Job Description

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 RESPONSIBILITIESxe2x96xaa 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.
xe2x96xaa Manages Quality System enhancements, system change controls, validation and roll out to support
evolving regulations and business needs.
xe2x96xaa 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.
xe2x96xaa Manages Quality Systems xe2x80x93 DMS, QMS, and LMS operationally and ensures smooth operations.
xe2x96xaa Leads and oversees the development of Operating Procedures (SOPs/WIs), Document Review and
Approval Flow, Change Control Impact Assessment, and Training Assignment.
xe2x96xaa Maintains the BSRx Quality Manual for procedural updates and audit readiness.
xe2x96xaa Reviews and approves Quality Agreements with pharmaceutical clients and/or third-party
subcontractors.
xe2x96xaa Oversee Vendor Qualification and Requalification process, assess the risk and approve
subcontractors from a quality standpoint.
xe2x96xaa Leads audit readiness and supports internal and external audits/inspections xe2x80x93 ISO and Pharma
Manufacturer audits, Health Canada and College of Pharmacy inspections.
xe2x96xaa Monitors ISO and Health Canada regulatory and quality requirements and proactively adapt the
internal processes to meet the changing regulations.
xe2x96xaa 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.
xe2x96xaa Develops and monitors quality metrics, including quality event trending and presents data for
management review for risk minimization strategies.
xe2x96xaa 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.xe2x96xaa Leads Quality 101 Education Sessions xe2x80x93 Break silos and educate the teams to think of quality from
the get-go and build quality into new systems and processes.QualificationsQUALIFICATIONS
xe2x96xaa Graduate or Professional degree in a scientific discipline is required. Masterxe2x80x99s degree is preferred.
xe2x96xaa Post-graduate certification in Regulatory Affairs and Quality Operations is required.
xe2x96xaa Minimum of five (5) years of experience in the Pharma/Medtech/Life Sciences sector including two
(2) years experience in a leadership role, with a focus on managing various aspects of Quality
Assurance and GxP Quality Systems.
xe2x96xaa Experience in a healthcare environment is a plus.
xe2x96xaa 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.
xe2x96xaa 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.
xe2x96xaa Knowledge of College of Pharmacy regulations provincially is an asset.
xe2x96xaa Certification from ASQ or other relevant quality organizations is preferred.
ADDITIONAL SKILLS
xe2x96xaa Proven ability to lead collaboration, thrive and enable success in a cross-functional environment.
xe2x96xaa Exhibit leadership conduct with high standards, professionalism, and ethics.
xe2x96xaa Able to raise the bar for quality and compliance and manage conflict and challenging conversations
in a constructive and transparent way.
xe2x96xaa Ability to grasp the essence of issues, deal comfortably with ambiguity, and make high-quality
decisions quickly.
xe2x96xaa Effective and approachable people leader - ability to lead, manage, and grow a diverse team.
xe2x96xaa Ability to successfully coach, mentor, and provide ongoing quality and compliance education.
xe2x96xaa Demonstrate the following core values: patient focus, transparency, respect, integrity, courage,
accountability, development, and teamwork

Bayshore HealthCare