Quality & Compliance Specialist

Johnson & Johnson MedTech Canada a member of the Johnson & Johnson’s Family of Companies is recruiting for a Quality & Compliance Specialist
- This is a duration-based position for one (1) year. _

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.

With $76.5 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The J&J Supply Chain is an integrated, global supply chain that serves the needs of the 1 billion people who use J&J products each and every day around the world. We manufacture more than 26 billion product units per year, from raw component sourcing to end product distribution as efficiently and effectively as possible with high quality, compliance and service performance. Our supply chain organization makes up 45% of all J&J employees, and includes 125 internal manufacturing plants, manages 581 external manufacturers, utilizes 459 distribution centers, partners with over 3700 direct suppliers, produces over 300,000 sku’s.

The Quality & Compliance Specialist will be responsible for support and maintenance of the Quality System and Compliance within the requirements of Health Canada and J&J Corporate Standards. This position has primary responsibility for the Quality & Compliance requirements at the Markham Shared Distribution Centre (SDC) which stores and distributes products for J&J MedTech (MT), Janssen and J&J Surgical Vision. As such, this position coordinates closely with DELIVER Operations, MT Franchise Quality teams, Commercial Quality Segment teams (Janssen, Vision and Shared Services), Supply Chain Planning, Marketing and 3PL Operations & Quality teams. Primary functions includes compliance to appropriate processes/controls for Quality System related activities including but not limited to: change management and change controls, document management, quality agreement negotiations, collaborative partner to third-party logistics (3PL) provider.

**Key Responsibilities**:

- Supports quality deliverables on projects, acquisitions and divestitures and ensures project timelines are met (i.e. QMS updates with new legal entity for MedTech)
- Ensure quality systems are well integrated into the business in critical areas for control including but not limited to: product receipt and inspections, storage and handling, supplier management, non-conformance management, change management, document/records management, training to ensure compliance with J&J Standards and regulatory requirements
- Oversees and supports Markham SDC’s daily issues / inquiries
- Supports and executes key strategies and related measures/metrics necessary to deliver on MT Commercial Quality’s and Deliver Operations’ 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.
- Interfaces and continues to build strong partnership with 3PL. Works closely with 3PL Quality & Operations teams on documentation reviews, process improvement initiatives, quality systems robustness review, supplier monitoring inspection, quality agreement negotiations.
- Supports regulatory inspections, JJRC and internal/external audits via preparation and implements corrective actions as appropriate.
- Advises management on escalation of issues as per J&J Standards as directed by Franchise.
- Serves as back-up for MT Commercial Quality Manager and MT Commercial Quality team members for the SDC.
- Other duties as assigned.

**Qualifications**:
**Qualifications**

**Education**:

- Minimum of Bachelor’s degree or University degree required; advanced degree or focused degree in Life Sciences or related field, post graduate program in Quality preferred.

**Experience and Skills**:
**Required**:

- Minimum of two (2) years of relevant work experience in a regulated device or pharma Quality/Regulatory environment
- Strong knowledge of pharma and/or device Quality Management Systems;
- Knowledge of GMP's, GDP's, Quality Systems, Canadian Drug and Medical Device Regulations
- Experience across the elements of a quality organization - quality systems (CAPAs, NCs, Change Controls)