Location:
San Diego, CA
Posted Date:
4/2/2012
Position Type:
FULL
Job Code:
QA Manager/Associate Director
Salary:
DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Description
Primary Responsibilities:
This position will be responsible to support all QA activities including but not limited to lot release and upkeep and improvements of Quality Systems and oversight of PaxVax manufacturing and testing site(s) or contracted GMP, GLP, GCLP, GCP activities as assigned.
Specific Responsibilities:
Oversight of contract manufacturing and testing facilities for compliant release of clinical products. This includes but not limited to: Batch records review and approval, assay development/method qualification & validation for testing clinical batches, oversight of tech transfer of manufacturing and testing activities.
Lead the timely resolution and successful closure of deviations/CAPAs/ Investigations, and NCMRs
Support the review of QC testing results and production of COAs
Drive the lot release process for timely release of products
Support the validation program and internal and external audits
Support the vendor qualification process
QA oversight of the clinical operations as assigned
Oversee other QA processes such as receipt and release of raw materials and automation activities, and management of other ongoing projects as assigned by supervisor
Requirements
Minimum of ten years in a GMP biotechnology or pharmaceutical company environment (in GMP QA and or QC of Biologics Products; direct QA experience and supervisory experience is a plus)
Thorough knowledge of FDA regulations as they apply to biologics
Ability to work in a fast paced team environment with minimal supervision on multiple projects
Excellent written and verbal communication skills
Experience in Oral Solid Dosage Products, Vaccines, and automation/LIMS implementation is a plus
About PaxVax:
PaxVax is an innovative and fast-paced vaccine start-up company developing vaccine candidates against several important infectious diseases, including influenza, cholera and HIV. The Company's first vaccine candidate for H5N1 recently completed a successful Phase 1 clinical trial. The R&D team has made several other vaccine candidate adenoviruses with a 100% success rate in making adenovirus based vectors. In the coming year PaxVax plans to initiate three additional clinical trials on its candidates. The Company has committed funding of over $30 million to support its operation including R&D and its own licensed GMP manufacturing facility. PaxVax has 45 employees organized by functional departments and cross-functional project teams for each of its vaccine candidates. PaxVax is a double bottom line business focused on delivering both financial as well as social returns in global health.
Benefits:
Company sponsored employee medical and dental benefits, 401k, STD & LTD coverage. Competitive compensation. No relocation assistance is available.
PaxVax is an Equal Opportunity Employer.
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