Job Information
FUJIFILM DIOSYNTH BIOTECHNOLOGIES Quality Assurance Manager Validation in College Station, Texas
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QA Manager, QA Validation
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Job LocationsUS-TX-College Station
Posted Date
1 week ago
(12/26/2024 12:31 PM)
Requisition ID : 2024-27869
Category : Quality Assurance
Company (Portal Searching) : FUJIFILM Diosynth Biotechnologies
Overview
The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.
External US
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
The Quality Assurance (QA) Manager, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, and discrepancies. The Manager will handle all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.
Reports to
Director, QA Compliance
Work Location
College Station, TX
Primary Responsibilities:
Leadership
- Provides direction to the validation team to ensure the organization is complying with local and global quality standards, regulatory requirements and partner commitments.
- Develop, motivate and lead direct reports towards achieving organizational and individual goals.
- Work collaboratively with management of other site functions to instill a Quality Culture by coaching in the application of GMP Principles including the underlying rational of those principles.
New Business Growth
- Support client due diligence and Quality audits as well as regulatory inspections.
Compliance
Reviews and approves master plans, pre/post approval of qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions.
Participate in design reviews, and have experience in reading PandIDs and various engineering drawings.
Coordinate with Validation, Metrology, Facilities, Engineering, on a daily bases to ensure any GMP protocols, requirements, etc. are completed in a timely manner
Utilize investigative techniques to determine root causes of discrepancies and proper corrective and preventative actions.
Promptly notify Senior Management of potential quality or regulatory issues that may affect product qual
