Senior Auditor, Quality Assurance

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
• Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership role.
• In-depth knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
• Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues.
• Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

What You Will Be Doing

• Serving as the Quality Assurance releasing authority for GMP/CMC activities, including review and disposition of applicable GMP documentation and activities prior to release.
• Providing dedicated Quality Assurance oversight for GMP operations, including manufacturing, pharmacy, QC laboratory, and other CMC-related activities, as applicable.
• Reviewing and approving GMP records and quality documentation, including batch records, deviations, investigations, CAPAs, change controls, and other applicable GMP documentation.
• Ensuring GMP/CMC activities are performed in accordance with applicable GMP requirements, internal quality systems, approved procedures, and client requirements.
• Providing independent QA guidance and decision-making support for GMP quality and compliance matters, including escalation and resolution of issues that may affect product quality or release.
• Partnering closely with Manufacturing, Pharmacy Services, QC Lab, and CMC teams to provide proactive QA oversight throughout planning and execution, rather than relying solely on retrospective review.
• Supporting inspection and audit readiness for GMP/CMC operations and driving continuous improvement of the site quality system.
• Acting as a key Quality representative for GMP/CMC operations and sponsor interactions related to quality, compliance, and release activities.
• Collaborating with cross-functional teams to identify areas for improvement in quality assurance processes and practices.
• Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
• Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements.
• Contributing to the continuous improvement of quality assurance programs and initiatives.