Regional Director QA Affiliates Northern & Southern Europe - Pharmacien Responsable

Job Purpose

Are you a strategic Quality leader looking to make a meaningful impact on patient safety, regulatory excellence, and business performance across Europe?
We are seeking an experienced Head of Quality – Northern/Southern Europe to lead our regional Quality organization and drive excellence across multiple European affiliates. In this key leadership role, you will be responsible for ensuring compliance with GMP, GDP, corporate standards, and applicable regulatory requirements while safeguarding product quality, patient safety, and supply continuity.
As the designated Pharmacien Responsable for France, you will provide pharmaceutical oversight of the French affiliate and ensure compliance with French and European pharmaceutical regulations. You will serve as a trusted partner to senior leadership, regulatory authorities, and cross-functional stakeholders, driving a strong culture of quality, compliance, continuous improvement, and risk-based decision-making across the region. The eligibility to act as Pharmacien Responsable in France is mandatory for this position.
This is an exciting opportunity to combine strategic regional leadership with a critical statutory role, influencing quality performance, regulatory compliance, and organizational success in a dynamic international environment.

Key Responsibilities

- Lead the regional Quality strategy, ensuring alignment with global objectives while supporting patient safety, supply continuity, and business growth.
- Drive GMP/GDP compliance and inspection readiness across multiple European affiliates, ensuring adherence to corporate standards and regulatory requirements.
- Strengthen and harmonize Quality Systems and processes across the region, fostering operational excellence and continuous improvement.
- Lead, coach, and develop Quality teams, building a high-performing organization and promoting a strong culture of quality, integrity, and accountability.
- Provide oversight of Quality operations, including deviations, CAPAs, complaints, change controls, risk management, and product quality activities.
- Support strategic business initiatives, including product launches, acquisitions, business development projects, and supply continuity programs.
- Ensure effective Quality oversight of external partners, including contract manufacturers, distributors, licensors, and other key service providers.
- Act as the designated Pharmacien Responsable (Qualified Person) for France, ensuring compliance with French and European pharmaceutical regulations and overseeing pharmaceutical activities impacting patient safety.
- Ensure EU batch certification and release activities in accordance with applicable European regulations.
- Provide pharmaceutical oversight of product quality, distribution, pharmacovigilance governance, product information and recall activities impacting patient safety and regulatory compliance.
- Represent the company in front of Health Authorities, including ANSM, during inspections and regulatory interactions.
- Serve as a trusted advisor to senior leadership, providing guidance on quality, compliance, patient safety, and business continuity risks while driving appropriate mitigation strategies.

Required Education

- Doctor of Pharmacy (PharmD)

- Eligibility to act as Pharmacien Responsable in France, including registration with the relevant section of the French Order of Pharmacists.

Required Skills and Experience

- Minimum 10-12 years of experience in the pharmaceutical industry, including at least 5 years in a Quality leadership role.

- Extensive experience operating in global Quality environments within highly regulated industries, driving alignment and collaboration across international markets and functions.Experience managing third-party manufacturers, distributors, licensors, and strategic partners.

- Demonstrated ability to lead, develop, and coach teams while influencing senior stakeholders in a matrix organization.

- Experience supporting regulatory inspections and managing complex compliance situations.

- Strong communication, leadership, organizational, stakeholder management, and change management skills.

- Ability to balance strategic regional leadership responsibilities with statutory pharmaceutical obligations.

Technical Competencies

- Strong expertise in EU GMP/GDP requirements and pharmaceutical regulations.

- Solid knowledge of French pharmaceutical legislation, including Pharmacien Responsable responsibilities and ANSM requirements.

- Proven experience in Quality Management Systems (QMS), including deviations, CAPAs, change controls, complaints, and risk management.

- Expertise in regulatory inspections, audits, and inspection readiness.

- Strong understanding of pharmacovigilance, product quality oversight, recalls, and patient safety requirements.

- Experience driving Quality harmonization, standardization, and continuous improvement across multiple countries.

- Proven ability to manage and oversee third-party manufacturers, distributors, and strategic partners.

- Experience supporting product launches, acquisitions, and supply continuity initiatives from a Quality perspective.

- Strong capability to assess and mitigate quality, compliance, and business continuity risks.

- Demonstrated success interacting with Health Authorities and influencing stakeholders in an international environment.

Required Behaviours and Competencies

- Strategic leadership with the ability to translate vision into action.

- Proven people leadership, coaching, and team development skills.

- Strong stakeholder management and influencing capabilities across matrix organizations.

- Sound decision-making and risk management in complex regulated environments.

- Excellent communication skills and executive presence.

- Change management and continuous improvement mindset.

- Strong analytical, problem-solving, and results-oriented approach.

- High level of integrity, accountability, and commitment to compliance.

- Collaborative leadership style with the ability to work effectively across functions and geographies.

- Resilient, adaptable, and able to thrive in a fast-paced international environment.

- Strong focus on quality, patient safety, and business outcomes.

Required Languages

- Fluency in English is required.

- French is mandatory due to the statutory Pharmacien Responsable responsibilities.

Travel required in %

20%