Executive Director, Quality Assurance

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

• rare disease
• drug discovery
• ion channels
• neurology
• epilepsy
• drug development
• orphan disease
• neuroscience
• biotechnology
• biopharmaceuticals
• seizures
• focal onset seizures
• and MDD

About the Role

The Company is a leading biopharmaceutical firm dedicated to the discovery and development of innovative therapeutics for a range of medical conditions. They are currently seeking an Executive Director, Quality Assurance, GMP to join their team. The successful candidate will be a pivotal member of the Quality leadership team and will play a key role in the collaborative R&D Operations group, which includes Program Management, CMC, Regulatory, and Quality functions. The role demands an individual with an extensive background in quality and manufacturing across all clinical phases to commercial, ensuring that all quality program requirements are met.The Executive Director will be responsible for all quality-related matters related to manufacturing, testing, and release at a CMO, acting as the technical subject matter expert for all GMP-related regulations and guidelines. They will lead and support activities related to external quality, collaborate with internal CMC functions, and ensure that quality policies and objectives are understood and maintained for all GMP roles. The ideal candidate should have a bachelor's degree in a life sciences discipline, with over 12 years of experience in GMP quality leadership positions, a strong understanding of small molecule manufacturing, and a proven track record of leading high-performance teams in a fast-paced, deadline-driven environment. Strong interpersonal skills, extensive GxP knowledge, and the ability to promote a quality mindset throughout the organization are essential.Candidates for this role at the company should possess a bachelor's degree in a life sciences discipline and have at least 12 years of experience in GMP quality leadership positions. A strong understanding of small molecule manufacturing, particularly in solid oral dosage, is required, and experience with a small virtual company is a plus. The role demands a leader with a strong knowledge of global GxP expectations, QP requirements, and the ability to effectively organize, multitask, and work in a fast-paced, deadline-driven environment. The successful candidate will have extensive experience in establishing key quality system metrics, strong interpersonal skills, and a proven track record of leading high-performance teams. The ability to communicate effectively and proactively, as well as being goal-oriented with a focus on continuous improvement, is essential. A proactive and solution-focused approach, as well as the ability to work with minimal supervision and influence others, are also key attributes for this role.

Hiring Manager Title
Senior Vice President, Quality Assurance

Travel Percent
Less than 10%

Functions

• CEO/President
• Non-Profit Management
• Operations
• General Management
• Strategy