Head Oncology Quality Planning and Strategy

仕事内容

Johnson & Johnson - Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India. Driven by a strong commitment to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and strives to empower people through disease awareness, education and access to quality care in six therapeutic areas.

Janssen Bio Research Quality and Compliance is recruiting for a Head Oncology, Quality Planning and Strategy, located in North America or Europe.

This position owns the development and management of oversight strategies and programs that ensures that issues are identified and mitigated early, such that the functions, processes and systems, and deliverables within clinical R&D are compliant to Health Authority, industry and standards and regulations. This leader will provide strategic quality consultation to key business partner by developing proactive quality support, real-time issue management, using analytics-based data and leveraging cross-therapeutic area expertise. The position is a key leader in the organization to developing future quality leaders, embedding a quality culture in the organization and transforming our capabilities into industry leading.

Key Responsibilities

• Drive the success of the long-term strategic plans for the R&D Oncology area through effective partnering with leaders across R&D functions. Provide a comprehensive and proactive assessment of quality/GCP compliance-related risks that may impact the safety of human subjects enrolled in clinical trials and/or our ability to meet strategic business objectives. Work with cross-functional partners to ensure efficient use of resources to mitigate risks proactively and address issues reactively that are considered significant.
• Coordinate the clinical R&D and operations units, including but not limited to proactive risk management, clinical trial issue management, CAPA oversight, and inspection management. Liaise with BRQC Janssen QA to ensure audit plans address significant risks and issues. Drive excellence in execution for trial oversight.
• Represent a broad BRQC Janssen perspective in key governance meetings where compounds are discussed. Ensure that risks identified or discussed in these meetings are appropriately brought together in risk management.
• Provides strategic leadership leading a team of QP&S employees in US and EU to ensure consistent quality oversight of the core business, business continuity, routine process improvement, and driving effective communication a. Attract, develop and guide an impactful team to support BRQC Janssen, Janssen Quality and JnJ Q&C visions.
  

Education

Qualifications

• A minimum of a Bachelor’s Degree is required
  

Experience And Skills

Required:

• A minimum of 15 years of related work experience in a medium- to large-scale, Life Sciences organization is required with strong GCP quality and/or clinical trials experience.
• Demonstrated experience engaging executive leaders and establishing customer relationships. Strong ability to influence a broad array of global Business partners. Proven understanding of worldwide clinical safety compliance regulations and guidelines, along with broad exposure to the array of regulatory and legal requirements within the life science industry. Confirmed capability making strategic use of quality/compliance data to supervise and raise performance.
• Responsible for making decisions regarding business issues, strategic support and organizational development, as required by business needs and organizational growth. The scope is across various R&D functions, and requires significant collaboration, alignment, and influencing.
• Strong networking and relationship building skills and ability to create an open and inviting environment.
• A proven track record of leading and developing people.
• Develops a learning organization, encourage experimentation, risk-tasking, and development in all aspects of work performance.
• Utilizes and encourages and shares innovative approaches to build and maintain a competitive advantage
  

Preferred:

• Advanced degree in Science or Business
• Strong GCP quality and/or clinical trials experience in Oncology
• Ability to create relationships with industry peers and to interact, as appropriate and as needed, with quality professionals in third-party organizations, marketing partners and health authority officials.
  

Other:

• Proficient in written and spoken English.
• Ability to travel 25%, domestic and global
• Proficiency with MS Office products (Word, Excel, PowerPoint, Outlook), MS Visio, and visual aid software
  

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (http://www.careers.jnj.com).

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Other Locations

Europe/Middle East/Africa-Netherlands-South Holland-Leiden, United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206079056W