Quality Compliance Manager

COMPANY OVERVIEW:

Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium hyaluronic acid (HA) dermal fillers and cosmetic products. We are proud to address all of our client's needs through streamlined innovation. Prollenium is able to ensure a continual flow of creation, unique ideas, and a steady pipeline of new and exciting products that provide safe and effective results. With regulatory approvals from the US FDA and Health Canada, Prollenium has sold over 5 million syringes from its Revanesse® product line across more than 80+ countries worldwide. Prollenium was the first manufacturer of hyaluronic acid dermal fillers in North America. Join our dedication to innovation. Prollenium provides competitive compensation, benefits, and development opportunities.

JOB SUMMARY:

The Quality Compliance Manager leads the Quality Compliance team at Prollenium Medical Technologies (PMT) Inc. and is accountable for keeping PMT’s Quality Management System (QMS) compliant, effective, and inspection-ready across all markets where PMT products are sold (Canada, USA, EU, Brazil, Australia, and others). The role owns the internal audit, external inspection, CAPA, complaint handling, vigilance, post-market surveillance, supplier qualification, training, and management review programs for medical devices, drug (DEL) activities, and cosmetic products. The Quality Compliance Manager provides independent oversight that the QMS meets regulatory requirements and is working as intended. This role reports directly to the Director of Quality.

MAJOR RESPONSIBILITIES:

Personnel Management

• Manage, coach, and develop direct reports.
• Set team goals, conduct performance reviews, and plan workload and resources against the annual compliance calendar.
• Ensure direct reports are trained and qualified (including auditor qualification) and maintain their training records.
• Build a culture of compliance, data integrity, and continuous improvement across the organization.

Regulatory Compliance & QMS Oversight

• Own compliance of the QMS against ISO 13485, US FDA 21 CFR Part 820 (QMSR), Health Canada Medical Device Regulations, EU MDR 2017/745, MDSAP, Brazil ANVISA, Australian TGA, and other applicable requirements.
• Ensure GMP compliance applicable drug/combination products as required.
• Ensure compliance of cosmetic products with Health Canada Cosmetic Regulations, US MoCRA, EU Cosmetics Regulation 1223/2009, and ISO 22716 (Cosmetic GMP).
• Support compliance with the QC laboratories in collaboration with QC management
• Lead regulatory intelligence with support from RA: monitor new and changing regulations and standards, assess their impact on PMT, and drive gap assessments and closure plans.
• Approve QMS procedures and records as the compliance reviewer, ensuring procedures reflect actual practice and current requirements.
• Maintain the standards register (external standards list) and ensure standards are kept current.
• Ensure State Licensing (Boards of Pharmacy) requirements for the US market is maintained.

Audits & Inspections

• Own the annual internal audit program: risk-based schedule, qualified auditors, reports, and follow-up to closure.
• Lead inspection readiness and act as host/front-room lead for Notified Body, MDSAP, Health Canada, FDA, INMETRO, a[JL1] [DA2] nd customer audits at the Richmond Hill and Aurora sites.
• Plan and run mock inspections and compliance walk-throughs (GEMBAs) in partnership with QA.
• Prepare and approve audit and inspection responses (e.g., MDSAP nonconformities, FDA Form 483 responses) and ensure commitments are met on time.
• Maintain the external audit and certification schedule, and keep certificates and licences current (ISO 13485/MDSAP, CE certificates, MDEL, DEL, INMETRO).

CAPA, Deviations, Change Management & Nonconformance Oversight

• Own the CAPA program, ensuring root cause analysis is robust, actions are risk-based, and effectiveness checks are performed.
• Chair or facilitate the CAPA Review Board; track aging, overdue items, and repeat issues and escalate as needed.
• Trend deviations, nonconformances (NCRs), OOS results, and audit findings to identify systemic issues and trigger CAPA.

Complaints, Vigilance & Post-Market Surveillance

• Own the complaint handling process, including adverse event assessment, investigation coordination, and on-time closure.
• Ensure on-time regulatory reporting, including Health Canada mandatory problem reports, FDA Medical Device Reports (21 CFR Part 803), EU MDR vigilance (serious incidents, FSCAs), ANVISA technovigilance, TGA, and cosmetic serious adverse event reporting under MoCRA.
• Lead the Post-Market Surveillance (PMS) system: PMS plans and reports, Periodic Safety Update Reports (PSURs), trend reporting, and input to Post-Market Clinical Follow-Up (PMCF), in collaboration with RA, Clinical and QA.
• Lead or coordinate recalls, field safety corrective actions, and mock recalls with Health Canada, FDA, competent authorities, and distributors.

