Position : HEAD OF QA/COMPLIANCE: OM1 TO OM2 TRANSFER PROJECT

(Temporary 24 months)

1. JOB OBJECTIVES

Ensure that activities carried out as part of the transfer of production from the OM1 line to OM2 meet quality and GMP compliance requirements.

2. PRIMARY FUNCTIONS

When moving products from OM1 to OM2, the owner is responsible for:

• Review and approve product transfer strategies and ensure that compliance requirements (e.g., new bioburden standard, validation of microbiological methods, process validation, etc.) are met.
• Review and approve all procedures that will be modified.
• Participate in the risk analysis of transferred products (APT) and obtain Quality approval.
• Participate in the creation of master manufacturing files and obtain Quality approval.
• Review non-conformities and OOS and obtain Quality approval.
• Review validation protocols and reports and obtain Quality approval.
• Review batch records (including analysis results and related documents) concerning the acceptance (or rejection) of transferred batches that will be marketed.
• Anticipate and regularly communicate to the project team any compliance issues related to product transfer for remediation.
• Escalate any compliance issues and risks related to product transfers to the Vice President of Quality and the project sponsor.
• Keep up to date on regulations applicable to your activities.
• Perform any other related tasks deemed relevant to the position.

3. REQUIREMENTS AND SKILLS

• Bachelor's degree in science or any other relevant field of study.
• Minimum of 10 years of experience in quality assurance in the pharmaceutical industry in quality operations and validation.
• Excellent knowledge of GMPs and Canadian and US regulations.
• Motivational leadership.
• Strong analytical skills and a global vision.
• Ability to make decisions and assess compliance risks.
• Negotiation and communication skills.
• Good ability to manage high-stress situations.
• Effective time and priority management.
• Bilingualism (French and English) in spoken and written communication.