Clinical Quality Manager

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Recruitment Officer at Besins Healthcare

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.

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.

Purpose of the job:

The position will be responsible to ensure compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols. This position will collaborate with other global functions such as Clinical Operations, Medical, Regulatory, Project Management, Pharmacovigilance etc.

Key Responsabilities :

• Establish appropriate system for clinical quality management and oversight a of investigational sites and vendors.
• Collaborate with stakeholders in the cross functional departments (Clinical Operations, Project Management Office, Medical, Regulatory, PV etc.) to support clinical trial programs for the organisation for both new compounds and new indications for marketed products.
• Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted globally and locally, where required
• support in writing clinical documented process in applicable SOPs and support continuous process improvements;
• Ensure processes compliance to applicable Standard Operating Procedures (SOPs) and regulations;
• Manage inspection readiness and coordinate its activities;
• Qualify CRO and other vendors related to the clinical activities;
• Create risk-based study-specific audit plans, schedule, and conduct investigator site audits per the study audit plan to ensure study conduct at the audited site complies with applicable Regulations and Good Clinical Practice standards;
• Ensure CRO/investigator monitoring programs are in place to ensure compliance with protocol, GCP and applicable regulatory requirements and relevant internal policies and procedures for the studies
• Support in management of quality records e.g. change controls, investigations, deviations and CAPAs to closure;

Job Requirements:

• University degree (preferably Life Science);
• 5-8 years of experience in Clinical Quality oversight from Sponsor perspective (clinical QA experience in the pharmaceutical industry required);
• Demonstrated knowledge of ICH GCP, global regulations and guidelines applicable for the conduct of clinical trials;
• A complete understanding and application of principles, concepts and practices of clinical research procedures;
• Experience of developing audit and/or quality oversight processes in GxP areas;
• Experience of preparing for and hosting regulatory inspections;
• Ability to lead and support several concurrent projects and develop strong relationships within cross-functional teams;
• Strong communication skills both written and verbal;

Seniority level

• Seniority levelAssociate

Employment type

• Employment typeFull-time

Job function

• Job functionManufacturing
• IndustriesPharmaceutical Manufacturing

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