Offer summary

Qualifications:

Bachelor's Degree in a Science discipline preferred., 5+ years of experience in a Clinical Quality oversight role., Clinical QA experience in the pharmaceutical industry is essential., Strong project management and communication skills, both written and verbal..

Key responsabilities:

Develop and maintain a clinical quality management system for investigational sites and vendors.

Collaborate with cross-functional teams to support clinical trial programs.

Ensure compliance with GCP/ICH standards and monitor adherence to SOPs and regulatory requirements.

Conduct audits and oversee inspection readiness efforts to ensure quality in clinical operations.

Job description

For over a century and five generations, this family-owned company has been dedicated to improving lives through innovative healthcare solutions, particularly in hormonal treatments for women's and men's health.

Now seeking a Clinical Quality Manager (GCP), the company continues to build on its legacy of pioneering breakthroughs. Over the past 20 years, they have expanded into a global operation with a direct presence in 22 countries and a multicultural team of 1,500 employees worldwide - having doubled in size in recent years. Generating $500 million in annual revenues, their remarkable growth is driven by a commitment to innovation, diversity, and a deep understanding of what truly matters to patients and their families.

The Position

Develop and maintain an effective clinical quality management system to oversee investigational sites and vendors.
Collaborate with cross-functional teams (Clinical Operations, Project Management Office, Medical, Regulatory, Pharmacovigilance, etc.) to support clinical trial programs for both new products and new indications of marketed products.
Ensure GCP/ICH-compliant systems and processes are established and maintained to uphold the quality of clinical trials conducted globally and locally, as needed.
Contribute to the development, review, and continuous improvement of clinical processes and Standard Operating Procedures (SOPs).
Monitor adherence to applicable SOPs, guidelines, and regulatory requirements across clinical activities.
Oversee inspection readiness efforts, including planning and coordination of inspection-related activities.
Assess and qualify Clinical Research Organizations (CROs) and other vendors involved in clinical operations.
Develop audit plans, and conduct investigator site audits to ensure compliance with protocols, Good Clinical Practice (GCP), and applicable regulations.
Oversee CRO and investigator monitoring activities to ensure alignment with protocols, GCP, regulatory requirements, and internal policies.
Manage quality records, including change controls, investigations, deviations, and Corrective and Preventive Actions (CAPAs), ensuring timely resolution and closure.

The Person