QA Manager, QA Validation

Fujifilm; College Station (TX); On-site; USD 120,000 - 170,000; Full time

Job summary

Fujifilm in College Station, TX seeks a Quality Assurance Manager to lead QA Validation and ensure GMP-compliant commissioning, qualification, and validation activities in a highly regulated biotechnologies setting.

The role requires extensive cGMP experience, oversight of master plans, deviations, and root-cause investigations, along with mentoring staff and coordinating cross-functional teams to sustain quality systems and regulatory readiness.

Qualifications

• Master’s degree in a science-related field with 5+ years of related experience, including qualification validation experience.
• Bachelor’s degree in Biochemistry, Biology, Biotechnology, Microbiology or similar education and 7+ years of related experience, including qualification validation experience.
• 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 required.
• 4+ years of cGMP experience required.
• 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 multitask and work independently; capable of leading teams and setting objectives.
• Proficient in Microsoft Excel, Word and PowerPoint; working knowledge of cGMP regulations.

Responsibilities

• Provides direction to the validation team to ensure compliance with local and global quality standards, regulatory requirements and partner commitments.
• Develop, motivate and lead direct reports towards achieving organizational and individual goals.
• Coaching in the application of GMP Principles and the rationale behind them.
• Support client due diligence and Quality audits as well as regulatory inspections.
• Reviews and approves master plans, pre/post approval of qualification and validation protocols, reports and associated data.
• Reviews and approves qualification and validation deviations and discrepancies; supports investigations and corrective actions.
• Participate in design reviews and read P&ID’s and engineering drawings.
• Coordinate with Validation, Metrology, Facilities, Engineering daily to ensure GMP protocols are completed timely.
• Utilize investigative techniques to determine root causes of discrepancies and proper CAPAs.
• Notify Senior Management of potential quality or regulatory issues.

Skills

Leadership and mentoring

GxP / cGMP knowledge

Regulatory compliance

Quality systems

Audit support

Education

Master’s degree in science

Bachelor’s degree in Biochemistry/biology/biotechnology/microbiology

Associate’s degree in Biochemistry/biology/biotechnology/microbiology

Tools

Microsoft Excel

PowerPoint

Word

Job description

Position Overview

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 Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

Reports to Director, QA Compliance

Work Location College Station, TX

Job Description

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 basis 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.

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 required.
• 4+ years of cGMP experience required.
• 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, and Gemba.

Physical Requirements

• 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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail] or [phone]).