition documentation, escalating potential issues

• Ensure batch documentation relative to CMO materials and products is maintained and archived

• Evaluate external quality complaint investigations provided by CMOs

• Input required deviation, complaint, change control, and product disposition information into applicable enterprise systems

• Prepare and review of Quality Agreements with external manufacturers and external laboratories

• Assist in preparation of Annual Product reviews as required for end to end product monitoring

• Support / backup role of VPT QA representative to ensure coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships

• Provide support to specified quality and technical projects as they arise

Requirements:

• Minimum B.S. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science

• Significant experience in pharmaceutical operations in (external) manufacturing / QA operations role

• Experience in Quality - batch release function

• Accuracy and orientation to details

• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met.

• Good verbal, written and presentation skills in English

• Proficiency with the use of global systems (e.g. SAP, Microsoft Office)

• Strong strategic and analytical thinking, problem solving and rapid decision-making skills

• Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment

• Strong ability negotiating and influencing without authority in complex, high impact situations

• Demonstrated ability in technical writing, computer knowledge and communication skills is required

• Demonstrated technical expertise in resolution of deviations, development of effective CAPA and use of risk assessments