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Head of Global CMC Research and Development - Vaccine
Sanofi —Toronto, ON
Strong network within the vaccine manufacturing and regulatory community including CMOs, regulatory agencies, and industry consortia.
De 232 500,00 $ à 364 833,33 $ par an
il y a 11 jours

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Position Summary

We are seeking a Laboratory Director to lead our newly built state of the ART Facility running 100% embryoscope technology. This individual will be responsible for the overall technical, operational, regulatory, and quality performance of the laboratory, ensuring outcomes meet or exceed industry benchmarks and clinical standards.
This is a senior leadership role requiring deep technical expertise in assisted reproductive technologies (ART), strong regulatory acumen, and demonstrated success building and leading high-performing laboratory teams.

Reporting Structure

Reports to: TFP’s Vice President, Laboratory Operations
Ensures open communication lines with Medical Director and Clinic Manager, functioning as an operational triad for clinic performance.

Role Specific Scope

Technical
- Performs and validates highly complex ART procedures.
- Signs off all laboratory staff competency.
- Coordinates patient treatment planning with physicians and clinic/nurse manager.
Regulatory & Accreditation
- Ensures compliance with all federal, provincial/state, and accrediting bodies.
- Maintains continuous inspection readiness.
- Oversees proficiency testing programs.
- Ensures corrective action documentation and follow-up.
Quality & Risk
- Leads QA/QC programs.
- Participates in risk management committee.
- Investigates and documents laboratory incidents.
Operations & Financial Stewardship
- Develops and manages laboratory budgets.
- Recommends capital equipment acquisition.
- Oversees inventory cost control.
Human Resources Authority
- Recruitment and hiring recommendation (with HR/VP, Laboratory Operations).
- Performance reviews in line with HR policies.
- Progressive discipline (in coordination with HR).
- Creation of training programs.
- Schedule oversight in compliance with employment legislation.
Executive Leadership
- Participates in Executive Committee.
- Establishes laboratory vision and organizational values.
- Builds high-performance laboratory culture.
- Drives continuous improvement and innovation.

Experience Requirements

Minimum Masters degree with preference for PhD.
At least 5 years experience as embryologist
CFAS certification as embryologist
CFAS certification as Laboratory Director (to be obtained within 2 years if not already)
Demonstrated leadership ability and exemplary performance record.