The manager will ensure QA deliverables related to classified rooms and utilities qualification, filling line validation, and overall operational GMP readiness in accordance with cGMP regulations, company policies, and regulatory requirements, including Eudralex GMP Annex 1.
DUTIES AND RESPONSIBILITIES
Project phase – Design, Qualification & Commissioning
·Act as the QA lead in engineering projects involving aseptic filling line, isolator and cleanroom infrastructure.
·Ensure early QA involvement in design and risk assessments, embedding GMP, Annex 1 and data integrity principles into system architecture and process flow.
·Oversee and approve qualification activities (FAT/SAT, IOPQ), ensuring quality requirements are met prior to operational release.
·Lead the QA assessments of change controls and ensure traceability from design to execution.
·Drive quality risk management throughout the project lifecycle supporting a right first-time approach in commissioning and validation
·Support the development and approval of GMP documentation, including SOPs, master batch records and protocol required for the new process or equipment.
·Ensure Annex 1 alignment by integrating contamination control principles, Contamination Control Strategy elements and aseptic process simulation requirements into project deliverables.
·Represent the QA function in project meetings to ensure alignment with technical and regulatory expectations.
Operational phase – Aseptic Manufacturing Operations
·Lead the QA activities related to aseptic filling ensuring compliance with Annex 1 and GMP requirements.
·Ensure timely review and approval of SOPs, deviations, CAPAs, change controls and batch records, maintaining product release timelines and quality standards.
·Be the primary QA contact during regulatory inspections and internal audits, demonstrating mastery of aseptic quality systems and facility knowledge.
·Lead by example in the cleanroom environment and foster an aseptic mindset, supporting all team members in maintaining the highest standards of sterility assurance
·Analyze Quality KPIs, lead continuous improvement initiatives and escalate quality trends to management
·Support Inspection readiness activities and represent QA function for engineering and manufacturing related matters in Health Authorities inspections
·Collaborate with cross-functional teams, including production, engineering, and manufacturing sciences, to drive quality and operational excellence.
·Promote a culture of compliance and continuous improvement throughout the project lifecycle.
·Ensure all activities comply with safety requirements, company policies, and applicable regulations.
REQUIREMENTS
·Demonstrated experience in qualification, validation and GMP operations.
·Significant experience in aseptic process activities (experience in isolator technology is an asset). Candidates with equivalent relevant experience are encouraged to apply
·Extensive experience in Quality Assurance oversight of pharmaceutical manufacturing projects. Candidates with equivalent relevant experience are encouraged to apply.
·Academic degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering, or related field).
·Strong knowledge of cGMP and international regulatory requirements for facility qualification and process validation.
·Strong knowledge of Eudralex GMP Annex 1 and Sterility Assurance concepts.
·Strong analytical and problem-solving skills.
·Excellent verbal and written communication skills with a structured approach.
·Fluent in French (written and spoken); proficiency in English is an asset.
·Ability to work independently and collaborate with multidisciplinary teams.
The aforementioned activities can be delegated to the QA Manager Tech. Transfer, to the QA Manager Operations and Engineering and to the QA Associate Directors.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
