Executive Director, Quality Assurance, Good Manufacturing Practice (GMP)

About the Company

Emerging biopharmaceutical company

Industry Biotechnology

Type Public Company

Founded 1996

Employees 201-500

Categories

Biopharma Biotechnology Genetics Health Care Medical Pharmaceutical Pharmaceuticals Medicine Chemical Products Manufacturing Consulting & Professional Services

Specialties

drug discovery ion channels neurology epilepsy drug development neuroscience biotechnology biopharmaceuticals seizures focal onset seizures mdd psychiatry depression neuropsychiatry tonic-clonic seizures fos pgtsc sodium channels and potassium channels

About the Role

The Company is seeking an Executive Director for Quality Assurance with a focus on GMP. The successful candidate will be a key member of the Quality leadership team and the R&D Operations group, ensuring that quality program requirements are met across all clinical and commercial phases. This role demands a professional with a strong background in quality and manufacturing, particularly in the context of small molecule products. The Executive Director will be responsible for all quality-related matters at a CMO, leading and supporting external quality activities, and collaborating with internal CMC functions to ensure cGMP compliance. Proven leadership skills in a fast-paced environment, the ability to interact with all levels of staff and external partners, and a commitment to promoting a quality mindset throughout the organization are essential.

Applicants for the Executive Director position should have a Bachelor’s degree in a life sciences discipline, with at least 12 years' experience in GMP quality leadership. A strong understanding of small molecule manufacturing, particularly solid oral dosage, and experience with global GxP expectations are required. The role also involves representing the Quality function in various meetings, attending to quality system and product reviews, and ensuring compliance with data integrity. The ideal candidate will be goal-oriented, with the ability to troubleshoot and resolve problems, and will champion continuous improvement in total quality management. Strong interpersonal skills, the ability to lead high-performance teams, and a proactive, solution-focused communication style are necessary. The Executive Director will also be responsible for budget management, and strategic planning, and may be involved in the recruitment and development of direct reports.

Hiring Manager Title Senior Vice President, Quality Assurance

Travel Percent Less than 10%

Functions

CEO/President Non-Profit Management