Locations : US (NJ/Philadelphia), Belgium (Beerse) or NL (Leiden)
+ Member of, and active participant in, the CMC RA SLT. Partners with other SLT members to ensure high performing organization and consistent application of practices, policies, systems and programs
+ Planning, organizing, and directing resources and activities within CMC RA
+ Coordination of selected initiatives within CMC RA / GRA
+ Supervise and provide leadership and oversight for CMC RA staff
+ Assures that appropriate objectives and metrics are established, monitored and met, including removing barriers
+ Responsible for training, coaching and development of the team members
+ Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Senior Management
+ Represents CMC RA on Cross Functional Governance Committees
+ Serves as a thought leader on internal and external teams to proactively influence Health Authority Policy and practice on CMC issues
+ Creates engagement and a culture of collaboration flexibility, and competitiveness by increasing business and scientific acumen, industry knowledge and skills
+ Enables a culture of performance driving a more flexible organization using levels as process improvement and innovation
+ Drive implementation of strategic plans
Sphere of Authority
+ Responsible for talent and development management strategy in line with the GRA strategy within his/her group
+ Design and embed efficient business processes and drive continuous improvement of working practices to maximize the efficiency of the CMC RA team.
+ Drive operational efficiencies and effectiveness for Global CMC RA that optimizes the department's capabilities and enhances overall quality, efficiency and productivity by ensuring systems are fit for purpose and utilized effectively.
+ Oversight of department data by ensuring process flows and job aids are developed, maintained and trained on and that data entry follow appropriate guidelines.
+ Identify and implement new tools and systems. Provide training and mentoring for the use of IT systems
+ Responsibility for the implementation and monitoring adherence to Guidance, Policies & Procedures applicable to CMC RA, produce monthly performance reports
+ Ensures global regulatory filings for development compounds and marketed products are supported with relevant C&S and country specific requirements in collaboration with CMC RA personnel and global teams.
+ BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 15 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent. An MS, Ph.D., or Pharm. D. degree preferred
+ Minimum of 5 years demonstrated leadership and people development skills within a regulatory function preferred
+ Successful experience in leading a diverse community of professionals in a global and matrix environment. Seasoned leader, decision maker and constructive challenger
+ Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is preferred
+ Proven track record and/or deep understanding in developing and implementing successful CMC regulatory lifecycle strategies and seen as an expert on product development and how it is applied to global regulatory strategy
+ Strong attention to detail with high-level verbal and written communication skills
+ Makes decisions based on facts and sound scientific principles
+ Ability to interact with all levels in the organization
+ Communicates cross-functionally and cross-company; presents and defends CMC management-approved regulatory strategy to project teams; recognizes and accounts for global regulatory impact
+ Demonstrates model behavior that understands what the priorities are and encourages others to drive for results
North America-United States-New Jersey, North America-United States-Pennsylvania-Philadelphia, Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Janssen Cilag N.V./S.A. (7025)
00002B Associated topics: analyst, endowment, festival, newspaper, policy, policies, presale, public, regulatory, social media
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.