Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for Associate Director, Integrated Quality Plan Lead - BioResearch Quality & Compliance; Quality Planning & Strategy (QP&S) (3 positions) to be based at a Janssen Facility within the United States.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Integrated Quality Plan Lead will drive enhanced compliance through risk management and quality planning across specific Therapeutic Areas (TA) / Disease Area Stronghold (DAS) by partnering with relevant business partners. Under the management of the QP&S Therapeutic Area Head, the Integrated Quality Plan Lead is responsible for the development and execution of strategies designed to proactively mitigate R&D risks, such that the functions, processes and systems, and deliverables within R&D are compliant to Health Authority, industry and company standards and regulations.
Main responsibilities will include, but are not limited to:
- Develop and manage integrated quality plan (IQP) and create holistic approach to program and trial management oversight
- Develop and manage quality oversight strategies and programs that ensure for the responsible therapeutic areas that risks are identified and mitigated early (proactively mitigating issues), such that the functions, processes and systems and deliverables are compliant to Health Authority, industry and company standards and regulations.
- Support and provide input to the overall resource allocation of QP&S and QA resources for the applicable quality oversight plans
- Coordinate and perform periodic trending analysis on key metrics associated with quality oversight plans, and provide insights and analysis to business stakeholders, including senior management.
- In collaboration with Janssen Regulatory Compliance, manage Site Inspections as well as Sponsor Monitor Inspections. Support inspections managed by Regulatory Compliance and provide input to inspection strategies.
- Monitor issues and escalation initiated by Janssen QA or QP&S Trial Oversight personnel. Reconcile signals with the risks identified in the integrated quality oversight plans. Support issue management and escalation as necessary.
- Provide input as a subject matter expert on quality and compliance questions, and initiatives and projects pertaining to GCP arena.
- Leverage quality analytics data and contextualize key quality insights to primary stakeholders and provide quality consultancy.
- A minimum of a Bachelor of Science (BSc) degree in a life science, natural science or business is required.
- An advanced degree (MD, PhD, MSc, or PharmD) would be desirable.
- 10 years’ experience in the pharmaceutical or related industry in an applicable compliance field and/or the equivalent time and training/experience in a related R&D area (GxP regulated discipline) is required.
- Knowledge of the global drug development process, including current GxP policy and regulations is required
- Good knowledge of quality and risk management terminology and proficient knowledge of scientific terminology is required.
- Strong analytical skills & experience with implementation of new concepts is required.
- Strong experience in strategy design and execution during project leadership is required.
- Experience in Cardiovascular, Neuroscience, Infectious diseases, vaccines and/or Immunology is preferred.
- Experience in project management, change management, and leadership is preferred.
- Experience working in a matrix environment is preferred.
- Must be a problem solver, proactive strategic thinker, strong leader and collaborator.
- Strong written, visual, verbal communications with peers, business partners & senior management.
- Excellent organization, prioritization and time management skills.
- Ability to build consensus, influence and negotiate.
- Ability to navigate relationships and tasks with diplomacy and tact.
- Experience in synthesizing information and providing key insights to promote quality objectives
- Strong blend of both strategic and tactical approaches to quality and business objectives
- Ability to drive results through credibility, influence and leadership by example.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
United States-New Jersey-RaritanOther Locations
North America-United StatesOrganization
Janssen Research & Development, LLC. (6084)Job Function