Planet Pharma
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The Sr. Manager, Research and Development (R&D) Quality Assurance will independently perform the duties of the QA Program Lead (PL) role, providing Clinical Quality Assurance oversight of assigned clinical studies, ensuring the conduct and compliance of clinical trials in alignment with the Protocol, International and Local Regulations. The Snr. Manager will lead inspection readiness for assigned studies and support audit activities as required.
Key Responsibilities include:
- Executing the R&D Program Lead (PL) role, overseeing compliance with protocols, SOPs, GCP, and regulations.
- Leading development and execution of audit plans, supporting ISA activities, and developing audit reports and CAPAs.
- Leading quality activities for Phase 2 & 3 trials, including risk management.
- Overseeing inspection readiness efforts and supporting regulatory inspections.
- Managing inspection-related CAPAs and quality events.
- Supporting vendor oversight and process audits.
- Maintaining knowledge of GxP requirements and industry developments.
Qualifications include:
- Bachelors degree in life sciences or related field; Masters preferred.
- At least 7 years in GCP QA or related experience in clinical trials.
- Experience in leading audits and inspection readiness.
- Knowledge of GCP regulations and industry guidance.
Pay ranges between $85-93/hr based on experience.
Note: The job posting appears to be active and not expired.
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