NA Sr Manager QS and Perf Monitoring
- Toronto, ON
- Permanent
- Full-time
- Quality System Management Review (QSMR) Lead for the North American Region including commercial businesses of all therapeutic areas for both US and Canada. Continuously assess the health and performance of the QMS and identify high risk areas, work with business partners in CQ NA to address with CAPA where appropriate. Specific areas of responsibility include:
- Analyze and report US and Canada Quality System metrics
- Prepare and lead CAPA Review Board meetings
- Implement and continuously evaluate the quality systems as per current US and Canadian GxP requirements
- Understand North American LOC including US and Canada needs related to quality system and processes
- Coordinate the QSMRs for the US and Canadian LOCs, providing in-depth data analysis of product information including complaint data. Prepare annual Quality Review for Puerto Rico. Ensure compliance awareness is highlighted and addressed in the QMR updates to the commercial boards.
- Serve as CQ NA lead on the QSMR/Metrics Community of Practice to ensure alignment across all regions and to introduce analytical improvements for data gathering and QSMR preparation.
- Support regional Commercial Quality organization and partner with other LOCs to build quality processes and maintain the compliance with J&J standards, ensuring identification and deployment of key processes with other regions.
- Evaluates, monitors, and reports on internal compliance metrics, including CAPA, NC, Escalations, audit commitments, change controls, etc., ensuring appropriate management oversight and notification of compliance risk per company standards and/or in support of Management Review,
- Strategic key performance indicator development for critical compliance programs across North America (e.g Drug Establishment Licensing, Confirmatory testing, etc. in Canada).
- Serves as the Chair of the monthly CAPA Review Board meeting for Scientific Affairs, Medical Affairs, Deliver, Sample Compliance and CQ NA (US and Canada), facilitating non-conformance and CAPA oversight, timely completion of CAPA, identification of overdue CAPA or resource issues. Ensures ongoing documentation and reporting on CAPA Review meeting activities.
- Prepare for, participate in and actively support as SME for North American CQ internal, HA audits, (Global CQ audits as the need arises) and ensures commitments are delivered on time.
- Prepare Quality Plans annually for both the US and Canada.
- Master Data lead for CQ North America and key stakeholder on global digital initiatives related to Quality Systems.
- Required: BA/BS – Chemistry/Microbiology/Technical/Life Science
- Desirable: MA/MS/MBA – Business/Technical/Life Science
- Frequently collaborating with other partners such as Scientific Affairs, Global Medical Organization, Supply Chain, Innovative Medicine Sector Quality System, Global Regulatory Affairs, Enterprise Quality. Occasionally interacting with external service provider or vendors. Participate in or Lead CQ process improvement initiatives and projects related to the QSMR and metrics topics.
- Highly collaborative and strong partnership skills to actively participate on teams and represent the commercial business.
- Partnership mentality to ensure cross functional team alignment is acquired.
- Minimum 10-years’ experience in the Pharmaceutical or related industry;
- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP/GDP in both US and Canada
- Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers, partners and senior leadership across commercial functions
- Proven strong influence across cross-functional groups.
- Outstanding communication (verbal, written), interpersonal and project management skills
- Canadian and US FDA Regulatory Requirements knowledge
- Demonstrates agility and adaptability in learning new technologies and business processes
- Able to prioritize and pull information together from multiple business units to ensure concise consolidated business picture is communicated to the commercial businesses.
- Able to balance project management aspects in conjunction with daily work.
- Outstanding attention to accuracy and details
- Role location can be at an Innovative Medicine office in Ontario, Canada or New Jersey, US with up to 10% travel.
- This role may act as a delegate for: Director, Commercial Quality Excellence North America