Position: Senior QA - Compliance & Inspection Management
Location: San Diego, CA
George Higginson is currently searching for an experienced Senior QA Specialist, with experience in both Compliance and Inspection Management, for a Biologics specialist CDMO.
The incumbent is responsible for supporting site management ensuring the site performs in a state of compliance by supporting all Quality Compliance and Inspection Management oversight activities while fostering an empowered culture of quality across all functions
Main Responsibilities:
- Author, review, and approve SOPs, protocols, and quality records to ensure compliance with regulations and international standards.
- Evaluate Quality Systems and procedures, identifying areas for improvement and supporting process enhancements.
- Assist with GMP training, internal/external audits, and maintaining the customer audit process.
- Support audit and inspection activities (Client, Internal, Regulatory) and lead backroom activities during audits.
- Coordinate and track risk assessments, Quality metrics, and discrepancy reports (e.g., deviations, CAPAs, complaints).
- Maintain and manage Electronic Management Systems related to Quality.
- Communicate effectively with team members and contribute as a collaborative team player.
- Travel as needed for audits, conferences, and training opportunities.
- Adhere to quality standards, company policies, and ethical guidelines while maintaining professionalism.
Requirements:
- Between 5-10 years of experience in a GMP-regulated biopharmaceutical facility or equivalent.
- Minimum of a B.S. degree in Life Sciences or a related discipline.
- Strong knowledge of industry standards and regulatory requirements for biologics and parenteral products in clinical development and commercial stages.
- Proficiency in GMP regulations (US, EU, and ROW), good documentation practices, cGMP, 21 CFR, USP, and other applicable standards and guidance.
- Detail-oriented with excellent analytical, written, and verbal communication skills.
- Familiarity with Microsoft Office applications.
- Ability to work well under pressure, independently manage multiple tasks, and maintain organization with strong communication skills.
This is a fantastic opportunity to be a key part of a cutting-edge CDMO, helping to shape the future of the organization while ensuring the delivery of top-quality products in a safe and compliant environment.
Apply today to take the next step in your leadership journey.