Quality Assurance Manager
تفاصيل الوظيفة
We’re hiring! Agrisan, a trusted specialty chemical manufacturer providing chemical solutions to the Agricultural and Veterinary point-of-care industries, is excited to welcome a Quality Assurance Manager to our team. Our expertise spans Animal Health & Hygiene, Custom Toll Blending, and Cleaning and Sanitation, providing quality solutions across all key sectors. In this role, reporting to the Managing Director, you will oversee our Quality Management Systems, ensuring compliance with GMP standards in line with Health Canada regulations and other government and industry requirements. We’re looking for an accomplished Quality Assurance professional with experience in Pharmaceutical or Veterinary Science product manufacturing. A degree in Chemistry or Chemical Engineering is essential, along with expertise in GMPs (particularly GUI-0001), progressive Quality Assurance management systems, and Health Canada Class A Precursor requirements. Strong leadership and the ability to foster collaboration and teamwork are key, as we pride ourselves on maintaining a culture of innovation and open communication. If this sounds like you, we’d love to connect! What will you do?
- Responsible for all laboratory activities at Agrisan and their compliance with Agrisan’s Quality Management systems.
- Responsibility for overseeing all regulatory and licensing activities at Agrisan.
- Ensure the Quality and Regulatory teams provide support to the Operations team in the development of compliant activities and systems.
- Develop and deliver effective relevant training to Quality & Regulatory team. The Quality Manager is responsible for delegating quality and regulatory duties to persons who are qualified while remaining accountable for those duties.
- Promote and maintain a strong safety culture within the lab and facility, upholding safety protocols and environmental protection guidelines.
- Maintain inspection readiness.
- Lead internal and external audits. Facilitate regulatory inspection activities and responses.
- Oversee quality risk assessments and facilitate corrective and preventative action plans.
- Lead non-conformance investigations and collaborate with stakeholders to establish and carry-out corrective and preventative action plans.
- Oversee laboratory studies for R&D activities such as product and method development. Includes completion of annual SRED reporting.
- Provide quality/compliance oversight and recommendations to site personnel for investigations, change controls, protocols, reports, area releases, project planning and site procedures
- Approve and assess GMP compliance of SOPs, processes, validation studies, change requests, and calibration documentation.
- Oversee release of drug product to market and/or determine disposition of product, raw materials and/or components.
- Negotiate and ensure compliance with customer quality agreements. Provide Senior Managing Director with insight on cost and process impacts.
- Provide oversight of Agrisan’s GMP document management system.
- Support optimization of laboratory processes to improve output, reduce/eliminate costs, and enhance overall operational efficiency.
- Foster a culture of continuous improvement and accountability.
- Evaluate and recommend opportunities for improvements in alignment with strategic priorities.
- Along with the Senior Managing Director, develop annual plans, budgets, and results measurements; allocating resources; reviewing progress; and making mid-course corrections in collaboration with Agrisan Management Group.
- Capital expenditure (CAPEX) requests to be supported by business case, including ROI.
- Develop and communicate key performance goals for the Quality & Regulatory teams.
- Advise Senior Managing Director with input on resource allocation, including personnel, equipment and materials, to meet laboratory targets and timelines.
- Oversee hiring and talent development programs for Quality & Regulatory teams in alignment with Agrisan’s values.
- Engage and deliver performance management to members of team, including annual goal and objective setting, regular and ongoing development and engagement, along with mid and end-of-year performance reviews.
- Support organizational changes and lead Quality and Regulatory teams accordingly, with clearly defined expectations and accountabilities.
- Serve as a culture champion for Agrisan and CG Wellington.
- As a member of the Agrisan Management Group, engage with peers and colleagues in broader strategic company initiatives, including but not limited to: strategic priorities and planning, projects, talent development, mentoring, open dialogue, and support as necessary.
- Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; and benchmarking state-of-the-art practices.
- Build influential and collaborative internal cross-functional relationships and steward excellent relationships with internal and external stakeholders
- Bachelor’s university degree; from a Canadian university or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related field (e.G. chemistry, chemical engineering) and have a minimum of 5 years of related work experience in industrial, pharmaceutical manufacturing.
- Must meet Health Canada Class A Precursor requirements for “Responsible Person in Charge.”
- Knowledge of GMPs (GUI-0001), Quality systems, OHSA and TDG.
- Experience in leading and managing cross-functional teams.
- Experience in conducting performance evaluations.
- Great strategic and creative thinking skills.
- Demonstrated execution of goal-setting responsibilities.
- Strong analytical skills.
- Excellent leadership, communication, interpersonal, and customer service skills.
- Self-motivated and driven to succeed and lead the Company to maximum productivity and efficiency.
- Demonstrated capabilities in change management, conflict management
- Strong proficiency with Microsoft Office Suite.
- Strong attention to detail and ability to execute with excellence
- Outstanding team player and commitment to the greater good.
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