Sr. Director Of Quality (Pharma/Biotech)

Sr. Director Of Quality (Pharma/Biotech)
Company:

Jobot


Sr. Director Of Quality (Pharma/Biotech)

Details of the offer

Sr. Director of Quality (Pharma/Biotech)
This Jobot Job is hosted by: Emmet Nitto
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $170,000 - $190,000
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. Director of Quality (Pharma/Biotech) to join our growing team.
Why join us?
Competitive Salary!
Great Benefits Package!
The Opportunity to Join an Amazing Team!
Job Details
Minimum of 10 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.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.


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