R&D Corrective Actions Program Lead
2 weeks ago
About Gilead Sciences International, Ltd.
Gilead Sciences International, Ltd. is a leading biopharmaceutical company dedicated to developing innovative therapies for serious diseases. Our mission is to advance healthcare worldwide through groundbreaking research and the delivery of life-changing treatments.
About R&D Quality at Gilead
Our R&D Quality team plays a vital role in ensuring the safety, efficacy, and quality of our pharmaceutical products. We are a collaborative and dedicated group of professionals committed to upholding the highest standards in research and development.
Job Description: R&D Corrective Actions Program Lead
We are seeking a highly motivated and experienced professional to lead our R&D Corrective Actions program. This individual will be responsible for developing, implementing, and maintaining a robust system for identifying, investigating, and resolving deviations and nonconformities within our research and development processes.
Key Responsibilities:
- Develop and implement policies, procedures, and guidelines for the R&D Corrective Actions program.
- Lead investigations into deviations and nonconformities, identifying root causes and recommending corrective actions.
- Collaborate with cross-functional teams to ensure timely and effective implementation of corrective actions.
- Track and monitor the effectiveness of implemented corrective actions.
- Conduct audits and assessments to ensure compliance with regulatory requirements and internal standards.
- Stay abreast of industry best practices and regulatory guidelines related to corrective actions.
Qualifications:
- Bachelor's degree in a scientific or engineering discipline.
- Minimum 5 years of experience in a quality assurance role within the pharmaceutical or biotechnology industry.
- Strong understanding of Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work independently and as part of a team.
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