Quality Management Specialist
vor 24 Stunden
(Sr) Director of Quality Scienta –
Scienta are pleased to be partnering with a leading CDMO in the search for their new (Sr) Director of Quality.
Your Role
- Creation, review and maintenance of training plans for the Quality Systems and Compliance Team
- Responsible for main QMS processes at the site, including document management, change control, qualification and validation, IT validation, GxP training, deviation investigations and CAPA process
- Applying relevant quality management procedures and regulations, incorporating requirements into local processes to ensure compliance with internal and regulatory standards
- Work closely with Global Quality to ensure proper flow of information to and from the site
- Responsibility for functioning communication and escalation process on product quality in accordance with requirements and coordination of on-site investigations
- Observation and interpretation of quality KPIs at the site, proposing improvement measures
- Conducting customer audits and regulatory inspections, including preparation, participation and follow-up, as well as responsibility for and conduct of self-inspections
- Responsibility for and implementation of PQR management, CPV process and other trend activities
- Oversee the Quality department, strategy, budget and hires (approximately 90 FTE)
- 5+ years experience in large team management (10 direct reports and up)
- Relevant scientific education/degree
- 10+ years GMP experience
- Experience in a dynamic, fast-paced environment with client-facing interactions
- German and English required
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