Quality Director & Qualified Person

Olon Group is a global leader in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) for the CDMO and Generics markets. We integrate chemical synthesis and biological processes, consistently operating in compliance with the highest international standards of quality, safety, and environmental protection.

With an international footprint comprising 14 manufacturing sites and 14 R&D centers worldwide, we continue to grow and invest in our people.

For our manufacturing site in France, we are currently looking for a:

Quality Director & Qualified Person to join our team and help drive the future success of our Toulouse site (40 employees), a pharmaceutical manufacturing facility authorized for drug product manufacturing, with two production lines dedicated to API manufacturing and fill-and-finish operations.

The Quality Director & Qualified Person is playing a key role in supporting the success of our clients' projects by ensuring the highest standards of quality, compliance, and regulatory oversight for the APIs and fill-and-finish drug products.

Your Responsibilities

• Work closely with the Company’s CEO and the Quality Director of OLON Group, leading the site quality strategy, ensuring regulatory compliance and adherence to GMP standards across all activities (development, production, quality control, batch release)
• Serve as a Qualified Person (QP) / Chief Pharmaceutical officer, ensuring compliance with GMP and ANSM requirements in activities related to Development, Production, and Batch Control of biotechnological products for both clinical and commercial phases. As Qualified Person you’ll be responsible for maintaining the pharmaceutical establishment, and the batch certification and release of finished products.
• Supervise the Quality Assurance and the Quality Control teams.
• Act as primary point of contact for clients and health authorities on all quality-related matters. Together with your team, you’ll prepare, conduct, and successfully manage clients’ audits and inspections (ANSM, EMA, FDA, etc.) and manage non-conformities, deviations, complaints, OOS , self-inspections, suppliers audits and oversee CAPA plans.
• Contribute to the continuous improvement of the quality system, team development, and the site quality culture.

Profile

• Doctor of Pharmacy, registered with the Order (section B), authorized to act as Qualified Person / Chief Pharmaceutical officer.
• Proven experience (minimum 7 years) in pharmaceutical quality within a production site, ideally in a biotechnological CDMO environment.
• Strong knowledge of quality standards (GMP, ISO, FDA) and regulatory GMP and CMC requirements applicable to biological and sterile products.
• Demonstrated leadership, rigor, organizational skills, and ability to unite and lead multidisciplinary teams.
• Fluent professional English is mandatory.

What We Offer :

• Permanent contract (CDI), managerial status, annual working time arrangement of 218 days with compensatory leave (JRTT)
• Company health insurance, 1 day of teleworking per week, time savings account (CET), and meal vouchers
• A dynamic and innovative work environment open to creativity and personal contributions, with opportunities to participate in pioneering projects in a fast-evolving industry
• Access to training programs and internal mobility opportunities in line with Olon Group strategy
• An inclusive and supportive environment promoting diversity and integration for all

The compensation range for this position is defined in accordance with Olon’s Professional Model salary bands (Director, Manager, and Professional levels). This information will be shared transparently before the start of the selection process and will be discussed during the initial screening interview.

Olon is committed to providing equal employment opportunities. Our policy is to offer employment opportunities without discrimination based on age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, or any other characteristic protected by applicable local laws.