Overview
Associate Director, QA Validation (On-Site in College Station, TX) Jobs in United States at FUJIFILM Biotechnologies
Title: Associate Director, QA Validation (On-Site in College Station, TX)
Company: FUJIFILM Biotechnologies
Location: United States
Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking a Associate Director, QA Validation to oversee the review and approval of commissioning, qualification, and validation protocols, reports, and discrepancies. This role will ensure compliance with FUJIFILM Diosynth Biotechnologies’ quality policies, site SOPs, and regulatory requirements while providing strategic leadership to the validation team.
Job Title: Quality Assurance (QA) Validation, Associate Director
Reports to: Director, Quality Assurance Compliance
Essential Functions:
Leadership
Develop, implement and maintain QA oversight activities to meet all GMP guidance and direction to the validation team to ensure adherence to local and global quality standards, regulatory requirements and partner commitments.
Maintain an operational tier structure to ensure the site is continuously complying with standard operating procedures, processes, regulatory requirements, and partner commitments.
Identify and implement best practices to improve right first time (RFT) execution.
Develop, mentor, motivate and lead direct reports to achieve individual and organizational objectives.
Collaborate with cross functional teams and management to instill a “Quality Culture” by coaching personnel on GMP principles and their applications.
QA Validation and Compliance
Review and approve master validation plans, qualification/validation protocols, summary reports, and associated data to ensure regulatory and SOP compliance.
Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
Oversee and approve validation deviations and discrepancies, supporting investigations and corrective actions, and participate in design reviews, assess P&IDs, and review engineering drawings for compliance.
Collaborate with Validation, Metrology, Facilities, and Engineering teams to ensure GMP protocols and requirements are met in a timely manner.
New Business Growth
Lead the effort to support client due diligence, quality audits, and regulatory inspections to ensure compliance with industry and company standards.
Perform other duties as assigned.
Required Skills & Abilities:
Proven ability to motivate and lead teams instilling our Company philosophy, culture, and People Fundamentals.
Experience in qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, HVAC systems, and new GMP facility construction.
Strong understanding of cGMP regulations for the production of drug, biologics, or vaccine products.
Excellent written and verbal communication skills, with strong organizational and analytical abilities
Excellent organizational, analytical, data review and report writing skills.
Ability to prioritize tasks, multitask effectively, and work independently with minimal supervision
Develop staff to maximize contributions to the team and the company.
Proficiency in Microsoft Excel, Word and PowerPoint.
Qualifications:
Bachelor’s degree with eight (8) years of relevant experience in a heavily regulated environment such as pharmaceutical, biotechnology, or supporting a CDMO environment; OR
Associate’s degree with ten (10) years of relevant experience in a heavily regulated environment such as pharmaceutical, biotechnology, or supporting a CDMO environment.
At least four (4) years of experience in a leadership or prior supervisory/managerial role.
A minimum of five (5) years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.
Preferred Qualifications:
Degree in Biology, Chemistry or Engineering.
Single Use and Process Validation a plus.
Previous leadership experience in Quality Control or Quality Assurance.
