Johnson & Johnson Careers
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Quality and Compliance Manager
Requisition ID: 5282171121
JJMDC markets and distributes medical device and diagnostic solutions for use in institutional and primary health care settings across Canada. We focus on providing minimally invasive treatment options spanning various medical procedures and disease states. Among the products represented by its various business units are: surgical instruments, orthopaedic implants, devices for women’s health including breast care, infection prevention and general purpose sterilizers, hernia solutions, haemostatic products, cardiovascular and neurovascular diagnostics and treatment.
This position manages the Quality and Regulatory Compliance function for CLS (Customer Logistics Services) Canada on behalf of Johnson & Johnson Medical Devices Companies, Janssen, Consumer and J&J Diabetes Services. As such, this position coordinates closely with the CLS Operation, CLS North America Quality and Compliance, Marketing Company Quality and Global Quality & Compliance groups. Specifically, this position develops, coordinates and implements quality compliance programs related to the storage, handling and distribution of a broad portfolio of products including devices, drugs, narcotics, cosmetics and biologic products. Act as an SME with Health Canada and J&J audit such as JJRC. Manages the Distribution Activities to represent quality with action and decisions involving audits, escalations, field actions or other significant quality events. Assures appropriate processes, controls, resources, training and qualifications are in place and effective to ensure a sound compliance profile for CLS Canada in support of current and future business needs.
•Provide leadership and coaching to the CLS Quality team as well as set goals and objectives.
•Develops Quality Agreements with J&J Partner Companies and 3PLs.
•Oversees the quality activities in the DCs, ensuring GMP and GDP compliance for the distribution operations.
•Lead Quality Update meetings with partner company QA Representatives, reporting on key performance metrics.
•Serves as back-up for CLS Quality and Compliance Director and CLS Quality team members.
•Lead the local implementation of JNJ standards
•Ensure quality systems are well integrated into the business in critical areas for control including: product receipt, storage, handling, transportation, supplier control, non-conformance/Corrective and Preventive Action management, change management, document/records management, validation, calibration, preventive maintenance and training. Lead the oversight of these systems within the DCs to drive adherence to established targets. Escalate risks to Senior Management as required.
•Advises management on changes to corporate and government requirements. Provides input into emerging internal and external requirements on behalf of CLS Canada.
•Drives consistent processes and requirements through the DCs and ensures efficient and compliant SOPs across all Partner companies and 3PLs.
•Negotiates with regulatory authorities on quality and compliance issues.
•Responsible for the preparation of the Quality System Management Review presentation, co-present with CLS Quality and Compliance Director to provide regular updates regarding the compliance status and performance of CLS.
•Manages regulatory inspections and compliance activities by performing the following duties personally or through direct reports.
•Represents the company during Health Canada inspections;
•Manages regulatory inspections and external audits via preparation, hosting, audit responds and implementing corrective actions as appropriate.
•Reporting of results to management and J&J Corporate (as required).
•Manages the internal audit program to monitor compliance with corporate and government requirements
•Provides Quality input and support to the CLS Canada training process including 3PL training.
•In partnership with the Director of CLS Quality and Compliance set strategic objectives for CLS Quality in the DCs.
•Responsible for ensuring that associates follow all company guidelines related to Quality and Regulatory Compliance.
•Manages Escalation of issues as per JNJ Standards as directed by CLS Q&C Director
•Participates in projects, acquisitions and divestitures and act as the CLS quality SME.
•Represents CLS Quality on Commercial launch and New Business Development initiatives.
•Manages the Quality performance of the CLS 3rd Party Logistics provider via regular meetings, supplier audits and Quality System reviews. Tracks and provides KPIs / metrics to CLS Operations and CLS Quality to facilitate the review of ongoing quality performance.
•In concert with manufacturing and Marketing Company Quality organizations, establishes and executes Cold Chain processes including validation
•Collaborates with JNJ Pharma, Medical Devices and Consumer on driving common Quality Systems for CLS in Canada.
Relevant knowledge and experience:
•BSc or equivalent in Science or related field, MS/MBA an asset.
•5 to 8 years of experience in the medical device or pharmaceutical industry.
•Experience across the elements of a quality organization – quality systems, regulatory, quality operations and regulatory compliance.
•In depth knowledge of Canadian regulations.
•Experience in leading and managing regulatory agency inspections.
•Experience with the distribution practices and requirements of regulated products (drugs / devices).
•Direct working knowledge of the business environment outside of the Quality organization.
Technical competency requirements:
•Ability to work with broad scope/different types of products in a fast paced environment.
•Ability to build and nurture strong, positive relationships with business leadership and partners including Regulatory Affairs, Sales and Marketing, Source companies and third party service providers.
•Ability to work in a matrix environment with multiple stakeholders and priorities and influence leadership.
•Big Picture Orientation with Attention to Detail to understand complexities of the business
•Capable of working tactically ‘hands on’ as well as strategically with Sr. Leadership.
•Proven track record of Organization and Talent Development and ability to lead in a matrixed environment
•Ability to apply risk management philosophy to business processes, decisions and data.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
Johnson & Johnson Inc. (7695)