Senior Manager, Quality Validation

Senior Manager, Quality Validation Overview: Join a dynamic team as a Senior Manager, Quality Validation, where your expertise will be pivotal in ensuring the integrity and compliance of critical validation activities within a fast-paced pharmaceutical environment. This role offers the opportunity to lead Quality Assurance oversight across transport and packaging validation processes, supporting our journey towards commercial readiness. If you thrive in a collaborative setting and have a passion for maintaining the highest standards of quality in GMP manufacturing, this position is your next career milestone. Required Skills: Bachelor’s degree in a scientific or technical discipline At least 8 years of experience in the pharmaceutical industry Proven experience providing QA oversight of transport validation and packaging process validation Strong knowledge of GMP manufacturing, process validation (PPQ), and quality systems Demonstrated ability to manage validation, packaging, and testing activities at CMOs Familiarity with US and global compliance regulations and industry best practices Proficiency with Microsoft Office suite and other relevant systems Excellent troubleshooting, critical thinking, and problem-solving skills Strong collaboration and management abilities Ability to handle multiple priorities within aggressive timelines Nice to Have Skills: Additional experience supporting process validation (PPQ) and commercial readiness Experience in inspection readiness, both domestically and internationally Previous roles involving CMO oversight and oversight of GMP documentation and systems Knowledge of quality metrics development and reporting Familiarity with industry-standard validation and quality SOPs Preferred Education and Experience: Bachelor’s degree (preferably in a scientific or technical field) 8+ years of pharmaceutical or biotechnology industry experience with a focus on validation and quality oversight Other Requirements: Location: Hybrid position based in Redwood City, CA Travel: Occasional travel may be required for inspections or oversight Certification or additional training in GMP, validation, or regulatory compliance is a plus This role supports a W2 employment model Elevate your career by leading critical validation initiatives in a company committed to excellence and innovation. Your expertise will ensure seamless quality systems and support successful product launches in a regulated environment. #J-18808-Ljbffr DeWinter Group