Location:
243 Consumers Road, Toronto, Ontario, M2J 4W8

Why this role is important?

Manager, Quality Assurance

Reporting directly to Senior Director, Quality Assurance and Regulatory Affairs, the incumbent will be responsible for quality and regulatory management oversight of the enterprise audit / inspections program, supplier quality management program, risk management program and quality excellence initiatives in compliance with Canadian laws and standards and Health Canada regulations and guidelines.

Duties:

Working closely with internal stakeholders, external suppliers, and regulatory agencies, the Manager, Quality Assurance will support the establishment and maintenance of the quality systems and standards for audits and inspections, supplier quality management, risk management and quality excellence/ continuous improvement initiatives.

• Supplier Quality Management:

• Manage the enterprise supplier quality management program, acting as the lead for:

• Qualification of suppliers/ vendors

• Creation, Approval, Revision and Maintenance of Quality Agreements

• Management oversight of Supplier Change Notifications, ensuring that supplier changes are appropriately communicated and assessed for impact to enterprise Quality Management Systems.

• Establishment of enterprise Supplier Audit schedule

• Lead auditor for all Supplier audits, including development of the audit plan, audit execution, final report, tracking of related supplier responses/ CAPA and associated closure

• Engaging key stakeholders and subject matter experts for supplier audit support (as required)

• Support key stakeholders on all matters associated with supplier product quality issues

• Audits & Inspections Management:

• Manage the enterprise audits & inspections program, acting as the lead for:

• Establishment of enterprise audit schedule for self-inspection of the QMS, internal audits of enterprise owned sites (e.g., CPS), and external audits (e.g., distribution centers)

• Lead auditor for all self-inspection, internal and external audits, including development of the audit plan, audit execution, final report, tracking of related responses/ CAPA and associated closure

• Engaging key stakeholders and subject matter experts for supplier audit support (as required)

• Support customer audits of various enterprise sites (as required)

• Supports audits of Sanis cross-license partners and foreign site audits with Director, Quality Assurance (Sanis) (as required)

• Risk Management:

• Manage the enterprise risk management process, ensuring that all known/ potential risks to the enterprise Quality Management System compliance are captured, escalated, and tracked through to closure.

• Document/Record Management:

• Identify and review government, regulatory and corporate policies to ensure all assigned procedures are current and meet requirements

• Identify compliance gaps, develop, and implement plans to address compliance gaps

• Update/Develop SOPs ensuring timely implementation

• Manage the review, maintenance, and organization of all quality documents

• Personnel Training:

• Conduct personnel training on GMPs, SOPs and audit/ inspection Dos & Don'ts

• Manage timely completion of personnel training and training records

• Management Review Meetings:

• Report on compliance status of enterprise audits & inspections and supplier quality management programs

• Report on status of quality goals and metrics

• Project Management:

• Support/Lead quality excellence and continuous improvement initiatives as assigned

• Other:

• Act as a back-up to support compliance and product release of drug importation activity for OTC DIN products

• Support of other Healthcare businesses, as required

• Perform other Quality duties, as assigned

• Travel to various SOM sites and vendor sites is required to support execution of audit schedule(s)

Skills and Experience:

This position requires an advanced level of initiative and judgment in order to organize and prioritize tasks, workload and projects. A strong ability to influence while maintaining courtesy, tact and diplomacy is required in dealing with internal and external stakeholders in every day working relationships.

• Minimum 7+ years working in the GMP pharmaceutical industry in Quality Assurance

• Must have a Bachelor of Science degree (or Canadian Equivalent)

• Solid experience in quality audit management, including regulatory inspections (e.g., Health Canada); Quality Auditor Certification (e.g., ASQ) is preferred

• Strong technical writing and organization skills

• Strong understanding and sound interpretation of College of Pharmacist, Health Canada GMP and other related guidelines, Medical Device Regulations, Natural Health Product Regulations, the Narcotic Controlled Regulations, Controlled Drugs and Substances Act, Benzodiazepine and Other Targeted Substances Regulations, Precursor Control Regulations, Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances)

• Strong Quality and risk-based approach decision making and business acumen

• Regulatory Affairs, Pharmacovigilance, Supply Chain and Logistics experience, an asset

Additional Skills and Experience:

• Requires an ability to apply concepts and theories to improve functions or units.

• Requires specialized interpersonal skills to resolve situations with colleagues where there may be some level of conflict, stress or uncertainty.

• Provides solutions by using imaginative approaches where constructive and critical thinking and innovation are required.

• Utilizes decision making skills to achieve specific organizational objectives with consideration given to their impact on other work groups.

• Adaptable to set and prioritize work with varying exceptions. Able to work with diverse personalities and styles.

• Advanced understanding of Quality Assurance policies and procedures in a manufacturing and supply chain/logistics environment

• Ability to handle sensitive issues requiring timely completion of documentation to control deficiencies and expedite product dispositions

• Sound knowledge of compliance and regulatory components, auditing skills, and quality systems

• Interpret Health Canada GMPs and other Guidelines and regulations, PIC/s, corporate policies/standards to determine SDM position regarding quality processes, compliance requirements

• Maintaining quality and patient safety first while recognizing the importance of good business decisions

• Computer skills to produce effective reports, documents, spreadsheets and presentations.

• Communicates with clarity, verbally to conduct personnel training and in one on one or group situations, or over the telephone.

• Communicates well in writing by composing clear documents

• Able to work with minimal of supervision.

• Proficiency in all Microsoft Office applications (especially Excel, Word and PowerPoint)

Employment Type:
Full time

Type of Role:
Regular

Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application.

Hiring Range / Échelle salariale à l'embauche :

$80,000.00 - $110,000.00 / 80.000,00$ - 110.000,00$ (per year / par an)

A candidate's experience and knowledge as well as the geographical region in which the position is located may be factored into the pay a candidate receives for this position. This posting is for an existing vacancy. The Company uses artificial intelligence for the purpose of screening, assessing and/or selecting applicants for this position. / L'expérience et les connaissances d'un candidat ainsi que la région géographique dans laquelle le poste est situé peuvent être prises en compte dans la rémunération qu'un candidat reçoit pour ce poste. Cette offre d'emploi concerne un poste vacant existant. L'entreprise utilise l'intelligence artificielle dans le but de filtrer, d'évaluer et/ou de sélectionner les candidats à ce poste.

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