Position Title: Quality Excellence Lead (Systems, Operations and Compliance)
Location: Brampton, Ontario (On-Site)
Primary Work Location: Pickering, Ontario (On-Site)
Employment Type: Full-Time
Work Schedule: Monday to Friday | 9:00 AM – 5:30 PM
Salary Range: $80,000 - $100,000
Work Location Flexibility: The successful candidate will initially work from the Company's Head Office in Brampton. However, the primary work location may be changed to the Company's Pickering facility or another Company location based on business requirements and operational needs.
Company Description: Nanz Pharma is a globally respected Canadian healthcare company specializing in the development and manufacturing of medical devices, pharmaceuticals, and Natural Health Products (NHPs). With a strong focus on innovation, quality, and regulatory excellence, the organization is committed to delivering safe, effective, and affordable healthcare solutions that improve the quality of life for people around the world.
Driven by a culture of integrity, accountability, and continuous improvement, Nanz Pharma partners with customers, healthcare professionals, and communities to develop products that meet the highest global quality and compliance standards. The company's vision is to provide trusted healthcare solutions built on quality, innovation, and excellence, while fostering an environment where talented professionals can contribute to meaningful advancements in healthcare and long-term global growth.
Role Description
The Quality Excellence Lead (Systems, Operations and Compliance) is a strategic and operational leadership role responsible for overseeing Quality Operations, Quality Systems (QMS), Product Release, Regulatory Compliance, and Continuous Improvement across Medical Devices, Natural Health Products (NHPs), Pharmaceuticals, and Cosmetics.
Serving as the organization's quality authority, the incumbent will ensure that quality systems and operational processes remain compliant with applicable Health Canada regulations, MDSAP requirements, ISO 13485 principles, GMP, GDP, Site Licence requirements, Medical Device Licensing requirements, and other applicable domestic and international regulatory standards.
As a company operating as both a manufacturer and Contract Manufacturing Organization (CMO), the role will provide quality oversight for internally developed products as well as customer-owned products manufactured under commercial agreements. The incumbent will work closely with Regulatory Affairs, Operations, Supply Chain, Manufacturing, Product Development, Procurement, Commercial teams, customers, suppliers, and third-party service providers to support regulatory approvals, product registrations, technology transfers, new product introductions, product launches, customer requirements, supplier qualification, and inspection readiness.
The role requires a quality leader capable of balancing regulatory and compliance requirements with operational excellence, business continuity, customer expectations, and sustainable business growth across multiple regulated product categories and markets.
Preferred Industry Experience:
Demonstrated quality leadership experience within the Medical Device industry is strongly preferred. Experience within Natural Health Products (NHPs) and/or Pharmaceuticals is also highly desirable and considered a valuable asset.
Key Responsibilities
- Lead Quality Operations, Quality Systems (QMS), Product Release, Compliance, and Continuous Improvement programs across Medical Devices, Natural Health Products (NHPs), Pharmaceuticals, and other regulated product portfolios.
- Serve as the designated Quality Authority for batch record review, product disposition, final product release, and quality risk-based decision-making.
- Provide leadership and oversight to the QA team while owning and continuously improving the Quality Management System, including CAPA, Deviations, Investigations, Change Control, Document Control, Training, Complaint Management, Risk Management, ALCOA+, and Management Review processes.
- Ensure compliance with MDSAP, ISO 13485, GMP, GDP, Medical Device Regulations, Natural Health Products Regulations, Food and Drug Regulations, Cosmetic Regulations, Site and Establishment Licensing requirements, and applicable international regulatory standards.
- Lead internal, customer, supplier, certification, and regulatory audits and inspections, serving as the primary quality liaison and ensuring effective remediation, CAPA implementation, effectiveness verification, and sustained inspection readiness.
- Provide quality oversight for validation and qualification activities, including Process Validation, Cleaning Validation, Equipment Qualification (IQ/OQ/PQ), Computer System Validation (CSV), and ongoing process performance monitoring.
- Provide quality oversight and support for customer onboarding, quality agreements, technical transfers, contract manufacturing, product commercialization, customer change notifications, product lifecycle management, and regulatory support activities.
