Director, Clinical Quality Assurance

Paragon Biosciences LLC • Chicago, IL

26d • $205,000 - $225,000

About The Position

The Director, GCP/GLP Quality Assurance provides strategic leadership and enterprise-level oversight of R&D Quality Assurance activities supporting Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). This role is responsible for ensuring compliance with ICH guidelines, FDA regulations, and global regulatory requirements, while driving a robust and continuously improving Quality Management System (QMS). The position requires a seasoned people leader with formal leadership training and a proven track record of building, developing, and mentoring high-performing QA teams, as well as influencing cross-functional stakeholders to uphold quality, inspection readiness, and regulatory excellence across the organization.

Requirements

• Minimum BS/BA degree and a minimum of seven (7) years of pharmaceutical clinical research or development experience in the pharmaceutical industry; an advanced degree and a minimum five (S) years of equivalent experience preferred of equivalent experience preferred
• Documented leadership training and/or equivalent leadership experience, including people development and organizational leadership.
• Understanding of and practical experience with regulatory regulations pertaining to FDA CFR, ICH guidelines, GCP and GLP.
• Knowledge of clinical development process and the related regulations/guidelines.
• Experience with effectively managing FDA inspections, working with regulators and customer audits.
• Auditing experience across full range of audit types such as: Investigator sites, CROs, Phase I Units, laboratories, external and internal systems and computer system validation audits.
• Ability to take initiative, delegate authority, and be persistent in pursuing resolutions to quality issues.
• Ability to work with multi-disciplinary teams and with individuals at all levels.
• Demonstrated ability to work independently and manage variable workloads.
• Good verbal, written, and presentation skills
• Demonstrated ability to manage internal and external resources.
• Development and oversight of the department budget.
• Ability to mentor, coach and manage people.

Responsibilities

• Provide strategic leadership and direction for GCP and GLP Quality Assurance across the organization.
• Serve as a quality leader and trusted advisor to AVP of Quality Assurance and cross-functional stakeholders.
• Promote a strong, sustainable culture of quality, compliance, and accountability throughout the clinical research organization.
• Lead and direct all GCP/GLP QA activities to ensure compliance with FDA, ICH, EMA, and other global regulatory requirements.
• Develop, implement and maintain oversight and accountability for quality and regulatory compliance of all clinical and nonclinical systems, processes, vendors, and outcomes.
• Ensure continuous inspection readiness and regulatory compliance across all programs.
• Establish, maintain, and enhance an efficient and effective GCP/GLP Quality Management System.
• Oversee the development, approval, and lifecycle management of SOPs, policies, and procedure.
• Drive risk-based quality strategies and continuous improvement initiatives.
• Oversee, lead & conduct internal, external, CRO, vendor, laboratory, and investigator site audits.
• Serve as the secondary QA lead during regulatory authority inspections, including preparation, conduct, response, and remediation.
• Write, review and approve audit reports, CAPAs, CAPA resolution and effectiveness assessments
• Provide QA oversight of clinical trials, nonclinical studies, data integrity, and documentation.
• Ensure appropriate qualification, oversight, and performance management of CROs and other third-party vendors.
• Partner closely with Clinical Operations, Regulatory Affairs, Nonclinical, and other functions to proactively identify and mitigate quality risks.
• Support and develop and provide independent periodic reports to AVP Quality Assurance & management on overall compliance status. Assist in the preparation, conduct and management of management review meetings.
• Lead, manage, and develop a team of QA professionals, including hiring, performance management, coaching, mentoring, and succession planning.
• Set clear goals, expectations, and development plans aligned with organizational objectives.
• Ensure team members receive appropriate training in GCP, GLP, and quality systems
• Development, implementation and management of the training program; conduct training for awareness and adherence to GCP and GLP regulations as needed.
• Foster collaboration, accountability, and professional growth within the QA organization.

Benefits

• This position will also be eligible for a discretionary bonus.
• Emalex Biosciences offers a comprehensive benefits package, including group medical, dental and vision insurance, emotional health support, 401k, short and long-term disability, life and AD&D insurance, and flexible spending accounts.

What This Job Offers

• Job Type: Full-time
• Career Level: Director