Requirements: English
Company: SUN PHARMA
Region: Hoofddorp , North Holland
About the Role
We are seeking an experienced professional with a strong background in clinical trials and investigational medicinal products (IMP) within a pharmaceutical or biotech environment. This role will be key in ensuring compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and regulatory requirements for IMP management throughout the clinical trial lifecycle.
Key Responsibilities
- Oversee IMP-related activities, ensuring compliance with regulatory requirements, GCP, and GMP guidelines.
- Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance, to ensure seamless IMP supply and management.
- Support the planning, coordination, and oversight of IMP manufacturing, packaging, labeling, distribution, and storage for clinical trials.
- Ensure that IMP handling processes align with clinical trial protocols and regulatory standards.
- Assist in vendor qualification, including CMOs, CROs, and clinical sites, to ensure adherence to quality and compliance expectations.
- Monitor deviations, change controls, and corrective/preventive actions (CAPAs) related to IMPs.
- Support clinical trial submissions and regulatory interactions as needed.
- Provide training and guidance on IMP-related processes to internal and external stakeholders.
Required Qualifications & Experience
- Bachelors/Masters degree in Pharmacy, Life Sciences, or a related field.
- Extensive experience in clinical trials within the pharmaceutical or biotech industry.
- Strong knowledge of GCP, GMP, and regulatory requirements for IMPs (e.g., EMA, FDA, MHRA).
- Experience in IMP supply chain management, including manufacturing, packaging, and distribution.
- Ability to work cross-functionally and communicate effectively with internal and external stakeholders.
- Strong problem-solving skills and a proactive approach to quality and compliance challenges.
Preferred Qualifications
- Experience working with CMOs, CROs, or clinical trial sponsors.
- Familiarity with Qualified Person (QP) oversight and responsibilities is a plus but not required.
- Understanding of regulatory submission processes related to IMPs.
What We Offer
- A dynamic and collaborative work environment within a global pharmaceutical company.
- Opportunities for professional growth and development in clinical trial operations and IMP management.
- Competitive salary and benefits package.