Sr. Manager, Quality Systems (R1554764-en-us)
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.
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 Deviations and 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.
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.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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