QA Manager

2 weeks ago

Cambridge, Canada Virbac Full time

Experiencing together a unique human adventure
- Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
- Area of responsibility 1: Ensure Quality Systems are managed and sustained.

Main activities

This position is directly responsible for leading all Quality Assurance functions for Virbac Canada.

This person shall develop and sustain the functional Quality Assurance systems processes structure, including electronic systems managing documents, change controls, CAPA, deviations, APQRs, stability review, training, recalls, product release, and internal and external audits, to ensure ongoing GMP compliance is maintained.

This position is a working manager position that will be required to be actively engaged in problem solving, daily executions and project management.

Identifies and presents evidence of quality and compliance risks to Virbac North America QA Management and General Manager of Canada as they appear.

Expected results: Defined QA operating structure to ensure oversight of all assigned responsibilities

Area of responsibility 2: Develop and managed the product and material disposition and release system

Main activities

Qualified Person designee performing batch release.

Develop and sustain a GMP system with Quality review of all finished good releases.

Perform Quality Assurance activities relating to Third Party Manufacturing / Warehousing

Expected results: A functioning disposition system supported by SOPs and personnel that meets all regulatory requirements

Area of responsibility 3: Regulatory Compliance and Inspections

Main activities

Responsible for leading and achieving successful outcomes of Health Canada inspections, inspections by other GMP regulatory authorities, and GMP customer audits.

Provide required documentation to support regulatory body requests (inspection responses, incomplete letters, review questions and investigation progress).

Expected results: Successful outcomes of inspections and audits

Area of responsibility 4: Performance

Main activities

Review and manage QA operations to look for opportunities for improving throughput and efficiencies positively impacting product release timing. Use data to look for areas of improvement.

A thorough understanding of the gaps within the operational system and define steps for improvement

Focus on standardizing all operations in the interest of improving the operating compliance and performance standards.

Expected results: The Quality Assurance group contributes effectively to the goals of Virbac Canada

Area of responsibility 5: Team Management

Main activities

Manage activities of direct reports by that fulfill the group’s roles, and provides both primary and secondary responsibilities for all activities

Creating individual development programs based on individual needs

Working collaboratively with all internal/external business partners and key stakeholders to assess project deliverables or project challenges to provide input on solutions utilizing strong interpersonal, influencing, and negotiating skills.

Expected results: Ensures project objectives are communicated to proper levels of the organization. Additionally ensure all escalated issues are resolved to ensure timely completion of the project. Create formal documented development program for direct reports

Requirements (Diploma and experience)

Must hold a Canadian University degree, or a degree recognized as equivalent by the Canadian accreditation body, in a science related field. Bachelor's degree in Biology, Chemistry, Engineering or related field and experience

Generally 7+ years pharmaceutical quality, with a preference for Veterinary Pharma experience and 12+ years in the pharmaceutical industry

Must meet the requirements for being the Senior Person in Charge (SPIC) and/or Responsible Person in Charge (RPIC) per Health Canada’s Precursor Control Regulations.

**Skills**:
Demonstrated skill in effective team building, communicating with other departments, customers, employees at all levels of the organization.

Demonstrated ability to manage projects and influence individuals outside of reporting structure.

Demonstrated experience in managing people

Virbac provides numerous career opportunities, thanks to t

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