What are the responsibilities and job description for the Senior Manager, Quality Systems and Compliance position at Bristol Myers Squibb?
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 the interpretation of compliance and technical/scientific issues across a majority of the job function. Develop employees and coach them to bridge knowledge gaps.
Strong authorship and able to critically review reports while effectively providing input and expressing Quality Risk management principles.
Action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity.
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 highly 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 completes 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.
#BMSCart, #LI-Hybrid
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
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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