Global Quality Operation Manager - Distribution Oversight

About Us

We are a pioneering, family-owned pharmaceutical company dedicated to advancing the development and global commercialization of reproductive hormone therapies that support the lifelong health and well-being of both men and women. To complement our core offerings, we also provide high-quality food supplements and medical devices.

Our products are widely used in gynaecology, fertility, obstetrics, and endocrinology. With a presence in over 90 countries through a strong network of subsidiaries and distributors, we continue to grow sustainably. Today, we operate with approximately 1,500 employees, 22 subsidiaries, and 5 manufacturing sites. Our continued success is built on attracting exceptional talent and fostering a collaborative, growth-focused environment.

Position:

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.

Key Responsabilities :

Distribution oversight

• Leads the Technical Quality Agreement preparation and execution process.
• Monitor and assess the distribution process to guarantee that they meet quality standards and regulatory requirements.
• Monitor fulfilment of Quality Agreements with all entities responsible for storage, transportation and distribution (customers).
• In case of major or critical deviations in SC, supports investigation and quick resolution using QMS tools.
• Review and follow up of the change controls related to the distribution activities and support introduction of new customer in BH E2E SC.
• Execute annual evaluation of distributors (3PLs and customers) in line with applicable KPIs previously communicated (as per model of relationship)
• Participate in improvement initiatives.

Finished products oversight in E2E SC

• Oversee activities post release of product, ensuring that all necessary documents are accurate, complete and in compliance with Good Distribution Practice.
• Act as Distribution Oversight for all non-conformances and Quality system records. Lead Investigations of quality issues, deviation and complaints implementing corrective and preventive actions (CAPA) as needed.
• Ensure timely and effective resolution of quality issues, implementing CAPA and consequently monitor action effectiveness.

GDP Compliance oversight

• Develop Corporate Policies/SOPs of Besins Healthcare in compliance with GDP requirements
• Support the compliance of the 3PLs distribution activities with the GDP
• Evaluate transportation activities and establish plan for continual oversight of provided services
• Collaborate closely with SC in qualification of transportation routes and other qualification requirements addressed by BH partners.

Risk Management

• Identify potential risk in the distribution process and develop strategy to mitigate this risk.
• Escalate major and critical risks to the senior management .

Job Requirements:

• 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.