Head of Clinical Operations

vor 11 Stunden

Dresden, Deutschland BioTalent Vollzeit

**Head of Clinical Operations**

BioTalent is partnered with a leader provider of integrated pharmaceutical development services to find a Head of Clinical Operations to join them on a permanent basis at their site in Brandenburg, Germany.

Alongside being responsible for the training and development of site staff, the successful incumbent will also be tasked with the management and coordination of all logistics, warehousing,

clinical supply packaging and labelling activities within the GMP facility.

This position requires fluency in both German & English and can facilitate working from home 1 - 2 days per week.

**Responsibilities**:

- 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 of the Berlin Clinical Operations.
- 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 cGMP, and GCP policies, procedures and rules.
- Manages direct reports including Head of Production and Team Leader Logistics.

**Key Experience Needed**:

- Direct line management experience
- Background in clinical operations
- Strong understanding of GMP standards & regulations
- Supply chain background would be desirable - logistics, warehousing etc.
- Demonstrable experience in training and developing staff

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