GLP Quality Assurance Manager, Contract Research Organization

Job Description

Job Description

Job Title: Quality Assurance Manager GLP

About the Role: The Quality Assurance Manager is responsible for managing daily QA activities and leading a small team of QA Associates. Reporting remotely to the QA Director, this role involves ensuring comprehensive audits of nonclinical and laboratory studies to verify compliance with protocols, Standard Operating Procedures (SOPs), Good Laboratory Practices (GLP) (21 CFR Part 58 and Part 11), and applicable regulatory requirements. The QA Manager will also provide leadership, mentorship, and guidance to team members, driving quality assurance best practices within the facility.

Key Responsibilities:

• Oversee and manage QA operations, ensuring thorough audits across various disciplines including non-clinical GLP studies, method validations, vendor qualifications, and equipment/software validations.
• Act as the primary onsite QA leader, addressing day-to-day operational issues and compliance questions in the absence of the remote QA Director.
• Conduct and oversee in-life, process, data, and facility audits to verify adherence to regulatory standards.
• Lead audits and supervise QA investigations, ensuring robust documentation and timely resolution.
• Maintain accurate, organized audit records and computerized documentation systems to effectively support audit activities and regulatory inspections.
• Identify and communicate quality and compliance trends, proactively recommending and implementing process improvements.
• Provide expert guidance and interpretations of GLP regulations, supporting the development and execution of corrective actions and SOP enhancements.
• Serve as the primary point of contact during external client and regulatory audits, effectively representing the QA department.
• Participate in project planning, risk assessments, and strategic implementation activities.
• Develop and deliver GLP compliance training to facility staff, ensuring alignment with regulatory requirements and industry best practices.
• Engage actively in professional development activities, including industry seminars, certification programs, and ongoing training.

Qualifications and Experience:

• Bachelor's degree or higher in a scientific discipline or an equivalent combination of education and experience.
• Minimum of 5 years of Quality Assurance experience, specifically within GLP-regulated environments, including experience in a supervisory or management role.
• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (Certified Quality Auditor) strongly preferred.
• Proven experience managing QA teams, leading audits, managing investigations, and independently hosting client or regulatory audits in a contract research organization
• Familiarity with computerized system validation processes and requirements is advantageous.
• Comprehensive understanding of the preclinical drug development process and associated regulatory expectations.

Skills and Competencies:

• Strong leadership and team management capabilities.
• Excellent organizational, problem-solving, and decision-making skills.
• Exceptional communication and interpersonal abilities, able to effectively engage stakeholders across all organizational levels.
• High level of detail orientation and ability to manage multiple tasks in a fast-paced environment.
• Proficiency with Microsoft Office Suite and QA documentation management systems.

Join Our Team: If you're an experienced Quality Assurance professional passionate about leading teams and driving compliance excellence, we invite you to apply. Become a key leader in our organization, ensuring the integrity and quality of groundbreaking preclinical research.