This position will collaborate internally and externally to oversee cGMP activities as required to maintain compliance with the Quality Management System and critical quality systems for the manufacture, packaging, release, and distribution of investigational materials. We are seeking an experienced QA individual that will collaborate with our internal clinical supply and CMC teams and well as our GMP suppliers.
- Review, adjudicate, and prepare documentation for batch record disposition
- Master batch record review including in-process controls
- Review GMP analytical documentation including analytical methods, validation protocols, SOPs, reports, etc.
- Develop, implement, and maintain standard operating procedures (SOP) for quality assurance systems oversight of contract manufacturing (CMO) and contract testing sites, and release of drug substance, drug product and finished drug product
- Review documents associated with manufacturing and lab deviations, investigations, OOS results, change controls and CAPAs
- Provide QA support for manufacturing and testing, including Person-in-Plant, when acceptable to be on site
- Support internal and external audits (GMP suppliers), as required
- Support the preparation, coordination, and management of regulatory agency inspections
- Support continuous improvement initiatives including existing quality procedure workflows, aspects of the quality management system, etc.
- Approve shipment of CytomX materials, as requested
- Assist QA management with departmental needs
- Reviews and improves existing quality procedure workflows, identifies areas of improvement for efficiency and compliance
- Must have a Bachelor in life science and 5+ years of relevant QA experience in the biopharmaceutical industry with 3+ years of quality oversight of CMOs/CTOs.
- Must have experience with parenteral drug development, manufacturing and testing
- Must have QA experience with manufacturing controls for sterile parenteral biologics, including batch record review
- Experience interacting and directing GMP suppliers
- Strong knowledge of FDA, guidance documents, ICH and EU directives on GMP manufacturing of clinical trial materials
- Must have strong understanding of regulations (US & EU) to be flexible and adaptable to fast-paced environment
- The ability to communicate well both verbally and in writing with all levels both inside and outside of the organization
- Must be willing to travel domestically and internationally (15%+), as needed.
- Experience with eQMS such as Veeva, Master Control, etc is a plus
- Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability, and Fun
- The ideal candidate can learn quickly in a fast-paced environment, be diligent, well organized and thorough in their reviews