Associate Director, L&A Risk Management

Company: Johnson & Johnson
Location: Raritan
Posted on: April 10, 2021

Job Description:

Job Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, L&A Risk Management to be located in Raritan, NJ with flexibility for remote work in the US or EMEA. Work location is flexible if approved by the Company except that the position may not be performed remotely from Colorado.

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 and follow Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Associate Director, L&A Risk Management is a member of the Quality Planning and Strategy (QP&S) group in BioResearch Quality & Compliance (BRQC) Janssen. This role will foster a positive, collaborative business relationships in order to aid the company with adoption of the Janssen quality management system and defined business operating model.

Principal Relationships Inside the Companies

This leader will interact with newly acquired companies, Licensing & Collaboration Partners as well as key R&D functional partners and BRQC leadership.

Principal Relationships Outside the Companies

This leader may interact with quality, R&D, and medical safety professionals in third-party organizations and marketing partners, as needed.

Main responsibilities will include, but are not limited to:

• Function as a key member of cross-functional due diligence teams led by Janssen Business Development (JBD) to lead and coordinate GCP and medical safety compliance assessments activities with business partners & interface with JBD/Scientific Licensing project leads to report potential quality risks for consideration during L&A or M&A
• Lead integration from legacy quality management systems (QMS) into Janssen R&D's QMS in accordance with the obligations defined in the master contract, as assigned.
• Lead and/or support L&A risk management improvement initiatives
• Collaborate with internal and external partners to deliver innovative solutions and create value
• Support the strategic, prospective, end-to-end (E2E) BRQC Janssen integration quality support model, in conjunction with newly acquired company and key Pharma segment R&D partners to proactively manage quality and minimize delays to development timelines and inspection findings
• Develop and present quality integration dashboards and summaries to drive transparency with the progress of integration activities and ensure adequate follow-up & closure of actions
• Support J&J Enterprise sponsored post-acquisition assessment (PAA) activities in compliance with corporate quality policies and standards as assigned
  Qualifications
  
  • A Bachelor's degree (Science or Business preferred) or equivalent is required. MBA or Master's degree preferred
  • A minimum of 8 years of overall relevant experience required
  • Project management experience is required
  • Experience in Clinical Operations, Supply Chain, or Quality role is required
  • Experience in a regulated industry is required, experience in Pharmaceuticals is preferred
  • Experience in a cGCP or cGLP is preferred
  • Experience working with cross-functional teams and working with Business Development Deals preferred
  • Experience making decisions independently and ensuring confidentiality of business-critical activities is preferred
  • Experience working with senior leadership to resolve operational issues impacting critical deliverables preferred
  • This position is located in Raritan, NJ with flexibility for remote work in the US or EMEA. Work location is flexible if approved by the Company except that the position may not be performed remotely from Colorado. This position may require up to 10% of travel both internationally and domestically.
    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.
    
    

Keywords: Johnson & Johnson, Trenton , Associate Director, L&A Risk Management, Executive , Raritan, New Jersey