Join our client as Quality Director and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.
Proclinical is recruiting for a Quality Director to ensure excellence in GxP compliance across validation and qualification activities. In this role, you will support new product introductions, facilitate smooth product transfers, and drive quality through effective change management and QbD-led lifecycle oversight.
Responsibilities:
- Oversee activities to ensure compliance with GMP and other regulatory guidelines.
- Develop and implement a validation maintenance program to periodically review validated systems.
- Oversee quality aspects of technology transfer activities, maintaining alignment with applicable regulations.
- Review and approve validation protocols for facilities, utilities, equipment, software, and laboratory systems.
- Lead validation efforts for computer systems and data integrity requirements.
- Manage the cleaning validation program, including master plans and ongoing maintenance.
- Assess and approve change control activities related to validation and qualification.
- Ensure laboratory business applications and automation meet testing and production needs during system changes.
- Support Pre-Approval Inspections (PAI) and routine regulatory inspections as a topic lead or host.
Key Skills and Requirements:
- Degree in Chemistry, Biology, Engineering, or a related discipline.
- Experience in the pharmaceutical industry, particularly in process lifecycle management and quality operations.
- Familiarity with cGMP regulations, process validation, and product characterization guidelines.
- Proficiency in analytical equipment use, method validation, and analytical validation/transfer.
- Strong leadership skills, including team management, coaching, and workflow coordination.
- Effective communication, presentation, and report-writing abilities.
- Problem-solving and troubleshooting expertise with a collaborative and innovative mindset.
- Knowledge of site business drivers and ability to influence and support cross-functional teams.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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