Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. Galderma is a leader in the research and development of scientifically-defined and medically-proven solutions for the skin. Partnering with health care practitioners around the world to meet the skin health needs of people throughout their lifetime, the company aims to change the way the world thinks about skin health.
Pharmacovigilance Quality Assurance Manager
Your mission:
In this challenging and dynamic role, the ‘’Pharmacovigilance Quality Assurance Manager’’ will ensure the deployment and execution of the QA Management System dedicated to Galderma Pharmacovigilance.
Your main tasks:
• Quality Management and Systems
- Propose and ensure harmonized implementation of a Galderma fit for purpose and sustainable PV quality strategy in line with the company goals, expectations and values
- Recommend, implement and maintain PV Quality Management systems and processes that are aligned with the business needs and the regulatory status of the Galderma portfolio products (drugs, cosmetics and medical devices)
- Ensure the development of innovative quality methodologies supporting the continuous improvement of the PV Quality Management system
- Ensure appropriate documentation of the PV quality system by overseeing the development, on-going improvement and implementation of the quality documents related to this system
- Conduct regular quality reviews of the PV quality system including the analysis of Key Performance Indicators to identify trends and signals and support prevention/remediation plans
• Audits and Inspections
- Manage a process and risk based approach independent quality evaluation of Corporate PV systems, affiliates and external partners
- Implement Audits, Mock Inspections, Assessments programs to support this evaluation approach and ensure appropriate training and education of dedicated auditors; participate and/or conduct external audit (affiliates and partners) of Galderma PV stakeholders, when required
- Perform or supervise PV supplier and subcontractor qualifications and periodically evaluate their quality level with regards to Galderma PV requirements and applicable regulation
- Coordinate the qualification of external PV partners
- Ensure the inspection readiness of the PV quality system (Corporate, Affiliates and direct partners), accompany these inspections and ensure appropriate follow-up
• Additional tasks
- Inform the EUQPPV, Corporate Compliance, Safety Officers and, when applicable, Affiliates General Managers about any issue that could affect or possibly affect the quality and integrity of the PV system
- Establish an efficient collaborative platform with the Corporate Compliance unit and other Quality groups (e.g. Quality Systems, Innovation Quality Departments) ensuring the control and on-going improvement of Galderma PV system
- Foster a PV quality culture in Corporate and Affiliates organizations
- Define Qualification and Validation programs for PV installations, equipment and systems (IES)
- Support appropriate contacts and relationships related to PV aspects with Competent Authorities worldwide
- Contribute to the elaboration and appropriate follow-up of cost center’s budget
- Lead, manage and develop the PV Quality Assurance Unit by managing the PV QA team (appropriate goals and objectives, develop expertise and skills, in respect of Company values and code of conduct)
Your profile:
•Pharmacist, MD, Scientific PhD, Engineer or equivalent degree
•Specialized education in Pharmacovigilance and/or Quality Management / Assurance
•Minimum 10 years within the Pharmaceutical industry, from which a significant part in Pharmacovigilance and/or Quality Management function
•Experience in working in an international matrix environment
•Ability to manage international projects complying with quality norms.