Quality Management Director
vor 4 Wochen
Job Title: Director, Quality Management
Job Summary:
We are seeking a highly experienced and skilled Director of Quality Management to join our team at PSI. The successful candidate will be responsible for leading our quality management efforts, ensuring compliance with regulatory requirements, and driving continuous improvement in our quality systems.
Key Responsibilities:
- Develop and implement quality management strategies to ensure compliance with regulatory requirements and industry standards.
- Lead quality assurance audits, including planning, conducting, and reporting.
- Manage and oversee the preparation and maintenance of quality assurance documentation.
- Collaborate with cross-functional teams to identify and implement process improvements.
- Develop and maintain relationships with regulatory agencies and industry partners.
- Provide training and guidance to staff on quality management principles and practices.
- Stay up-to-date with industry developments and regulatory changes, and ensure PSI's quality systems are aligned with best practices.
Requirements:
- Minimum 7 years of experience in clinical research, with a minimum of 5 years in a quality assurance or regulatory compliance role.
- Proven track record of leading quality management initiatives and driving compliance with regulatory requirements.
- Excellent knowledge of ICH GCP guidelines, FDA/EMA regulations, and applicable local regulations.
- Strong leadership and communication skills, with the ability to work effectively with cross-functional teams.
- Intermediate proficiency in MS Office (Word, Excel, PowerPoint, Outlook).
What We Offer:
PSI offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced quality management professional looking for a new challenge, please submit your application.
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