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. 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 Director, Clinical Supply Quality is a critical management position within the PD/R&D Quality organization that is responsible for the global regulatory compliance of our clinical supplies and oversight of clinical supply quality activities. The Director, Clinical Supply Quality is responsible for internal packaging at New Brunswick, global labelling operations, ISR studies, PAA/PSDA studies, IMP supply and management at sites. The position provides leadership for the identification and resolution of critical quality issues that may affect BMS. The Director, Clinical Supply Quality will act as Quality Culture ambassador across CSO, CSC, SQIMQ and GDO with responsibility for influencing senior leadership across BMS with respect to the importance of building continuous quality improvements into the organization. Reports to Senior Director, Clinical Supply Quality. Manages QA Operations personnel.
Key Responsibilities
Quality Culture ambassador to collaborate and influence across CSO, CSC, SCIMQ and GDO, with responsibility for influencing senior leadership across BMS with respect to the importance of building continuous quality improvements into the organization.
Authorized Person, responsible for the release of Investigational Medicinal Products in accordance with the requirements laid down in the Australian Government Therapeutic Goods Administration Guidance on Release for Supply.
Oversight/Disposition of Additional Labeling activities at warehouse level outside of EU QP Oversight (Collaborate with SCIMQ As appropriate).
Accountable for the global regulatory compliance of our clinical supplies and the resolution of any issues prior to certification by the QP team within the EU.
Accountable for GCP Health Authority inspections and audits at clinical sites.
Lead the CSCQ (SCIMQ)/CSQ LT meetings utilizing metrics and digital methods.
Lead Support for GCP inspections IMP agenda.
Lead Clinical Stock Recovery and Mock Stock Recovery.
Support NTM’s - Back Up to PDQ Lead.
Collaborate with SCIMQ for IMP Supply Management.
Oversees/provides compliance consultation to stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships.
Promotes high standards of quality, compliance, and process excellence through oversight of procedure development/enhancement as well as by leading or contributing to supportive initiatives to ensure delivery of business goals.
Incorporate global regulatory trends and changes into Clinical Supply Quality.
Engage with executive management and cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement.
Continually evaluate the strategic approach, drive changes in PDQ processes, and modify the PDQ program to meet the changing needs of the organization, regulatory environment and industry best practice.
Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products, to business partners and senior management.
Build and maintain a Clinical Supply Quality organization by creating an environment that attracts, develops and retain high-quality employees.
Develop hiring plans to staff critical areas in PD Quality and establish the necessary infrastructure to ensure alignment with corporate objectives.
Provide leadership, coaching, professional development, mentoring, and support for direct and indirect reports, including talent planning and performance management.
Develop, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key deliverables.
Engage and energize employees through communication of goals, priorities, and other business critical information as well as recognizing and celebrating success and achievements.
Attract high-caliber talent and facilitate functional talent development through coaching and provision of challenging assignments to promote individual and team development.
Lead performance management processes to ensure that individuals are held to appropriate, consistent standards and that key leadership development and succession plans are established.
Promote a high-performance, externally-focused operating culture throughout organization which emphasizes customer, teamwork, personal accountability, and commitment to quality.
Model desired behaviors personally and reinforce desired behaviors at all levels in organization.
Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline.
Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level.
May influence the external environment through interactions with regulators, trade associations, or professional societies.
Proactively identify risk areas - brings ideas and strategies to the forefront and has a firm grasp of the business needs.
Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.
Liaise with clients in R&D and Business Units to understand global and local needs and determine priorities.
Delegate for Senior Director, PDQ.
Travel: Local and international travel may be required up to 5-10% of the time.
Qualifications & Experience
Minimum of B.S. degree, preferably in chemistry, biochemistry, biology or a related pharmaceutical science.
13-15 years experience; including 5+ years experience in a regulated function.
A strong knowledge of country CTA requirements across the BMS footprint.
Experience in Quality Management at the development and/or commercial stage of pharmaceutical operations.
In-depth knowledge of cGMP and EU GMP regulations.
Strong problem solving, interpersonal and organizational skills.
Strong collaborative and influencing skills.
Effective written and verbal communication.
Strategic thinker with enterprise mindset.
Ability to develop team members.
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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.
Madison - Giralda - NJ - US: $188,250 - $228,114
New Brunswick - NJ - US: $188,250 - $228,114
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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 a supportive culture, promoting global participation 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 an 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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