Director RampD Lifecycle Management QMS Documentation and Activities - QMS

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Manage and lead team of procedural document (PD) managers, writing associates and PDHQ content managers to create and/or revise procedural documents in R&D and GPS. Procedural management activities include, but are not limited to, 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. In addition, this role will provide the overall program framework for milestone development, tracking and resource plan development and execution.

esponsibilities:

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 Excellenceacross 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 p rocesses, 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 makingchanges 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 regulat i ons and maintain an awareness of compl i ance i ssues

Recommend improvements to the PD management process on the bas i s of regu l atory needs, benchmarking, and opportunit i es for business process improvement

Work close l y with upper management to identify and work with key stakeholders to ensure that PDs are deve l oped in accordance with current practice and functional needs

Manage the PD Leads by providing guidance and d i rection on how to effectively develop PDs, meet goa l s and objectives and manage the Book of Work

Prepare presentations and other mater i als to effective l y represent the QS&LM department

Negotiate complex situat i ons w i thout direct author i ty

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

Required Knowledge/Skills/Qualifications

Education/Experience/Knowledge:

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.

Skills/Competencies:

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

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1522751_EN

Updated: 2020-03-10 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com