Head of Clinical Operations

Overview:

Our client is  seeking an experienced and motivated professional to lead and manage clinical supply chain operations, including logistics, warehousing, packaging, and labelling activities. This role ensures compliance with Good Manufacturing Practices (GMP), standard operating procedures (SOPs), client-specific requirements, and regulatory standards while fostering a skilled and efficient team. The position also focuses on optimizing processes and ensuring operational excellence within a dynamic and regulated environment.

Key Responsibilities:

• Oversee and supervise clinical operations, including shipping requests, returns/destruction processes, and support for packaging activities.
• Ensure compliance with all relevant regulations, including AMG, and verify that finished product batches meet client and GMP standards.
• Develop and implement systems and procedures to enhance the efficiency and quality of packaging and labelling operations.
• Act as the registered Head of Production with the local regulatory authority for clinical operations.
• Ensure retention of reserve samples for medicinal products, investigational medicinal products, and starting materials in line with regulatory requirements.
• Collaborate with the Project Management team to plan and execute packaging timelines, ensuring a cross-functional approach to meet internal and external expectations.
• Monitor and report on operational metrics and key performance indicators (KPIs) for logistics and packaging departments.
• Train, mentor, and develop team members to build a skilled, versatile, and motivated workforce.
• Manage the preparation and organization of packaging documentation, ensuring accuracy and compliance with GMP, SOPs, and client requirements.
• Ensure deviations and production changes are reviewed, approved, and communicated to clients as necessary.
• Manage direct reports, including the Warehouse Manager and Clinical Planning Manager.

Qualifications and Experience:

• Degree in business, science, or a related field, or equivalent qualifications.
• Significant experience in a similar role with a proven track record of success.
• In-depth knowledge of GMP and GDP regulations.
• Experience with ERP systems, ideally JDE (Oracle).
• Fluency in English and German.
• Demonstrated leadership skills and the ability to foster team collaboration.
• Analytical mindset with strong attention to detail and technical aptitude.

Skills:

• Excellent interpersonal and communication skills.
• Proven ability to lead and motivate teams.
• Strong problem-solving skills and an analytical approach to challenges.
• Proficiency in managing complex regulatory and operational requirements.