Quality Systems & Compliance Specialist

At Johnson & Johnson,we believe health is everything.
Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Markham, Ontario, Canada Job Description: Johnson & Johnson is currently seeking a Quality Systems & Compliance Specialist to join our MedTech Surgery Commercial Quality team located in Markham, ON, Canada.
This is an 18-month fixed-term role with 3 days in office per week. About Surgery Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world.
Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer.
Patients are waiting. Your unique talents will help patients on their journey to wellness.
Learn more at https://www.jnj.com/medtech The J&J MedTech Surgery Commercial Quality Canada team is seeking a Quality Systems & Compliance Specialist for an 18-month contract position, reporting to the Quality Systems & Compliance Manager.
This role is responsible for supporting and maintaining Quality Management System (QMS) and ensuring compliance with applicable Health Canada regulations and J&J Corporate Standards.
This position has primary responsibility for quality systems and compliance activities at the Markham Shared Distribution Centre (SDC), which stores and distributes products for J&J MedTech, J&J Innovative Medicine and J&J Surgical Vision.
In this capacity, the Specialist will partner closely with DELIVER Operations, MedTech Business Unit Quality teams, Commercial Quality Segment teams across Innovative Medicine, Vision and Shared Services, as well as Supply Chain Planning, Marketing and 3PL Operations and Quality to support quality oversight, compliance activities, and continuous improvement initiatives across the distribution network. Key Responsibilities * Oversees and supports Markham SDC's daily issues or 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. * 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. * Supports regulatory inspections, JJRC and internal/external audits via preparation and implements corrective actions as appropriate * Supports Commercial Quality Segment teams for their external audits impacting storage and handling of products at the Markham SDC * Serves as one of the primary contacts between Global Manufacturing sites and J&J MedTech Canada for product Hold process.
Leads holds/stop shipments to ensure products are investigated, segregated and on ERP system-hold.
Connects with appropriate stakeholders to ensure holds/stop shipments are executed in timely manner.
Leads follow-ups with Global Manufacturing Sites to provide product disposition and closure status. * Supports as Master Data Governance Functional Data Steward on behalf of MT Surgery Commercial Quality * Serves as backup contact for Supplier selection/qualification/audits/remediation activities for MT Surgery Commercial Quality.
Activities include but not limited to Supplier selection, on-going monitoring, disengagement, supplier qualification, supports review of quality agreements, collaborates appropriate internal/external functional groups to select, qualify, disengage suppliers as necessitated while implementing risk-based approach, ensures J&J Policies / Standards are met. * Supports quality deliverables on projects, acquisitions and divestitures and ensures project timelines are met. * Conducts gap assessments and develop local implementation against J&J standards * Advises management on escalation of issues as per J&J Standards as directed by Business Unit * Serves as back-up for MT Commercial Quality Manager and MT Commercial Quality team members for the SDC * Other duties as assigned Qualifications * 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 or pharma Quality/Regulatory environment * Strong knowledge of medical device and/or pharma 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 * Experience in supporting inspections (health authority inspections, internal audits, external audits) * Experience with the distribution practices and requirements of regulated products (medical devices and pharmaceuticals). * 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 * Big Picture Orientation with Attention to Detail to understand complexities of the business * Ability to work in a matrix environment with multiple stakeholders and priorities * Ability to apply risk management philosophy to business processes, decisions, and data * Sense of urgency, results and performance driven; and works independently with minimum supervision. Required Skills: Preferred Skills: Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing The anticipated base pay range for this position is : $65,000.00 - $103,500.00 Additional Description for Pay Transparency: Compensation: • The anticipated base pay range for this position is $65,000-$103,500 CAD • Under current guidelines, this position is eligible for a discretionary completion bonus. • The Company uses AI in its assessment of applicants. • This job posting is for an existing position Benefits: https://jnjbenefitsguide.ca/ We have a flexible benefits plan (incl.
company paid medical; dental; vision coverage) that gives several options/plans to choose from depending on family needs.
Benefits are effective as of the first day of work: • Basic life insurance coverage • Both short-term and long-term disability coverage • AD&D (Accidental Death & Dismemberment) coverage • RRSP (Registered Retirement Savings Plan)- there is a company match of 50% up to 4% employee • contribution • 3 weeks' vacation plus 4 floater days • 5 personal time-off days 5 Sick days • 2 company-paid volunteer days per calendar year Accessibility for Ontarians with Disabilities Act Statement: 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. Live Engagement: We provide an inclusive work environment where each person is considered as an individual.
If you require any accommodation at any point in the recruitment process, please let us know and we will work with you in an effort to ensure that you are able to fully participate in the process.