Job Description

Position Summary

The Director/Sr. Director of Quality Assurance (Final title TBD) will be responsible for overseeing GxP and ensuring the compliance of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) across the organization. The role involves the day-to-day management of quality operations, including assuring all areas operate in support of the company and department objectives and compliance with applicable regulations and standards. Role includes the oversight of incoming inspection, product acceptance testing and release, document control, supplier management, manufacturing process verifications/validations, as well as associated nonconformance control, supplier corrective actions, and CAPAs. This position requires strategic leadership and collaboration cross-functionally with clinical, manufacturing, regulatory, and R&D teams throughout the product development lifecycle, applying hands-on management, and a deep understanding of regulatory requirements and quality systems in the pharmaceutical/biotech industry. 

Responsibilities

• Provide GxP compliance leadership through the implementation, maintenance, and continuous improvement of GxP quality systems to ensure compliance with applicable regulatory requirements, including GMP, GLP, and GCP, across clinical, laboratory, and manufacturing environments.
• Develop and execute the company's GxP quality strategy, ensuring all internal and external activities comply with regulatory standards. Provide expert guidance on quality risk management, regulatory inspections, and audit preparation.
• Work closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Manufacturing, Nonclinical and Research & Development, to align quality standards with organizational goals and ensure seamless execution of clinical trials, manufacturing processes, and laboratory activities.
• Maintain inspection readiness for domestic and foreign regulatory and statutory requirements. 
• Lead and manage internal and external audits to ensure ongoing compliance and to address any findings or corrective actions. Oversee preparation for regulatory inspections and develop robust audit responses.
• Conduct regular audits of GxP vendors and oversee quality agreements with Contract Development Manufacturing Organizations/Contract Research Organizations.
• Identify compliance risk and recommend mitigations.
• Oversee the management and continuous improvement of the company’s internal Quality Management System (QMS) including document control, CAPA management, deviations, product release, investigations, change controls, and handling out-of-specification results and non-conformance reports (NCRs).
• Keep the organization informed on industry trends, regulatory updates, and best practices.
• Lead the development and delivery of GxP training programs to ensure a deep understanding of quality systems and regulatory requirements across the organization.
• Foster a culture of quality, compliance, continuous improvement, and cross functional team engagement throughout the organization.
• Manage consultants and contractors, as needed.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, or related field required, advanced degree preferred.
• Minimum of 15 years of experience in GxP Quality Assurance, including at least 10 years in a leadership role within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in GMP, GCP, and GLP compliance, quality/risk management principles and a strong understanding of global regulatory standards (FDA, EMA, ICH).
• Experience with drug development and clinical trials, as well as a solid understanding of clinical trial operations, manufacturing processes, and laboratory testing.
• Strong leadership skills with a proven ability to manage consultants/vendors, employees, drive change, and influence across organizational levels.
• Skilled in authoring, reviewing, and approving SOPs and other controlled documentation for compliance with applicable regulations.
• Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with internal & external team members and stakeholders.
• Excellent communication, writing, problem-solving, and organizational skills.
• Ability to travel domestically and internationally.

The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. Elion Therapeutics reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.

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