Director of Quality, Cell Therapy
Position Role and Responsibilities:
This position is responsible for leading the quality operations and support compliance activities of clinical development and commercialization of Angiocrine’s engineered cell therapy products.
- Primary role is to serve as quality leader of Angiocrine’s cellular therapeutic programs.
- Develop and maintain essential quality systems for both clinical development and commercial environments, including document control (including SOPs), change control, CAPA, training, validation, and auditing.
- Provide QA oversight and day-to-day management of in-house QC lab.
- Provide QA oversight of CMOs. Negotiate quality agreements, and conduct CMO qualification.
- Manage implementation of required changes with CMO to meet cGMP requirements and internal standards.
- Work closely with the company's CMC team, assuring accurate and timely flow of information including, but not limited to: specifications, batch records, and product release for cellular drug products, all in compliance with company standards and cGMP procedures.
- Review and approval of development, transfer, master and study specific validation protocols and reports.
- Verification of process data and approval of technical protocols, reports, and chemistry, manufacturing and control sections of regulatory submissions.
- Approval of production related activities via approval of: specifications, master batch records, change controls, sampling and testing plans, stability study protocols and reports in compliance with cGMP regulations.
- Lead deviation and out of specification investigations.
- Lead internal quality audits to assess Angiocrine’s compliance to regulations. Facilitate and assist with the preparation, coordination, and management of regulatory inspections of Angiocrine and contract manufacturers.
- BS in biology or related field with an advanced degree desirable
- Minimum of 10 years' progressive quality assurance experience in clinical or commercial pharmaceutical/biotech operations and development; experience in both development and commercial operations required
- Advanced knowledge of quality assurance principles, concepts, industry practices and standards
- Strong proven hands-on experiences with GLP, GMP, GCP compliance matters and contractor management in the bio/pharma industry
- Experience working with contract manufacturers
- Experience with the regulatory submission and approval process
- Previous experience with building quality systems and company-wide SOP systems for all phases of clinical development and commercialization
- Independent and self-directed working style
- Excellent communication and organization skills
- Ability to work in a high paced team environment.
- Must embrace positive, pro-active and “no-excuses” style of execution—must emanate ‘can-do’ attitude.
Additional Desired Skills and Knowledge
- Direct experience with FDA regulations in cell therapy manufacturing
- Strong computer skills with Word and Excel and other electronic manufacturing systems.
- Proficiency with eCTD software, document management systems, review management/version control software, Microsoft Office and Adobe Acrobat
- Detail oriented team player with effective planning, organization and execution skills.
- Good organization and time management skills.
This position is based in San Diego, CA.
Angiocrine is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.