Key Responsibilities
- Quality Management System (QMS): Develop, implement, and maintain the QMS to ensure compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and other relevant regulations.
- Audits and Inspections: Plan and conduct internal audits and prepare for external inspections by regulatory agencies. Ensure timely resolution of any findings.
- Training and Development: Design and deliver training programs for staff on quality assurance processes, regulatory requirements, and best practices.
- Documentation Control: Oversee the management of quality-related documentation, including standard operating procedures (SOPs), work instructions, and quality records.
- Risk Management: Identify potential quality risks and develop mitigation strategies to ensure compliance and operational excellence.
- Collaboration: Work closely with cross-functional teams, including clinical operations, regulatory affairs, and project management, to ensure quality is integrated into all aspects of our work.
Qualifications
- Bachelor’s degree in Life Sciences, Quality Assurance, or a related field. A Master’s degree is a plus.
- Minimum of 5 years of experience in quality assurance within a CRO or pharmaceutical environment.
- Strong knowledge of GCP, GLP, and other relevant regulatory guidelines.
- Proven experience in conducting audits and inspections.
- Excellent communication and interpersonal skills, with the ability to work collaboratively in a team-oriented environment.
- Strong analytical and problem-solving skills, with a keen attention to detail.
- Proficiency in quality management software and tools.
Interested candidates should submit their resume and a cover letter to Anna Bashmakova at anna.bashmakova@palleos.com
