Field Quality, QA Manufacturing Operations Manager

Working with Us
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.

Location: Devens, Massachusetts

Working with Us
Challenging. Meaningful. Life-changing. Those are not 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 will 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

Qualifications & Experience:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.

• A minimum of 8 years experience in biopharmaceutical quality, with a minimum of 2 years of management responsibility and 2 years of quality and compliance functions is preferred.

• Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.

• Knowledge of US and EU cGMP regulations and guidance.

• Knowledge of electronic systems including any of the following: SAP, LIMS, QMS, and electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.

• Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release.

• Knowledge and proven experience in FDA, EMA, or other regulatory authority.

• Knowledge in Operational Excellence and Continuous Improvement is desirable.

• Experience in building and growing an organization into a high performance team.

• Demonstrated leadership, interpersonal, communication, and motivation skills.

• Excellent writing and oral communication skills are required.

• Previous work responsibility, which required a high degree of attention to detail.

• Well practiced in exercising sound judgment in decision-making.

• Demonstrated multitasking and organization skills.

Key Responsibilities:

• Establish and communicates performance objectives for Quality Assurance staff that are consistent with the businesses unit goals, Quality and Technical Operations objectives. 

• Provide quality floor support of complex manufacturing issues

• Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.

• Hires, integrates and develops high quality talent, capable of delivering against the department’s goals and objectives.

• Provides quality oversight of manufacturing activities on a day to day basis

• Provides oversight of the review and approval of changes to master batch recipe records.

• Performs review and approval of site procedures and documents.