Manager Supplier Quality
PharmEng Technology is currently seeking a Manager Supplier Quality
a project in Ontario, Canada The position is available immediately conditional of a successful interview
- Cross functional teams to support on boarding of new suppliers, service providers and materials as required.
- Define and manage the processes for qualification of suppliers and service providers e.g. managing supplier change notifications, supplier deviations, specifications, etc.
- Ensure Quality Technical Agreements (QTAs) are in place, as required
- Liaise with the vendor auditors, when required for QTAs and participate/support vendor audits, as required
- Provide risk management support as required
- Manage Change Controls
- Provide risk management support to ensure action plans are on track and risk assessments are performed as required 10%
- Lead assessment of Supplier Change Notifications and CCRs within required timeframes and ensure required deliverables are completed 20%
- Maintain the Quality Third Party Database (Phenix) for materials and services used by SPL 10%
- Manage supplier deviations to ensure timeliness and compliant investigation 5%
- Lead creation, review and approval of specifications for Supplier Quality 40%
- Support creation, review and approval of procedures for Supplier Quality 5
- Support audit of suppliers and service providers to ensure that the manufacturing of raw materials, consumables, manufacturing aids and packaging components meets GMP/ISO requirements. 10%
- Responsible to ensure that materials/services are of required quality and meet appropriate quality standards.
- Works independently under minimal supervision and direction to complete planned activities e.g. ensure priorities are aligned
- The position collaborates with both internal and external stakeholders so situational awareness is important.
- The Manager, Supplier Quality is expected to interact with Global Quality Auditors as required.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted
- Minimum Bachelor of Science Degree, specializing in either Chemistry, Biochemistry
- At least 5 years of industrial experience in the Pharmaceutical/Biotech Sterile Manufacturing or Quality environment.
- Experience in various GMP pharmaceutical/biological manufacturing such as testing, facilities, validation and utilities.
- Experience with electronic database, document and information management (e.g. Documentum, SAP, Excel, etc.)
- Proficiency in computer software applications, i.e.: Microsoft Office
- Document, information and data organization skill
- Strong understanding of applicable GxPs, as relates to the assurance of quality for suppliers, service providers and commercial manufacturing
- Strong verbal and written communication and technical writing skills to prepare accurate, clear and comprehensive documents
- Situational awareness and the ability to make decisions regarding prioritization of work
- Ability to work in cross-functional teams and collaboration with a diverse team of stakeholders (e.g. internal/ external, management and operational levels) to ensure quality and compliance is maintained/established; strong collaboration, communication and negotiation skills are essential for this position, as the person needs to work with different stakeholders: internal stakeholders in addition to external ones i.e. suppliers and service providers.
- Basic understanding of biological manufacturing processes, validation (e.g., process, facility/equipment)
- Ability to interact with Global Quality auditors during inspections