Associate Director, Cell Therapy Training, Quality Systems & Compliance
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.
Bristol Myers Squibb is seeking an Associate Director, Quality Training, Systems & Compliance across the Cell Therapy Organization Training Network. This role will be responsible for supporting the governance, strategy and sustainability for Quality Training, Systems and Compliance in accordance with BMS policies, standards, procedures and Global cGMPs.
This role will be interacting and supporting Cell Therapy Operations Training from a Quality Systems and Compliance perspective. Specifically, partnering with different functions (i.e. QC, QA, Operations, Supply Chain, MS&T) to drive Quality System Integration, measure, monitor and drive Quality System performance.
The Associate Director role reports to the Director, Cell Therapy Operations Training.
- Maintain the training program strategy in accordance with business needs, regulatory requirements, and Quality Management System.
- Provide guidance and subject matter expertise on necessary Learning Management and Quality Systems.
- Develops and Maintains Quality Metrics to monitor compliance.
- Collaborates with stakeholders to develop appropriate actions to resolve quality system issues.
- Act as primary link to other CTDO sites to ensure Quality Training & systems are properly implemented and consistent.
- Manage projects and training initiatives which directly support network and GxP initiatives, to effectively implement strategic business objectives in driving quality, compliance, and safety.
- Support policy and procedural changes to improve the quality of the Cell Therapy Organization Training Network, to include scheduled review of all existing documentation, guidelines, and materials. Evaluate and report on effectiveness of the changes.
- Ensure regulatory compliance expectations are always met.
- Provide SME support during internal and health authority inspections of facility including management of back-room.
- Collaborate, coordinate, and communicate across disciplines and departments.
Qualifications and Education Requirements
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
- 5-8 years of related pharmaceutical technical training experience preferably in a CAR-T production environment, QA, and/or QC related role required.
- Candidate must be familiar with and be able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMA, etc. Experience with Cell Therapy specific regulations highly desirable.
- Experience using ELMS and eLearning tools.
- Demonstrated leadership, communication, and motivation skills.
- Must be skilled in coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
- Demonstrated ability to coordinate across all functions. Integrate all aspects of business including negotiation of scope, roles and responsibilities, specifications, timelines, and resources across the organization.
- Strong interpersonal skills and the ability to apply these within a global, matrix organization (i.e., relationship building, listening, negotiation, and conflict management).
- Ability to manage change positively and sees change as an opportunity to improve processes and tools.
- Excellent communication skills. Demonstrated ability to write clearly and concisely.
- Ability to balance multiple assignments in a fast-paced environment.
- Ability to lead and direct change via influence rather than direct control.
- Ability to drive collaborations across functions to accomplish objectives.
- Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact team.
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.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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