QA Manager, QA Validation

at  Fujifilm

THE WORK WE DO AT FDB HAS NEVER BEEN MORE IMPORTANT—AND 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 PEOPLE’S 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

QUALIFICATIONS:

• Master’s degree preferably in a science-related field with 5+ years of related experience, including qualification validation experience; OR,
• Bachelor’s degree in Biochemistry, Biology, Biotechnology, Microbiology or similar education and 7+ years of related experience, including qualification validation experience, OR;
• Associate’s degree in Biochemistry, Biology, Biotechnology, Microbiology or similar education and 9+ years of related experience, including qualification validation experience.
• 4+ years of supervisory experience.
• 4+ years of cGMP experience.
• Single Use and Process Validation preferred.
• Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new construction final qualification requirements of TOP’s for GMP facilities.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Ability to set personal performance goals and provide input to departmental objectives.
• Develop staff to maximize contributions to the team and the company.
• Ability to multitask and easily prioritize work.
• Ability to work independently with little supervision.
• Proficient in Microsoft Excel, Word and PowerPoint.
• Must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Lifting up to 25 pounds on occasion.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Must be willing to work flexible hours.
• Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory.

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 P&ID’s 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 quality or regulatory compliance.
• All other duties as assigned.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Lifting up to 25 pounds on occasion.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Must be willing to work flexible hours.
• Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory