Head of Clinical Operations

vor 3 Wochen


Großbeeren, Brandenburg, Deutschland PCI Pharma Services Vollzeit
Job Title: Head of Clinical Operations

PCI Pharma Services is seeking an experienced Head of Clinical Operations to join our team. As a key member of our operations team, you will be responsible for the management and coordination of all logistics, warehousing, clinical supply packaging and labelling activities within our facility.

Key Responsibilities:
  • Manage and supervise the Clinical Operations department to ensure timely and accurate execution of shipping requests, returns and destruction processes, and support for clinical packaging facility.
  • Ensure compliance with Good Manufacturing Practices (GMP), standard operating procedures (SOPs), client-specific requirements, and applicable government regulations.
  • Develop and implement systems and procedures to ensure high quality and efficient packaging and labelling operations of clinical supplies.
  • Lead the development and implementation of processes to ensure retention of reserve samples of finished medicinal products, clinical investigational medicinal products, and starting materials in accordance with §18 AMWHV.
  • Work closely with the Project Management team to provide input into the planning and execution of packaging timelines and achieve internal and external customer expectations with all departments.
Requirements:
  • Bachelor's degree or equivalent qualification in a relevant field.
  • 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 and leadership skills.
  • Business fluency in English and German.
  • High flexibility and ability to adapt to a fast-paced environment.

PCI Pharma Services is a leading global contract development and manufacturing organization (CDMO) providing integrated services to the pharmaceutical and biotechnology industries. We are committed to delivering high-quality products and services that meet the needs of our customers and patients.



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