Operational Quality Manager

One of Quanta’s world leading radiopharmaceutical clients are looking for an Interim Head of Operational Quality to join their team in Southern Paris on an initial 6-month contract.

The successful candidate will be responsible for managing a team of Engineer’s and Pharmacist’s, as well as having day to day oversight and management of the quality management systems on site. They will be responsible for the compliance and quality of the marketed products.

Role:
Management of the Operational Quality Assurance team (12/14 people)
o Accompanying employees and evaluating their results
o Sharing company's challenges and operational impacts
o Set up, manage and communicate on service indicators.
Deviations, OOS, claims, CAPA
o Dealing with deviations, OOS and claims and adjudicating quality impact
o Help to the define and implement CAPAs to avoid recurrence
Release of lots
o Ensure the release of batches of finished products from the site
o Manage batch file review by optimizing product flow
Product Quality Review
o Lead the production of product quality reviews
o Analyze product quality reviews to fuel continuous improvement
Documentation
o Approve procedures, protocols/validation/qualification reports,
o Optimize site quality documentation (operating procedures, lot records, etc.)
Quality Risk Management (in connection with Quality Risk Management Manager)
o Lead the quality risk management program
o Controlling the risks identified in relation to the services concerned
Infertility insurance (in connection with the infertility insurance manager):
o Validate the rules for mastering the safety assurance of production workshops
o Validate the environmental control program
o To ensure the development of the site's knowledge of infertility insurance
Audits and inspections
o Participate in self-inspections, customer audits and quality inspections.
Projects/changes
o Participate in assigned site quality improvement projects
o Contributing to the mastery of change

Requirements:
• Pharmacist with at least 15 years of mandatory professional experience in the pharmaceutical industry, including Quality Assurance and sterile production
• Mastery of GMP Quality and CGMP repositories and knowledge of aseptic processes
• Previous management experience
• Experience in deviation investigations, CAPA’s, batch release etc.
• Dynamic and adaptable
• Fluent in both French and English



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