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 Title:

Senior Manager, Quality Systems

Location:

Summit West, S-12

PURPOSE AND SCOPE OF POSITION:

The Quality Systems Sr. Manager, QMS oversight of the Quality Systems programs at the S-12 Summit, NJ site, in accordance with BMS policies, standards, procedures and Global cGMPs. The incumbent routinely recognizes and resolves Quality issues and compliance risks and informs management of decisions on complex issues. The incumbent is able to interpret complex results/situations independently, manage conflict/issues with internal/external multi-disciplinary teams and articulate recommendations for resolution. The incumbent plays a key role in providing expert guidance to multi-disciplinary teams and senior management, while recognizing risk, developing contingency plans, negotiating solutions cross-functionally, driving continuous improvement and improving efficiency/productivity within the group or project. For direct reports, the Investigations BPO works with employees to develop procedures, establishes goals and priorities for the department, develops/coach employees and contributes to succession planning and organizational design.

The Sr. Manager for QS is responsible for the establishment, maintenance, and continuous improvement of the QMS, and responsibilities for achieving quality policies and objectives. This organization supports the S-12 facility in Summit, NJ to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and group with clarity, brevity and accuracy.
• Strong authorship; able to critically review documentation and interpret data. Able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
• Minimum of 8+ years working in a Quality or Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.
• Detail oriented with strong knowledge of cGMP regulations, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy.
• Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
• Leads teams and cross-functional project teams and drives team performance and results. Contributes to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values.
• Requires minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
• Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
• Able to interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans.
• Drives continuous improvement and improves efficiency and productivity within the group or project.
• Critically assesses project(s) and allocates resources to efficiently achieve goals.

Education and Experience:

• Relevant college or university degree required
• Minimum 9 years relevant work experience;
• Equivalent combination of education and experience acceptable

DUTIES AND RESPONSIBILITIES

• Viewed as Subject Matter Expert;
• Provide guidance/coaching to direct reports (people managers);
• Act as site lead for Investigations. Fully support projects within project timelines
• Assures job objectives are met on a timely basis
• Coordinate and prioritize project deliverables (as applicable) of the Quality department
• Create 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 Deviation and CAPA management systems
• Review of SOPs, Work Practices and other types of documents as required. Performs supplemental investigations/projects as required by management.
• Ensure global Policies, Standards, SOPs and Work Practices associated with the CAPA processes are properly implemented
• Act as primary link to other CTDO sites to ensure Deviation and CAPA management process is properly implemented and consistent
• Oversees management of 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 compliance
• Collaborates with stakeholders to develop appropriate actions to resolve quality system issues
• Responsible for developing, managing, and on-boarding requirements for new staff within Document Control
• Provide SME support during internal and health authority inspections of facility, including management of back room.
• Lead integration projects.
• Lead site quality management reviews and Oversee KPIs for the QMS.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.