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.
