Quality Systems Manager
Bayshore HealthCare
Date: 3 weeks ago
City: Markham, ON
Contract type: Full time
Job Summary
Reporting to the Associate Director - Scientific Affairs, Quality and Risk Management, the Manager, Quality
Systems is responsible for overseeing the development, validation, implementation, adoption and
maintenance of centralized Quality Systems across the division and proactively manage risk through the
implementation of risk mitigation and minimization strategies.
Duties And Responsibilities
Leads the development, validation, training, launch and adoption of Centralized Quality Systems -
Document Management System (DMS), Quality Management System (QMS) and Learning
Management System (LMS) across the division.
Manages Quality System enhancements, system change controls, validation and roll out to support
evolving regulations and business needs.
Oversees and reviews validation of new and existing computerized systems for compliance with
company SOPs, 21 CFR Part 11, GAMP 5, and related regulatory requirements.
Manages Quality Systems – DMS, QMS, and LMS operationally and ensures smooth operations.
Leads and oversees the development of Operating Procedures (SOPs/WIs), Document Review and
Approval Flow, Change Control Impact Assessment, and Training Assignment.
Maintains the BSRx Quality Manual for procedural updates and audit readiness.
Reviews and approves Quality Agreements with pharmaceutical clients and/or third-party
subcontractors.
Oversee Vendor Qualification and Requalification process, assess the risk and approve
subcontractors from a quality standpoint.
Leads audit readiness and supports internal and external audits/inspections – ISO and Pharma
Manufacturer audits, Health Canada and College of Pharmacy inspections.
Monitors ISO and Health Canada regulatory and quality requirements and proactively adapt the
internal processes to meet the changing regulations.
Risk Identification and Mitigation: Establishes a proactive approach to risk management. Identifies
potential risks associated with our operating environment and related quality systems and
mitigates/eliminates risk with innovative and cost-effective solutions.
Develops and monitors quality metrics, including quality event trending and presents data for
management review for risk minimization strategies.
Collaborates with internal and external teams in addressing quality events/deviations and identifies
approaches to reduce/eliminate re-occurrence and associated risk with effective CAPA planning and
implementation.
Leads Quality 101 Education Sessions – Break silos and educate the teams to think of quality from
the get-go and build quality into new systems and processes.
Qualifications
Graduate or Professional degree in a scientific discipline is required. Master’s degree is preferred.
Post-graduate certification in Regulatory Affairs and Quality Operations is required.
Minimum of five (5) years of experience in the Pharma/Medtech/Life Sciences sector including two
Experience in a healthcare environment is a plus.
In-depth understanding of GxP regulations, including Good Manufacturing Practices (GMP), Good
Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), Medical Device Regulations and
ISO 9001 requirements.
Good understanding of FDA 21 CFR Part 11, GAMP 5 and other GxP systems regulatory validation
principles and ISO standards to be effective in this position.
Knowledge of College of Pharmacy regulations provincially is an asset.
Certification from ASQ or other relevant quality organizations is preferred.
Additional Skills
Proven ability to lead collaboration, thrive and enable success in a cross-functional environment.
Exhibit leadership conduct with high standards, professionalism, and ethics.
Able to raise the bar for quality and compliance and manage conflict and challenging conversations
in a constructive and transparent way.
Ability to grasp the essence of issues, deal comfortably with ambiguity, and make high-quality
decisions quickly.
Effective and approachable people leader - ability to lead, manage, and grow a diverse team.
Ability to successfully coach, mentor, and provide ongoing quality and compliance education.
Demonstrate the following core values: patient focus, transparency, respect, integrity, courage,
accountability, development, and teamwork
Primary Location
ON-Markham
Reporting to the Associate Director - Scientific Affairs, Quality and Risk Management, the Manager, Quality
Systems is responsible for overseeing the development, validation, implementation, adoption and
maintenance of centralized Quality Systems across the division and proactively manage risk through the
implementation of risk mitigation and minimization strategies.
Duties And Responsibilities
Leads the development, validation, training, launch and adoption of Centralized Quality Systems -
Document Management System (DMS), Quality Management System (QMS) and Learning
Management System (LMS) across the division.
Manages Quality System enhancements, system change controls, validation and roll out to support
evolving regulations and business needs.
Oversees and reviews validation of new and existing computerized systems for compliance with
company SOPs, 21 CFR Part 11, GAMP 5, and related regulatory requirements.
Manages Quality Systems – DMS, QMS, and LMS operationally and ensures smooth operations.
Leads and oversees the development of Operating Procedures (SOPs/WIs), Document Review and
Approval Flow, Change Control Impact Assessment, and Training Assignment.
Maintains the BSRx Quality Manual for procedural updates and audit readiness.
Reviews and approves Quality Agreements with pharmaceutical clients and/or third-party
subcontractors.
Oversee Vendor Qualification and Requalification process, assess the risk and approve
subcontractors from a quality standpoint.
Leads audit readiness and supports internal and external audits/inspections – ISO and Pharma
Manufacturer audits, Health Canada and College of Pharmacy inspections.
Monitors ISO and Health Canada regulatory and quality requirements and proactively adapt the
internal processes to meet the changing regulations.
Risk Identification and Mitigation: Establishes a proactive approach to risk management. Identifies
potential risks associated with our operating environment and related quality systems and
mitigates/eliminates risk with innovative and cost-effective solutions.
Develops and monitors quality metrics, including quality event trending and presents data for
management review for risk minimization strategies.
Collaborates with internal and external teams in addressing quality events/deviations and identifies
approaches to reduce/eliminate re-occurrence and associated risk with effective CAPA planning and
implementation.
Leads Quality 101 Education Sessions – Break silos and educate the teams to think of quality from
the get-go and build quality into new systems and processes.
Qualifications
Graduate or Professional degree in a scientific discipline is required. Master’s degree is preferred.
Post-graduate certification in Regulatory Affairs and Quality Operations is required.
Minimum of five (5) years of experience in the Pharma/Medtech/Life Sciences sector including two
- years experience in a leadership role, with a focus on managing various aspects of Quality
Experience in a healthcare environment is a plus.
In-depth understanding of GxP regulations, including Good Manufacturing Practices (GMP), Good
Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), Medical Device Regulations and
ISO 9001 requirements.
Good understanding of FDA 21 CFR Part 11, GAMP 5 and other GxP systems regulatory validation
principles and ISO standards to be effective in this position.
Knowledge of College of Pharmacy regulations provincially is an asset.
Certification from ASQ or other relevant quality organizations is preferred.
Additional Skills
Proven ability to lead collaboration, thrive and enable success in a cross-functional environment.
Exhibit leadership conduct with high standards, professionalism, and ethics.
Able to raise the bar for quality and compliance and manage conflict and challenging conversations
in a constructive and transparent way.
Ability to grasp the essence of issues, deal comfortably with ambiguity, and make high-quality
decisions quickly.
Effective and approachable people leader - ability to lead, manage, and grow a diverse team.
Ability to successfully coach, mentor, and provide ongoing quality and compliance education.
Demonstrate the following core values: patient focus, transparency, respect, integrity, courage,
accountability, development, and teamwork
Primary Location
ON-Markham
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