Head of Clinical Operations Permanent

Head of Clinical Operations

Department: Clinical Operations   

Reporting To: Site Lead Berlin Clinical Operations

Special Competences:

• Role as the Head of Manufacturing in accordance with German Drug Law 
• Management of the Clinical Manufacturing and Warehouse areas at the site, in line with corporate strategy and within regulatory requirements

JOB OBJECTIVE:

• The Head of Clinical Operations is responsible for the management and coordination of all logistics, warehousing, clinical supply packaging and labelling activities within the facility, ensuring compliance with Good Manufacturing Practices (GMP), standard operating procedures (SOPs), client-specific requirements, and applicable government regulations.
• In addition, the Head of Clinical Operations is responsible for training and development of staff to create a motivated, versatile, and trained Operations team, enabling process efficiencies, deputy roles and requirements.

TASKS:

• Manages & supervises the Clinical Operations department responsible for (a) executing shipping requests in a timely and accurate manner (b) returns/destruction process (c) supporting the needs of clinical packaging facility.
• Good understanding and work in compliance with AMG.
• Ensures and verifies that finished product batches are produced in accordance with client requirements and with Good Manufacturing Practices.
• Leads the development and implementation of systems and procedures to ensure high quality and efficient packaging and labelling operations of clinical supplies.
• Registered with the local regulatory authority as the Head of Production.
• Ensures retention of reserve samples of finished medicinal products, clinical investigational medicinal products and starting materials in accordance with §18 AMWHV.
• Works closely with the Project Management team to provide input into the planning and execution of packaging timelines. Cross functional approach to achieve internal and external customer expectations with all departments.
• Represents the logistics management and packaging department during all regulatory and safety audits, as required.
• Attends client and internal project meetings as required.
• Captures and reports on packaging operations metrics and logistics department KPIs.
• Recommends and implements changes where necessary to improve efficiencies, reduce costs while maintaining or improving clients’ experience.
• Develops, trains and mentors direct reports to maximize their performance and professional advancement.
• Manages the preparation and organization of all packaging documentation in a timely manner, ensuring that it is of the highest quality and compliant with GMPs, SOPs and client-specific requirements, to ensure a smooth and accurate packaging operation.
• Ensures and verifies that all deviations and any planned change in production and quality control have been reviewed and approved by the responsible people. Ensures that client is informed of deviations and changes and that client approval is obtained if necessary.
• Responsible for continuous optimization of processes.
• Ensures required production and quality control documentation is complete and signed off by responsible personnel. Communicates packaging project status to management and co-workers, identifying problems in a timely manner with suggested solutions.
• Knowledge of and adherence to all policies, procedures and rules.
• Manages direct reports including Head of Production and Team Leader Logistics.
• Where required, undertakes tasks and projects outside the job holder’s area of responsibility, such as expansion or new processes or equipment.

REQUIREMENTS:

• Business or science degree or equivalent qualification.
• Several years of experience in a similar role with demonstrable experience
• Knowledge of GMP and GDP regulations.
• Experience in operating ERP systems, ideally JDE (Oracle)
• Excellent interpersonal skills
• Excellent team player with leadership skills
• Strong written and verbal communication skills in English and German
• High flexibility or the ability to adapt, react quickly and deal with change in a fast-paced environment
• Technical aptitude
• Analytical approach with attention to detail