Senior Manager, Quality Systems and Compliance

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.

Position Summary

The Senior Manager, Quality Systems provides management of activities for site Quality Operations in accordance with BMS policies, standards, procedures and global cGMPs. The Senior Manager, Quality Systems is responsible for supervising the activities of Quality Systems, Vector Manufacturing Facility group, developing and maintaining a GMP compliant training program, leading a Quality Systems team that will ensure Document Management and GMP Training processes and standards align with Global and Regional Regulatory requirements, working proactively to identify and address any training or document control compliance issues, managing  and motivating QA team members, building trust and cultivating a collaborative environment, and overseeing team responsibilities and maintaining a state of compliance.

Key Responsibilities

• Oversees, supervises, coordinates, and prioritizes daily activities of the Quality Systems group.

• Assures job objectives are met on a timely basis.

• Coordinate and prioritize project deliverables (as applicable) of the Quality department.

• Creation of employee development plans, and oversight of functional area to assure adequate staffing.

• Coach and mentor subordinates in the areas of training, disciplinary action, problem solving, and professional growth.

• Provide support for activities using the electronic training and document repository systems.

• Review of SOPs, Work Practices and training materials as required. Performs supplemental investigations/projects as required by senior management.

• Ensure global Policies, Standards, SOPs and Work Practices associated with the Quality Systems are properly implemented and trained.

• Act as primary link to the Global Quality Systems team to ensure systems are properly designed and implemented to support drug supply.

• Provides local support to end users in the administration of the Quality Systems

• Perform gap assessments to identify process deficiencies, provide reports to document detailed findings and recommend potential solutions.

• Develops and Maintains Quality Metrics to monitor overall compliance.

• Collaborates with process owners to develop appropriate actions to resolve quality system issues

• Responsible for developing, managing, and communicating training requirements as well as management of new hire training.

• Administer and maintain cGMP Training Program for department members.

• Provide support and execution of cGMP training needs and is primarily responsible for coordinating on-boarding and qualification activities for new employees based on established curriculum.

• Ensure compliance with regulatory and corporate training requirements.

• Collaborates and communicates with the Global QA Learning group and Document Control Group to ensure materials are compliant with cGMP requirements.

EDUCATION AND EXPERIENCE:

• Minimum 7 to 10 years relevant work experience and minimum 4 years of leadership experience. Relevant college or university degree preferred. Equivalent combination of education and experience acceptable.

• Experience developing and maintaining GMP Quality Systems and training programs required.

• Must have expert GMP Compliance, Product Quality, and in-depth Risk Management knowledge.

• Ability to effectively prepare communications to identify potential problems to management and the group with clarity and a high level of accuracy.

• Provide guidance to other employees in th