Janssen Pharmaceutical Companies of Johnson & Johnson is currently recruiting for an Associate Director, BioResearch Quality Assurance, Local Operating Company Team Lead/Domain Expert (Americas Region) to be based at either Raritan, NJ; Titusville, NJ; or Spring House, PA.
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 Associate Director, BioResearch Quality Assurance, Local Operating Company Team Lead/Domain Expert (Americas Region) will:
- Be a domain-specific, strategic role that drives enhanced Pharmacovigilance (PV), Good Clinical Practices (GCP), and Quality Management System (QMS) compliance throughout the Multi-Discipline domain.
- Independently lead and manage the planning, conduct and reporting of LOC (Local Operating Company) domain-specific compliance audit programs to ensure that the programs and functions for Janssen Pharmaceutical Companies (and all partners) are in compliance with company standards, Health Authority (HA) guidelines and regulations.
- Lead a team of domain-specific or cross-functional auditors and is a member of the Multi-Discipline domain QA Leadership Team.
- Be responsible for the supervision and development of direct reports, managing staffing decisions and allocation of appropriate auditors to scheduled audits.
- Serve as a primary contact with business partners or other BRQC organizations, establishing and maintaining effective relationships, driving collaboration and providing expert-level GxP knowledge and guidance on complex issues.
- Take an active role in, and lead key project initiatives across the organization or company, and independently provides strategic advice to internal or external stakeholders to drive policy and decision making.
- Provide expert support to auditors and the business when developing CAPAs and influences consistency of CAPAs for similar issues and drives resolution of complex CAPAs and serves as backup to auditors to support CAPA timelines.
- Be responsible for the execution of domain-specific compliance audit programs to ensure that the programs and functions are in compliance with company standards, Health Authority guidelines and regulations.
- Serve as backup for auditors during periods of high workload, and may conduct audits, and assessments of the J&J Pharmaceutical sector worldwide, including J&J Operating Companies (including Consumer for pharmacovigilance), partners and service providers, with emphasis on complex and business critical audits.
- Be a key contributor to relevant domain communities of practice.
- Maintain expert level GxP knowledge in at least one regulated discipline (GCP/PV/QMS) with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
- Guide auditors in the scope definition, planning, conduct and reporting of LOC audits, providing regulatory and process expertise within the designated domain.
- Be directly responsible and accountable for supervision and development of direct reports (a team of auditors specialized in one or more GxP disciplines).
- A minimum of a Bachelor of Science (BSc) or Arts (BA) degree (or equivalent degree) is required
- An advanced degree (MSc or above) is preferred
- A minimum of 10 years’ experience in a Health Authority regulated environment (FDA, MHRA, EMEA, etc.) is required
- A minimum of 5 years of experience in a R&D and/or quality and compliance area is required
- Thorough knowledge of the drug development process is required
- Expertise/extensive experience in pharmacovigilance is required
- Strong knowledge of other compliance disciplines such as GCP and/or QMS is preferred
- Knowledge of procedural and records management requirements in a regulated industry is preferred
- Knowledge of auditing techniques is preferred
- Ability to operate in a matrix environment and work effectively in a dynamic, problem-solving team centered environment is required.
- Position will be located at Raritan, NJ; Titusville, NJ; or Spring House, PA and may require overnight travel, domestically and internationally, up to 40%.
United States-New Jersey-RaritanOther Locations
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function