Biosciences Quality Assurance

W. L. Gore & Associates, Inc.; Flagstaff (AZ); On-site; USD 75,000 - 105,000; Full time

Job summary

W. L. Gore & Associates, Inc. seeks a Biosciences Quality Assurance professional to join the Biosciences Operations Team Quality Assurance Unit at its Flagstaff, AZ facility. You will help develop and maintain quality procedures and ensure regulatory compliance for nonclinical research.

You will conduct audits, provide training, support external inspections, and drive continuous improvement of quality systems to enable high-quality, compliant scientific work across bioscience operations.

Qualifications

• Bachelor's degree in life sciences, quality, engineering, regulatory affairs, or related field; 2+ years in quality systems, regulated research, audits, or compliance; or 6+ years in a regulated industry.
• Knowledge of GLP requirements or applicable quality system regulations.
• Ability to author, revise, and maintain controlled procedures and records.
• Ability to train, coach, or facilitate learning on quality system topics.
• Ability to interpret regulatory requirements and implement risk-based solutions.

Responsibilities

• Implement and improve quality systems, procedures, and programs for Biosciences research and operations.
• Conduct internal audits and assessments to ensure regulatory and quality compliance.
• Support external audits, inspections, accreditation reviews, and regulatory assessments.
• Deliver training and oversee Biosciences training programs and records.
• Collaborate with leaders to identify training needs and process improvements.
• Provide guidance on regulatory requirements, CAPA, investigations, and risk assessments.
• Administer IACUC and compliance activities, including protocol oversight.
• Manage document control, change control, event management, and eQMS processes.
• Develop quality metrics and reports to support compliance and performance.
• Collaborate cross-functionally to drive continuous improvement and risk reduction.

Skills

Quality systems

Audits

Training

Regulatory compliance

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Tools

eQMS

Document control software

Change control software

Job description

About the Role

We are looking for a Biosciences Quality Assurance professional to join our team. In this role, you will be part of the Biosciences Operations Team Quality Assurance Unit, which is responsible for the development, management, and continuous improvement of quality procedures and systems that ensure compliance with applicable regulations and standards supporting research conducted by the Biosciences Team. You will partner with research, veterinary, technical, and operational teams to maintain inspection readiness, assess compliance, strengthen quality system processes, and translate regulatory expectations into practical, risk-based solutions. Through audits, assessments, quality guidance, metrics, and cross-functional collaboration, you will help reduce risk, improve operational performance, and enable high-quality, compliant scientific work. This highly collaborative role offers broad exposure to regulated nonclinical research and the opportunity to make a meaningful impact on the effectiveness and continued advancement of Biosciences operations.

This role will be located at our facility in Flagstaff, Arizona.

Responsibilities

• Implement, maintain, and continuously improve quality systems, procedures, and programs supporting Biosciences research, animal care, and operational activities
• Conduct internal audits and assessments to ensure compliance with applicable regulations, quality standards, animal welfare requirements, and organizational policies
• Support the planning, hosting, and response activities associated with external audits, inspections, accreditation reviews, and regulatory assessments
• Deliver training, coaching, and oversight of the Biosciences training program, including curricula, qualification requirements, training records, and effectiveness monitoring
• Partner with functional leaders and subject matter experts to identify training needs and support implementation of new or revised processes and procedures
• Provide guidance on regulatory requirements, quality system expectations, investigations, nonconformances, CAPA, risk assessments, and related compliance activities
• Administer and support the Institutional Animal Care and Use Committee (IACUC) and compliance activities, including program reviews, protocol oversight processes, corrective actions, and implementation of animal care and use requirements
• Administer and support quality system processes including document control, change control, event management, training, CAPA, root cause analysis, risk assessments, continuous improvement efforts, and electronic quality management systems
• Develop and communicate quality metrics, trends, reports, and recommendations to support compliance, animal welfare, training effectiveness, and operational performance
• Collaborate with cross-functional teams to drive continuous improvement, risk reduction, and practical, science-based solutions that support compliant and efficient Biosciences operations

Required Qualifications

• Bachelor's degree in life sciences, quality, engineering, regulatory affairs, or a related field with a minimum of 2 years of experience in quality systems, regulated research, laboratory operations, audits, inspections, or compliance reviews; or a minimum of 6 years of directly relevant experience supporting the processes and responsibilities outlined above in the medical device industry or another relevant regulated industry may be considered
• Working knowledge of Good Laboratory Practice (GLP) requirements and applicable quality system regulations, standards, or guidance documents
• Demonstrated ability to author, revise, review, and/or maintain controlled procedures, records, and quality system documentation
• Demonstrated ability to train, coach, or facilitate learning on quality system requirements, regulatory expectations, and operational procedures
• Ability to interpret regulatory and quality requirements, assess compliance risks, and implement practical, risk-based solutions in collaboration with process owners
• Strong verbal, written, and presentation skills with the ability to communicate effectively with technical staff, study personnel, leadership, inspectors, internal and stakeholders
• Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic operational environment
• Ability to work effectively across functions, influence outcomes and build collaborative relationships with diverse stakeholders
• Ability to support of Biosciences operations and travel up to 5% as needed

Desired Qualifications

• Minimum of 2 years of experience supporting nonclinical, animal research, veterinary, laboratory, or regulated scientific operations, including direct support of studies under 21 CFR Part 58 and familiarity with applicable DEA, USDA, Animal Welfare Act, IACUC, or related requirements
• Minimum of 2 years of direct experience supporting regulatory inspections and/or independently planning, conducting, documenting, and following up on internal or supplier audits
• Minimum of 2 years of hands-on experience administering electronic quality management systems, including document control and change management workflows