Director, R&D Lifecycle Management QMS Documentation and Activities, QMS
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.
Manage and lead team of procedural document (PD) managers, writing associates and electronic system content managers to create and/or revise procedural documents in legacy Celgene, R&D and GPS. Procedural management activities include, but are not limited to, overseeing legacy Celgene Quality System documents, working with subject-matter experts to ensure accurate document content and compliance with health authority regulations and expectations. This role will also be responsible for supporting Lifecycle Management related activities. This role will ensure we are following a standard process and methodology driving process improvements and long-term sustainability as well as ensuring issues are appropriately escalated and mitigated.
Major Duties and Responsibilities
- Lead a (PD) team to solve complex problems, create deliverables and complete them in a timely manner
- Synthesize feedback from subject matter experts/ PD teams to identify and resolve issues in order to accurately document current and future PDs
- Ensure effectiveness of process-based QMS to improve Quality, inspection readiness, and drive Culture of Excellence across R&D and other divisions globally
- Develop and Deliver robust communication and tracking tools to enable transformation of the R&D QMS.
- Responsible to work with cross-functional leadership (across R&D and GPS) to advance the end-to-end QMS integration and continued optimization across the product lifecycle.
- Effectively manage projects, escalate issues as necessary and identify/meet key milestones
- Collaborate with appropriate Regulatory colleagues on changes to new or revised GXP/ICH Guidelines to manage the interpretation, communication, and implementation of applicable changes to clinical research
- Work with limited guidance to manage the development of PDs for key procedures, seeks input as needed.
- Assist in developing the vision and strategy for the QS&LM Department
- Participate in goal and objective setting for the department and oversees progress towards meeting objectives
- Lead and implement change initiatives to achieve continuous improvement in QS&LM processes, including how PDs are managed, updated, and drives change in the organization
- Identify and lead improvement efforts within the QS&LM group
- Exercise sound judgment, using a risk-based approach, to ensure compliance with PD regulations, practices, and policies.
- Coordinate with Functional leadership teams to enable role-based training deployment for E2E processes
- Accelerate resolution of issues with appropriate escalation in making changes to E2E processes, procedures, and training
- Identify and implement state-of-the-art business models and systems for PD management and continuous improvement
- Interpret regulations or contact appropriate resources regarding regulations and maintain an awareness of compliance issues
- Recommend improvements to the PD management process on the basis of regulatory needs, benchmarking, and opportunities for business process improvement
- Work closely with upper management to identify and work with key stakeholders to ensure that PDs are developed in accordance with current practice and functional needs
- Manage the PD Leads by providing guidance and direction on how to effectively develop PDs, meet goals and objectives and manage the Book of Work
- Prepare presentations and other materials to effectively represent the QS&LM department
- Negotiate complex situations without direct authority
- Lead department Lifecycle Management process optimization through cross functional teams as part of project Fusion to identify root causes of sub optimal process flow, identify gaps, help teams with process new or re-write phase.
- Champions and drives Lifecycle Management activities to meet Health Authority commitment deadlines
- PhD with 6-8 years’ experience working in a pharmaceutical or highly regulated environment, Master’s degree with 8-10 years’ experience or Bachelor’s degree with 10-12 years’ experience.
- Demonstrated influential leadership expertise and experience with senior level interactions and influence with Clinical Research, Clinical Operations, Global Quality and Regulatory functions.
- Demonstrated Enterprise mindset to be able to think and act across functions and divisions
- Demonstrated people management experience.
- Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
- Demonstrated ability to drive organizational change while balancing priorities utilizing strong organizational skills
- Exemplary leadership skills as demonstrated by the ability to manage individuals and teams towards meeting goals
- Ability to drive consensus, drive performance and to lead strategically.
- Demonstrated success in managing project, team effectiveness, facilitation and presentation skills
- Demonstrated knowledge of FDA regulations and ICH guidelines applicable to GXP. FDA regulations and ICH guidelines include, but are not limited to, the following: 21 CRF Parts 11, 58, 111, 210, 211, 610 and 820 and ICH Q7, Q8, Q9, and Q10
- High level of competency in PD writing including the appropriate use of grammar, syntax and organization of ideas
- Knowledge of project management concepts and strategies
- Knowledge of requirements for development, use and maintenance of controlled procedural documents
- Demonstrated ability to resolve complex issues and differences in a creative, constructive and diplomatic manner
- Demonstrated ability to work independently and mentor team members
- Demonstrated ability to maintain a high level of productivity, accountability and energy
- Proven teambuilding skills and an ability to foster partnerships across projects and multidisciplinary teams
- Demonstrated ability to follow up on open issues and drive results to completion
- Demonstrated ability to effectively and decisively establish appropriate priorities for self and matrix teams
- Proven track record for taking on challenges that are outside of normal book of work
- Strong communication skills
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.
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