- Manage supplier and third-party quality programs, including qualification, quality agreements, risk assessments, audits, performance monitoring, approval, and requalification of suppliers, contractors, consultants, contract laboratories, warehousing, distribution, and other GxP-regulated service providers.
- Partner with Regulatory Affairs to support product registrations, NPN applications, Medical Device Licence applications, regulatory submissions, amendments, renewals, market authorizations, and licensing requirements.
- Lead investigations related to deviations, complaints, OOS, OOT, non-conformances, and other quality events using root cause analysis and risk-based methodologies, ensuring timely and effective corrective and preventive actions.
- Ensure effective complaint management, vigilance reporting, adverse event reporting, market surveillance, product withdrawals, recalls, and Field Safety Corrective Actions (FSCA), where applicable.
- Develop, monitor, trend, and report Quality KPIs and metrics, including compliance performance, audit outcomes, supplier quality, training effectiveness, CAPA effectiveness, complaint trends, release cycle times, and Right-First-Time performance.
- Foster a culture of quality, compliance, accountability, customer satisfaction, patient safety, operational excellence, and continuous improvement throughout the organization.
Key Requirements
- Bachelor's degree in Pharmacy, Chemistry, Microbiology, Life Sciences, or a related scientific discipline.
- Minimum 7+ years of progressive Quality, Compliance, or Regulatory leadership experience within Medical Devices, Natural Health Products, Pharmaceuticals, or another highly regulated industry.
- Demonstrated expertise in MDSAP, ISO 13485, GMP, GDP, QMS, Change Control, Risk Management, Complaint Handling, Internal Audits, and Regulatory Compliance systems.
- Strong knowledge of Health Canada Medical Device Regulations, Natural Health Products Regulations, Food and Drug Regulations, Cosmetic Regulations, and applicable international regulatory frameworks.
- Proven experience supporting product registrations, Medical Device Licences, NPNs, Site Licences, Establishment Licences, regulatory submissions, and market authorizations in partnership with Regulatory Affairs.
- Extensive experience in supplier qualification, vendor management, quality agreements, contract manufacturing oversight, third-party auditing, and external partner governance.
- Strong technical understanding of manufacturing operations, process validation, equipment qualification (IQ/OQ/PQ), cleaning validation, product release, importation, exportation, and distribution systems.
- Proven ability to lead Quality teams, influence senior stakeholders, and drive cross-functional quality and compliance initiatives.
- Strong leadership, project management, analytical, root cause investigation, and problem-solving skills, with the ability to balance compliance obligations and business objectives.
- Exceptional communication and executive reporting skills, including experience presenting quality risks, Quality KPIs, compliance status, audit findings, and continuous improvement initiatives to senior leadership.
Qualifications
- Strong foundation in Quality Assurance, Quality Management Systems, Regulatory Compliance, and Quality Operations.
- Demonstrated experience designing, implementing, maintaining, and continuously improving Quality Management Systems.
- Strong knowledge of Medical Device, NHP, Pharmaceutical, and Cosmetic regulatory requirements.
- Proven experience with audits, inspections, CAPA, deviations, investigations, change controls, complaints, risk management, and product release.
- Experience working within a Contract Manufacturing Organization (CMO) environment is considered an asset.
- Strong understanding of supplier quality management, quality agreements, third-party oversight, and customer quality requirements.
- Demonstrated ability to use quality data, KPIs, and metrics to support risk-based decision-making and operational improvement.
- Excellent communication, stakeholder management, leadership, and relationship-building capabilities.
- Ability to work on-site in Brampton, ON, with flexibility to support the Company's Pickering facility and other locations as required.
- Ability to work effectively in a fast-paced, cross-functional, highly regulated healthcare and manufacturing environment.
Hiring Process:
- Nanz Pharma does not use AI in candidate screening or selection - all hiring decisions are human-led.
- Interviewed candidates will be informed of hiring decisions within 45 days.
Why Join Us
Join a collaborative, global team helping build the future of pharmaceutical manufacturing, medical devices, and healthcare innovation. Play a key role in strengthening quality systems, ensuring regulatory compliance, supporting customer and product growth, and building a culture of quality and operational excellence across a growing organization.