Supplier Compliance

• Own the supplier qualification and monitoring program (critical and non-critical suppliers), including the Approved Supplier List.
• Ensure the supplier audit schedule is met and supplier CAPAs and quality agreements are in place and current.
• Partner with the QA Manager, who leads day-to-day oversight of CMOs and 3PLs, to make sure supplier controls meet regulatory requirements.

Training & Competency

• Own the company-wide training program and training matrix in the electronic QMS (eQMS).
• Ensure role-based training is current for all GMP/QMS roles and report training compliance metrics.
• Deliver or arrange training on regulations, GMP, Good Documentation Practices (GDP), and data integrity.

Data Integrity & Computerized Systems

• Lead the data integrity program in line with ALCOA+ principles, 21 CFR Part 11, EU GMP Annex 11, and Health Canada guidance.
• Provide compliance oversight of computerized system validation (CSV) using a risk-based approach (e.g., GAMP 5) for eQMS, ERP, laboratory, and e-signature systems.
• Conduct periodic data integrity reviews and walk-throughs in manufacturing, QC labs, and warehouse.

Management Review, Metrics & APQR

• Lead preparation of Management Review and Annual Product Quality Review (APQR) inputs, and present QMS performance to senior leadership.
• Define and report compliance KPIs (e.g., CAPA on-time closure, complaint trends, audit findings, training compliance, reportable events).
• Ensure Management Review actions are assigned, tracked, and closed.
• Act as delegate for the Management Representative

Change Control & Cross-Functional Support

• Provide compliance review of significant changes to confirm regulatory impact and notification needs are assessed (e.g., Notified Body, Health Canada, FDA, ANVISA).
• Chair or facilitate the Change Control Review Board; ensure new changes are presented in a timely manner, track aging change controlsand escalate issues.
• Partner with QA, RA, QC, Manufacturing, R&D and Supply Chain on compliance projects, new product introductions, and system changes.
• Support RA with licence maintenance (MDEL, DEL, cosmetic notifications) and provide QMS evidence for regulatory submissions.

Additional Responsibilities

• Attend meetings and participate in company projects.
• Manage the Quality Compliance budget items (e.g., audit, certification and training costs) as assigned.

MINIMUM QUALIFICATIONS:

Technical Knowledge/Experience

• 7 or more years in Quality Compliance or Quality Assurance in a regulated environment (medical devices, pharmaceuticals/GMP, or cosmetics), with at least 2 years in a people leadership role.
• University degree in Life Sciences (chemistry, biology, pharmacy, or similar) or Engineering. Graduate degree considered an asset.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820 (QMSR), Health Canada Medical Device Regulations, EU MDR 2017/745, ISO 14971, and GMP (Health Canada Part C Division 2 / 21 CFR 210/211).
• Proven experience hosting or leading regulatory inspections and certification audits (FDA, Health Canada, Notified Body, MDSAP).
• Hands-on experience managing CAPA, complaint handling, vigilance reporting, internal audits, and supplier qualification programs.
• Excellent written and oral communication skills, including the ability to present to senior leadership and regulators.

Behavioral

Demonstrated ability to apply the following behavioral competencies on the job:

• Leadership: Leading, developing, and motivating the team and influencing across departments.
• Integrity and Independence: Raising compliance concerns objectively and escalating when needed.
• Problem Solving: Anticipating, analyzing, and resolving complex compliance issues.
• Organization and Planning: Managing multiple audits, deadlines, and programs at the same time.
• Written Communication: Writing clear, accurate, regulator-ready documents.
• Teamwork: Building strong working relationships internally and with external partners.
• Flexibility: Adapting to changing regulations and business priorities.

PREFERRED QUALIFICATIONS:

• ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or ISO 13485/MDSAP Lead Auditor training.
• Regulatory Affairs Certification (RAC) or equivalent.

Note: We use AI-enabled tools to support certain aspects of our recruitment process.