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Vice President, Quality Assurance - Olema Oncology
Software Engineer
Seeking a Vice President of Quality Assurance for a clinical-stage biopharmaceutical company focused on breast cancer. This role requires expertise in quality systems and regulatory compliance within the pharmaceutical industry.
About the role
Key Responsibilities
- Develop and implement comprehensive quality assurance strategies for clinical-stage biopharmaceutical operations.
- Ensure adherence to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines.
- Oversee the establishment and maintenance of robust quality management systems.
- Lead regulatory compliance efforts and prepare for inspections.
- Drive a culture of quality and continuous improvement across the organization.
- Manage and mentor the quality assurance team.
Requirements
- Extensive experience in Quality Assurance within the biopharmaceutical industry.
- Proven track record in managing quality systems for clinical trials.
- Deep understanding of GCP, GMP, and relevant regulatory requirements.
- Strong leadership and team management skills.
- Bachelor's or advanced degree in a relevant scientific field.