Quality Operation - Distribution Oversight

Besins Healthcare; Paris; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A global pharmaceutical company is seeking a Quality Operation Manager in Paris to oversee quality compliance in GDP operations. Responsibilities include managing Technical Quality Agreements, ensuring compliance with regulatory standards, and driving resolution of quality issues. Candidates should have at least 5 years of experience in the pharmaceutical industry, a university degree in a relevant field, and fluent English skills. This role offers the opportunity to work in an international environment.

Qualifications

• Minimum of 5 years experience in the pharmaceutical industry, primarily in 3PL management.
• Sound knowledge of relevant EU & US regulations, EMA, FDA, ICH and other guidelines.
• Ability to work in an international matrix environment.

Responsabilités

• Lead the preparation and management of Technical Quality Agreements.
• Ensure compliance with quality standards and regulatory requirements.
• Drive timely resolution of quality issues and monitor CAPA effectiveness.

Connaissances

Pharmaceutical industry experience

Knowledge of EU & US regulations

Proficient in Microsoft office

Strong communication skills

Fluent English

Formation

University degree in science, engineering, or pharmaceutical field

Master’s degree

Outils

ERP tools

Description du poste

About Us

Besins Healthcare, founded in 1885, is a global, family-owned pharmaceutical company specializing in medical-grade hormones. With expertise in gynaecology, fertility, obstetrics, endocrinology, and hormone deficiency treatments, we are dedicated to advancing reproductive hormone therapies that support lifelong health and well-being.

Our multicultural team of more than 1,500 employees, across 22 affiliates and 5 production sites, supports our presence in over 90 countries. Together, we continue to grow through innovation, expanding our products into new territories, and building strong partnerships worldwide.

Purpose of the job

The Quality Operation Manager will be in charge of the quality oversight of the topics related to GDP operations : from API / bulk product supply, and finished product distribution to the customers. He / she will support and monitor service providers as 3PL and transportation services, and distributors on end markets.

This is a corporate cross functional role that will cover working in the global organisation.

Distribution Oversight

• Lead the preparation, execution, and ongoing management of Technical Quality Agreements.
• Monitor and evaluate distribution processes to ensure compliance with quality standards and regulatory requirements.
• Ensure fulfilment of Quality Agreements with all entities involved in storage, transportation, and distribution (including customers).
• Support investigations and timely resolution of major or critical supply chain deviations using QMS tools.
• Review, approve, and follow up on change controls related to distribution activities; support onboarding of new customers in the BH E2E supply chain.
• Conduct annual distributor evaluations (3PLs and customers) against predefined KPIs, aligned with relationship models.
• Contribute to and actively participate in process improvement initiatives.

Finished Product Oversight in E2E Supply Chain

• Oversee all post-release product activities, ensuring documentation accuracy, completeness, and compliance with Good Distribution Practices (GDP).
• Serve as Distribution Oversight for non-conformances and quality system records; lead investigations into quality issues, deviations, and complaints, implementing CAPA where required.
• Drive timely and effective resolution of quality issues and monitor CAPA effectiveness.

GDP Compliance Oversight

• Develop and maintain Besins Healthcare corporate policies and SOPs in alignment with GDP requirements.
• Support and monitor GDP compliance of 3PL distribution activities.
• Evaluate transportation operations and implement continuous oversight plans for service quality.
• Partner with Supply Chain to qualify transportation routes and address other qualification requirements in collaboration with BH partners.

Risk Management

• Identify risks within distribution processes and define mitigation strategies.
• Escalate major and critical risks to senior management in a timely manner.

Expected competencies

• University degree in science, engineering or pharmaceutical related field.
• Master’s degree is an added value.
• At least 5 years ‘experience in the pharmaceutical industry, primarily in the 3PL management field.
• Sound knowledge of the relevant EU & US regulation, EMA, FDA, ICH and other guidelines and regulatory standards.
• Proficient in Microsoft office. Experience in ERP tools.
• Strong communication skills.
• Ability to work in an international matrix environment.
• Fluent English skills required, French or other languages will be a plus.

Interested? Please apply and join us!