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Job Title: Senior QA Manager
Location: California
Discipline: QA
Reference: VUWK3456
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Description: Process Development/ Pharmaceuticals / molecules / clinical systems /
VUWK3456
Senior QA Manager
Bay Area, CA
Senior QA Manager directs a QA group responsible for the building,
maintenance, and improvement of compliant and robust Clinical GMP
Systems
The Senior QA Manager oversees QA operational activities for small molecule
clinical products produced in Bay Area of California or externally. The
position
also oversees QA Validation, Lot Disposition, Document Management,
and Change Control for small molecules / collaborate with other QA gps
on development of global documents to meet expanding business needs.
Identify system and process owners, conduct periodic reassessments,
evaluation of change requests/ interpretation of regulatory language
and applicability of requirements / partner with site and business
unit local system owners to identify compliance, productivity, and
efficiency issues with these systems and find resolution in the interst of
the company
Implement and manage all required quality systems for early phase small
molecule production, leveraging existing biologic product or corporate
systems where appropriate.
Oversee production of early phase API, including documentation and lot
release.
Implement and maintain a system to facilitate introduction of new raw
materials, including reagents and components used in manufacture of small
molecule clinical products.
Assure appropriate investigation of significant manufacturing events.
Direct and develop Small Molecule QA group.
Assure appropriate equipment qualification and maintenance in production and
Quality Control
General systems support for GMP activities, including LIMS, DMS,
Change Control, etc.
Qualifications:
Experience/Education/Skills
(Minimum requirements)
* B.S. or B.A. degree with demonstrated 12 years of
relevant experience in the pharmaceutical industry
* Minimum 7 years managerial experience
* Sound knowledge of cGMPs and State regulations applicable to
small molecule production.
* Demonstrated knowledge and execution of Quality operations
and processes
* Experience in directing and leading successful quality
organization functions
* Ability to interpret and relate Quality standards for
implementation and review
Apply to: Click Here
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