Quality Management Director
vor 2 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
- Lead quality assurance audits and investigations, and implement corrective actions as necessary
- Collaborate with cross-functional teams to identify and mitigate quality risks
- Develop and maintain quality systems documentation, including policies, procedures, and training materials
- Provide training and coaching to quality staff on quality management principles and regulatory requirements
- Stay up-to-date with regulatory requirements and industry best practices, and implement changes as necessary
Requirements:
- Minimum 7 years of experience in clinical research, with a minimum of 5 years in a quality assurance or regulatory compliance role
- Strong knowledge of ICH GCP guidelines, FDA/EMA regulations, and applicable local regulations
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams
- Strong analytical and problem-solving skills, with the ability to identify and mitigate quality risks
- Intermediate proficiency in MS Office, with the ability to create and maintain quality systems documentation
What We Offer:
PSI offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are an equal opportunities employer and welcome applications from diverse candidates.
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