Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director Quality Systems Compliance. This role may be based at any Johnson & Johnson location, worldwide; New Jersey or Pennsylvania location is preferred. May consider remote.
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 @JanssenGlobal.
The Director Quality Systems Compliance, is a Global role reporting to the Pharma Segment Quality Systems Lead. • Owns the process for deploying internal/external standards to Janssen to keep us ahead of emerging health authority expectations! This includes oversight and continuous improvement of monitoring, assessment and implementation activities globally.
• Leads global deployment activities for select external standards/regulations impacting global Quality Systems. • Provides strategic direction to ensure internal audit programs are adequately defined and executed to account for new/emerging regulations and standards. • Drives simplification and standardization of audit process and execution across Janssen to ensure compliance with new and emerging regulatory standards and requirements. • Leads and develops talent for Pharm Quality System Compliance group – 1 direct report. • Contributes to our future design as we build our operating model for Digital Health Solutions for patients and Health Care Providers around the world.
Key Responsibilities: • Acts as Global Owner of the Janssen Adopting Regulatory Requirements (ARR) process. Leads cross-functional Council meetings and drives process improvements to ensure monitoring, identification, assessment, and implementation of new or revised regulatory requirements and standards impacting Quality Systems. Builds and presents metric reports to ensure Leadership awareness of risks and adherence to the process. • Leads implementation initiatives for new or revised external standards and regulations. Develops and leads cross-functional teams to ensure gap and impact assessments are executed and remediation plans are in place. Crafts and reports metrics to ensure management awareness of status. • Leads the process for deployment of internal J&J Standards into the Pharmaceutical Segment. Identifies Process Owners and Functional Area representatives, trains owners on requirements for Sector-level assessment, and monitors and reports on the status of gap assessment and deployment across end-to-end functions of Janssen. • Acts as Janssen lead on the Enterprise Standards and Process Council. Acts as an advocate for the Pharma Segment to define strategy and assure awareness and implementation of Enterprise priorities. • Participates as Pharma representative on Enterprise alignment projects related to external standards monitoring and audit standardization. Works to simplify and standardize processes across Janssen. • Leads integration activities to assure inclusion of new/emerging regulatory requirements (e.g combination products) into internal audit processes. • Ensures internal audit procedures remain current and up-to-date, and applicable global and virtual organizations are subject to appropriate audit cadence. In partnership with Regulatory Compliance, ensures audit planning and execution according to J&J policies. • As needed, provides compliance support in relation to new or emerging regulations (e.g. awareness training, supporting the development of remediation plans, attending and presenting at external conferences to shape external environment, etc.). • Boldly innovates in the space of Digital Health! Contributes to the definition and delivery of a future-state operating model to support design, build, deployment and lifecycle management of patient-facing digital assets.
• A minimum of a bachelor’s degree required. • Minimum 10 years of related experience in the pharmaceutical or similarly regulated industry • Minimum 5 years of experience working with Quality Systems (change control, CAPA, audit, etc.). • Demonstrated proficiency and experience in working with Quality Systems IT applications • May require occasional travel <5% as business needs arise
Preferred Experience and Skills: • Experience in both medical device and pharmaceutical industries • Current Auditor Certification (CQA, ISO Lead Auditor, etc.) • Experience in leading or participating in Quality Systems IT projects • Familiarity with deploying and managing global standards and processes • People leadership including direct reports • Knowledge of worldwide Health Authority Regulations, including Digital Health and Software as a Medical Device (SaMD) requirements • Experience collaborating, influencing and negotiating with dynamic, global, diverse leaders and stakeholders representing the End-to-End value chain.
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Internal Number: 9638200804
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