This position supports the Quality and Regulatory Compliance function for DELIVER Canada on behalf of Johnson & Johnson Medical Products, Janssen and J&J Vision Care. As such, this position coordinates closely with the DELIVER Operations teams, DELIVER North America Quality and Compliance, Marketing Company Quality and Global Quality & Compliance groups to support the DELIVER Quality and Compliance organization in Canada. Specifically, this position, 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. This position supports the DELIVER Canada organization with external and internal regulatory audits such as Health Canada and J&J JJRC. Takes direction from DELIVER Leadership to execute the Quality Strategic Objectives and implements the overall company strategy. Will support and influence to represent quality with action and decisions involving audits, escalations, field actions or other significant quality events. Assures compliance to appropriate processes, controls, training and qualifications followed to ensure a sound compliance profile for DELIVER Canada in support of current and future business needs. Drives processes and systems to ensure that appropriate interfaces are in place end-to-end with Supply Chain and the Marketing Companies to which DELIVER provides services.
- Oversees Distribution Centers’ daily issues/inquires at the Markham Distribution Center and the 3PL sites for all products.
- Supports key strategies (tactics, projects, goals and objectives, etc.) and related measures/metrics necessary to deliver on the DELIVER business, compliance and culture/credo goals
- Executes the tactics, projects and goals and objectives across the Quality Systems and Quality Compliance, to ensure delivery against the strategies and measures.
- Ensure quality systems are well integrated into the business in critical areas for control including: product receipt, storage, handling, transportation, supplier control, non-conformance management, change management, document/records management, validation and training
- Advises management on changes to corporate and government requirements. Provides guidance to organization in interpreting and implementing changes. Provides input into emerging internal and external requirements on behalf of DELIVER Canada.
- Interfaces and builds partnerships with source companies, Marketing companies and third-party suppliers. Drives consistent processes and requirements through the establishment of efficient and compliant SOPs across all Partner companies and 3PLs.
- Supports audits with regulatory authorities on quality and compliance issues
- Gathers metrics and data needed for the Quality System Management Review regarding the compliance status and performance of DELIVER.
- Supports regulatory inspections and compliance activities
- Supports the company during Health Canada inspections;
- Supports regulatory inspections and external audits via preparation, internal audit and implementing corrective actions as appropriate.
- Collecting results to be reported to management and J&J Corporate (as required).
- Supports the internal audit program to monitor compliance with corporate and government requirements
- Provides Quality input and support to the DELIVER Canada training process.
- Implements Quality and Compliance organizational strategic goals and objectives.
- Follow all company guidelines related to Quality and Regulatory Compliance and that all resources needed to do so are available.
- Responsible for supporting the Escalation of issues as per JNJ Standards.
- Drives quality aspects on projects, acquisitions and divestitures.
- Implements and executes the quality system to ensure adherence to Good Manufacturing/Distribution Practices.
- Supports DELIVER Quality on Commercial launch and New Business Development initiatives.
- Oversees the Quality performance of the DELIVER 3rd Party Logistics provider via regular meetings, supplier audits and Quality System reviews. Tracks and provides KPIs / metrics to DELIVER Operations and DELIVER Quality to facilitate the review of ongoing quality performance.
- In concert with manufacturing and Marketing Company Quality organizations, executes Cold Chain processes including validation and lane study strategies
- Acts as back-up for the DELIVER Quality & Compliance Sr. Specialist/Manager
- BSc or equivalent in Life Sciences or related field, MS/MBA an asset.
- 3-5 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
- Ability to work with ambiguity and in a complex/rapidly changing environment and make the complex simple for others to understand
- 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.
- 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
- Demonstrates Strategic Thinking capabilities including ability to help define a vision for the future, translate strategy to execution and drive the organization forward in delivering results
Johnson & Johnson Inc. (7695)