Associate Director, Compliance, Strategy & Analytics International - 2 Openings
Janssen Research & Development, a part of the Johnson & Johnson family of companies, is recruiting for a Compliance, Strategy & Analytics International Associate Director, Global Medical Organization located in the United States or EMEA.
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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Compliance, Strategy & Analytics (CSA) International Associate Director is responsible for executing upon the strategic objectives of CSA International in close cooperation with the Head, CSA International.The incumbent supports the IPV Organization to manage compliance risk and to fulfil its obligations with respect to the Local Operating Companies ability to meet and maintain pharmacovigilance compliance standards. The position will report to the Senior Director, Head CSA International.
This role operates as a multi-skilled leader for CSA International including: an IPV CAPA leader in close collaboration with the CSA PV CAPA COE; a Training and Document Control (TDC) leader in collaboration with CSA TDC COE; an Inspection Readiness leader, in collaboration with CSA Head of Inspection Readiness, BioResearch Quality & Compliance (BRQC) and Business Quality; and will lead the ongoing development and evaluation of key performance indicators for the IPV organization in collaboration with CSA Metrics COE.
This position is accountable to independently oversee and support the IPV system and processes across the full spectrum of compliance and quality activities to support both high standards of compliance and standardized execution. This position is accountable to work across functional lines and geographies and to influence Senior Leaders in Global Medical Organization (GMO) and Office of Consumer Medical Safety (OCMS) to support a governance strategy that overall mitigates compliance risk for the IPV organization. This position is required to act as a delegate for the Senior Director, Head of CSA International, when required.
Training and Document Control
- Coordinate collection and dissemination of compliance and business performance metrics and support the resolution of non-compliance, and evaluate metrics to oversee frameworks
- Execute upon the joint CSA and IPV strategy to ensure overall qualification and effectiveness of LSO training program
- Manage an IPV tailored training framework to support the use of role-based Local Safety Officer (LSO) curricula, facilitate Global LSO training in cooperation with IPV Global Operations Coordinate with Training & Document Control to develop and deploy dual sector Adverse Event/ Product Quality Complaint (AEPQC) training.
- Manage the IPV procedural documents framework in close cooperation with CSA TDC and IPV Global Operations, in addition to owning, maintaining, and aligning all other related CSA International controlled documents to standards, policies, and related requirements
- Coordinate with IPV and TDC in the periodic review assessment of IPV Procedural Documents and conduct annual curriculum reviews (LSO)
IPV CAPA & CAPA Review Board
- Take a leadership role in representing the needs of IPV business in cross functional fora for resolution of cross functional issues in the pursuit of aligned Local Operating Company (LOC) PV CAPA processes, as well as develop and manage a process of formal data feeds, trend analysis arising from IPV PV CAPA into the E2E PV CAPA process owned by CSA PV CoE
- Support the Level One IPV CAPA Review Board (CRB) in the review, distribution and follow-up of CAPA Forecast reports; compilation of the meeting materials; supporting LSOs in the presentation of new Investigation records; tracking meeting actions
- Support LOC audits and regulatory inspections and help drive inspection readiness in-the -area of end-to-end CAPA management, and develop manage a formal follow-up and escalation process within the IPV organization of open and overdue CAPA
- Take the lead to implement and execute upon the IPV/Local Safety Unit governance structure for inspection readiness, and the ongoing monitoring of the inspection readiness state of the IPV organization using key/leading indicators
- Influence across key business partners and IPV Leadership to manage a program of inspection readiness for IPV, as well as develop and execute process improvements in the IPV Inspection Readiness process and system and escalate as needed to CSA Head Inspection Readiness.
- Drive the development of actions in response to quarterly trending metrics, quality improvements, and resolution of IPV compliance risks in collaboration with key stakeholders and IPV business, as well as represent IPV compliance metrics at stakeholder meetings
- Manage the completion of IPV Risk Based Assessments.
- Collaborate with CSA Compliance COE and IPV organization to maintain oversight of LOC Inbound Compliance trends, and take the lead to drive Scorecard enhancements/updates to align with LOC Inbound and Regulatory Compliance requirements.
- Be the CSA International primary point of contact for escalation of IPV/LOC quality and compliance issues.
- A Bachelor's degree or equivalent University Degree, preferably in life sciences and at least 6 years of relevant experience is required. A post-graduate degree is preferred
- At least 5 years of experience in a regulated or drug safety department or equivalent pharmaceutical regulatory environment is desirable
- Knowledge and experience in drug safety processes is required
- Experience in a diverse and evolving global organization, leading and influencing large groups in training settings
- Project management, process excellence, and/or experience improving processes in a complex, global environment is preferred
- Ability to act in a consultative role to analyze processes in place and suggest improvements
- Demonstrated subject matter expertise in managing Quality Management Systems and CAPA is required
- Experience in Quality Management and/or Process Excellence concepts and practices are preferred
- Exceptional formal presentation skills with the ability to work across cultures, and establish successful working relationships at all levels within the organization, and influence at Senior levels is required
- Ability to travel up to 10%
United States-New Jersey-Titusville
North America-United States, Europe/Middle East/Africa
Janssen Research & Development, LLC. (6084)
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