A bit about us:
Based in San Diego, CA we are a Biotech Start-Up developing personalized cell therapy, inducing stem cells to treat various neurological conditions. We use personalized regenerative medicine enabling technologies for patient specific induced pluripotent stem cell-based therapies. We are looking for a Sr. QA Manager (Pharma/Biotech) (Pharma/Biotech) to join our growing team.Why join us?
- Competitive Salary!
- Great Benefits Package!
- The Opportunity to Join an Amazing Team!
- Minimum of 5+ years of progressive Quality department experience in pharmaceutical or biotechnology company
- Minimum of 4 years of management experience building and overseeing a Quality Department.
- Experience working with biological products is required
- Experience with clinical QA responsibilities is a plus; including experience with implementing SOPs to ensure GCP for clinical conduct and oversight
- Ability to travel up to 10% time based on requirement to support contracted labs and manufacturers
- Strong knowledge of FDA and ICH Guidelines including cGMP, GCP and GLP, method qualification and validation requirements, and policies regarding reference standard and specification development
- Experience with Contact Manufacturing Organizations (CMO) relating to manufacture and packaging/labeling of clinical trial materials and commercial product
- Experience managing outsourced QC and characterization testing is required. Experience with initiation of Quality systems and GMP-compliant QC laboratories is preferred.
- Strong scientific credentials, and ability to critically assess technical and compliance risks and opportunities, problem solve, and communicate complex topics
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel at all levels
- Effective written and verbal communication skills and computer skills are required
- Strong problem solving, risk assessment and impact analysis abilities.
- Well organized with the ability to multitask in a fast paced environment.
- Proficiency with MS Office applications required.
- Experience with enterprise applications (example: MasterControl, Documentum, Trackwise, LIMS, SAP) preferred.