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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in pharmaceutical quality management, regulatory compliance, and governance, with a strong focus on QMS oversight, pharmacovigilance, and cold-chain management within the French pharmaceutical landscape.
Highest-signal resume keywords
Pharmacist QualificationPharmaceutical Quality ManagementRegulatory CompliancePharmacovigilance OversightCold-Chain Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Management System (QMS)Good Distribution Practice (GDP)Change ControlCorrective and Preventive Actions (CAPA)AuditsDeviations ManagementSupplier QualificationProduct Quality ComplaintsBatch TraceabilityRegulatory Requirements
Soft Skills
Cross-Functional LeadershipCrisis ManagementCommunicationPrioritizationSound Judgement
Certifications & Qualifications
Registered Pharmacist with French Order of Pharmacists
Industry Keywords
Pharmaceutical GovernanceFrench Public Health CodeExploitant ResponsibilitiesEU Regulatory RequirementsMedical Information ProcessesPromotional ComplianceTraceable DocumentationPublic-Health Risk AssessmentInspection ReadinessQuality Risk Management
About the role
Key responsibilities & impact- Define and oversee the local pharmaceutical quality strategy and continuous improvement of the Quality Management System (QMS).
- Ensure pharmaceutical governance, quality oversight, inspection readiness and compliance across local and outsourced activities.
- Oversee deviations, CAPAs, change controls, quality complaints, supplier qualification, audits and quality risk management.
- Ensure quality training, documentation, management reviews and follow-up of inspections and regulatory commitments.
- Ensure pharmaceutical compliance across the French distribution network, including 3PLs, warehousing, transportation and cold-chain management.
- Oversee product quality, batch traceability, recalls, withdrawals, temperature excursions and distribution-related quality incidents.
- Ensure continuity of supply to the French market, including product shortages, safety stocks and shortage prevention and management plans (MITM/PGP).
- Coordinate with Group functions and external partners to manage and escalate supply and distribution risks.
- Oversee local pharmacovigilance compliance within the French Exploitant perimeter and governance of outsourced PV activities.
- Coordinate with the external RPV/LPPV provider, EU-QPPV, Global PV, MAHs and local stakeholders.
- Monitor PV compliance and escalation of significant safety issues, ensuring required safety measures and regulatory obligations.
- Oversee pharmaceutical and medical information processes, product quality complaints and pharmacovigilance cases.
- Ensure promotional activities and materials comply with French regulations, including healthcare professional interactions and promotional team training.
- Oversee local regulatory implementation, including marketing authorization changes, product information, packaging, artwork and mandatory French requirements.
- Monitor pharmaceutical regulatory developments and implement relevant changes.
- Lead the French Pharmaceutical Affairs function and supervise deputy/delegated pharmacists and external providers.
- Collaborate with General Management, Global Quality, Regulatory Affairs, Medical Affairs, Supply Chain and Group functions.
- Represent the company in pharmaceutical matters with French competent authorities and external stakeholders.
- Exercise the statutory responsibilities, decision-making authority and approvals of the Pharmacien Responsable under French regulations.
Requirements
What you’ll need- Pharmacist qualified and registered with the French Order of Pharmacists (Section B) as required for the PR appointment.
- Professional experience meeting Article R.5124-16 of the French Public Health Code; extensive experience in a pharmaceutical Exploitant and interactions with regulatory authorities.
- Minimum 10 years of relevant experience in the pharmaceutical industry, including pharmaceutical operations, quality management, regulatory compliance and pharmaceutical governance.
- Experience with GDP distribution and cold-chain requirements; sound understanding of EU GDP and relevant Benelux distribution arrangements.
- Deep knowledge of French pharmaceutical legislation (especially Exploitant/PR responsibilities), GxP, GDP, GVP oversight and relevant EU/French regulatory requirements.
- Sound judgement and independence in pharmaceutical decision-making, public-health risk assessment and timely escalation.
- Strong knowledge of QMS governance, deviations/CAPA, change control, complaints, recalls, audits, inspections, suppliers and product shortages.
- Ability to supervise outsourced local pharmacovigilance and medical information interfaces without conflating PR oversight with operational RPV responsibility.
- Proven management, cross-functional leadership, communication, prioritization and crisis management skills.
- Fluent in French, fully proficient in English is a must-have.
- Integrity, objectivity, confidentiality, attention to detail and ability to maintain complete traceable documentation.
Benefits
Comp & perks- Private Health Insurance (Mutuelle)
- Paid Time Off (CP/RTT)
- Work From Home (1 day/week)
- Training & Development
- Performance Bonus (on top of base salary)
