Senior Quality Systems Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson is currently recruiting for Senior Quality Systems Specialist! This position will be located in Markham, Ontario. This is a 12 month duration based role.

This position 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 supporting, shaping, monitoring and assessing of key Quality System process and quality system architecture to maintain continuous compliance with Health Canada regulations, while balancing and continuously improving the customer experience.

Primary functions include compliance with appropriate processes/controls for Quality System related activities including but not limited to: change management and change controls, document management, metrics, management review, Non-conformance/CAPA, Supplier management and Field Actions.

• Supports and executes key strategies necessary to deliver on JJMT Commercial Quality’s compliance.

• Shapes, implements and continuously improves JJMT’s Quality Systems and Quality Compliance, to ensure delivery against the strategies and measures.

• Ensure quality systems are in compliance with J&J Standards and regulatory requirements in critical areas including but not limited to: supplier management, non-conformance management, change management, document/records management, training.

• Provide subject matter expertise to project teams; escalate quality and compliance risks to management and project governance as required.

• Supports quality deliverables on projects and ensures project timelines are met.

• Supports cross-functional coordination with cross-functional teams: RA, Commercial, Supply Chain etc.

• Other duties as assigned

Relevant knowledge and experience

• BSc or equivalent in Life Sciences or related field, post graduate program in Quality is an asset.
• Minimum 2 to 4 years of experience working in a regulated environment.
• Experience required in a device Quality/Regulatory environment.
• Strong knowledge of 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), quality operations and regulatory compliance.

• Strong knowledge of Canadian regulations: Medical Device Regulations, Food & Drug Act, GMPs.

• Ability to work with ambiguity and in a complex/rapidly changing environment and make the complex simple for others to understand.

• Other duties as assigned

• Ability to build and nurture strong, positive relationships with business leadership and partners including Regulatory Affairs, Commercial Quality partners, Source companies and third-party service providers.

• Ability to work in a matrix environment with multiple stakeholders and priorities.

• Detail-oriented with a “big picture” risk-based approach; able to apply risk management to decisions and process design.

• Ability to identify risks and propose mitigation strategies

• Results-oriented, proactive, and comfortable working independently with minimal supervision

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: