Head of Operations (m/w/d)
Apply locations: Grossbeeren, GER | Full time | Posted 4 Days Ago | Job Requisition ID: JR114214
About PCI:
Life-changing therapies. Global impact. Connecting biopharma companies with patients worldwide.
We are PCI. Our investment is in people who make an impact, drive progress, and create a better tomorrow. We build teams globally to pioneer and shape the future of PCI.
Department & Supervisor:
Clinical Operations | Supervisor Job Title: Site Lead Berlin Clinical Operations
Location:
Großbeeren / Berlin
Key Responsibilities:
* Lead manufacturing activities in accordance with German Drug Law (AMG), overseeing clinical manufacturing and warehouse operations aligned with corporate and regulatory standards.
* Manage logistics, warehousing, packaging, and labeling of clinical products, ensuring compliance with GMP, SOPs, and legal requirements.
* Hire, train, develop, and motivate staff to maintain a skilled and efficient team.
* Ensure production of finished products meets client specifications and GMP standards.
* Develop and implement systems for high-quality packaging and labeling processes.
* Register as the Head of Production with local authorities.
* Manage retention of samples per §18 AMWHV.
* Collaborate closely with project management for planning and execution of packaging timelines.
* Represent logistics and packaging during audits and client meetings.
* Monitor and report KPIs and operational metrics.
* Implement process improvements to increase efficiency and reduce costs.
* Oversee documentation, deviations, and change management, ensuring client communication and approvals.
* Optimize processes continuously and ensure documentation compliance.
* Manage direct reports including the Head of Production and Logistics Manager.
* Participate in tasks outside core responsibilities when necessary, such as process expansion or equipment upgrades.
Qualifications & Requirements:
Proven leadership in clinical manufacturing and logistics, knowledge of GMP, GMP compliance, and German drug law (AMG). Strong organizational, communication, and team development skills.
Equal Opportunity Statement:
PCI Pharma Services is an Equal Opportunity Employer committed to diversity and inclusion. We do not discriminate based on race, color, religion, gender, or other protected statuses.
About Us:
At PCI, we focus on quality, operational excellence, and delivering an exceptional customer experience. We foster a culture of learning, growth, and purpose, aiming to be a fulfilling place for talented individuals to develop their careers.
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