Sr. Manager Quality Systems (BPO CAPA)

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Title:

Senior Manager, Quality Systems CAPA Business Process Owner (BPO)

Location:

Summit West, S-12

PURPOSE AND SCOPE OF POSITION:

The Quality Systems Sr. Manager, Business Process Owner (BPO) for CAPA. QMS oversight of the CAPA 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 BPO is a recognized Subject Matter Expert within the group, providing advice cross-functionally to other areas. In addition, 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 BPO for Investigations QS is responsible for the establishment, maintenance, and continuous improvement of the Deviation and CAPA process, procedures, 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 leader that has developed high performing, independent and capable teams.
• 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; minimum 3 years of leadership experience including management of direct reports (for People Managers).
• 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.

This is the end of the Official Use document

REFERENCES AND ASSOCIATED DOCUMENTS:

WP-010288 S12 Job Description Process

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

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

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