Director QA Preclin Functional Mgmnt

Key Skills

Data science techniques, Leadership Skill, Management, Operations, Planning and organization, Teamwork

Job Description

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us at @JanssenGlobal.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Janssen’s culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

Janssen Research & Development, L.L.C. has an exciting opportunity for a motivated global people leader with experience in Preclinical Quality Assurance! The Director, Preclinical QA Functional Management, is a new strategic role in the R&D Quality Preclinical QA Domain that drives the implementation of a proactive risk management program and the development and execution of a global Preclinical audit strategy to ensure Janssen Pharmaceutical Companies and partners are in compliance with Health Authority regulations and guidelines, Good Practices and internal company standards. The Preclinical Domain spans GLP, GCLP, Animal Welfare, and Discovery/non-GLP work.

Key Responsibilities:

• Provide strategic leadership, coaching, and mentoring to direct reports (team leaders of auditors specialized in one or more preclinical subject areas).
• Ensure team is prepared for future business landscape by proactively upskilling staff in new product modalities, data science, technological advancements, etc.
• Establish and manage resource allocation within teams to ensure optimal utilization of resources, including use of outsourced partners or contractors.
• Provide operational leadership to a large team (Team leads & Auditors), performing the different preclinical audit types - Provides operational & strategic support to the R&D Quality QA Center of Excellence (CoE) in particular relating to resource & budget management, audit processes optimization, identification/development/ deployment and oversight of new technologies.
• Promotes a working environment that challenges the status quo; and leads and adapts to change, creating a positive culture.
• Conduct Preclinical QA audits and/or peer review of audit reports, as required.
• Seek solutions and contribute to the strategic direction for the resourcing and execution of the audit plans, schedule and inspection-related activities. Influence the effective implementation of audit processes ensuring global alignment and harmonization across domains and/or segments.
• Oversee the E2E Janssen Preclinical QA audit program, including audit scoping, preparation, execution, follow-up, and Corrective and Preventive Action (CAPA) to meet internal and external regulatory requirements, guidelines and internal standards.
• Support the implementation of a fit for purpose preclinical integrated risk management program in close collaboration with key stakeholders to enable identification and

• management of systemic preclinical risks and ensure adequate proactive mitigation plans are in place to drive resolution.
• Maintain expert level knowledge in preclinical QA domain activities with the ability to provide critical information, advice and guidance on complex issues.
• Serve as primary contact for applicable specific activities related Health Authority Inspections, including inspection readiness and coordinating with other functions as needed.

Qualifications

Education:

• A minimum BA/BS is required, preferably in a scientific or technical field
• Masters in related field, advanced degree preferred.

Experience and Skills:

Required:

• Minimum 10 years professional work experience in the global pharmaceutical or biotech industry
• Minimum 5 years people management experience.
• Must have extensive knowledge of worldwide Preclinical Regulations and Guidelines (GLP, GCLP, Animal Welfare, Discovery/Non-GLP).
• Experience with driving Culture and Change Management across a large organization.
• Experience leading a global multi-site team
• Experience auditing external suppliers performing GLP, clinical lab, and/or discovery/non-regulated study activities.

Preferred:

• Working knowledge of Quality Risk Management and Good Computer Validation Practices is preferred.
• Broad based technical knowledge and skills in diverse areas of business (ex: R&D, Operations, QA, laboratories, etc.)
• Experience working in or providing quality assurance oversight of a regulated bioanalytical/R&D laboratory
• Certification (e.g. Society of Quality Assurance, Registered Quality Professional - GLP - RQAP-GLP).

Other:

• Ability to travel 20-25%, domestic and international required
• Proficient in written and spoken English

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 .