Confidential
About the Company
Join an innovative and emerging biopharmaceutical company focused on advancing healthcare solutions.
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
Major Depressive Disorder (MDD)
Psychiatry
Depression
Neuropsychiatry
Tonic-Clonic Seizures
First-Order Statistics (FOS)
Post-Genomic Therapeutic Systems and Chemistry (PGTSC)
Sodium Channels
Potassium Channels
About the Role
We are seeking a driven and experienced Senior Executive for Quality Assurance specializing in GMP. As a pivotal member of the Quality leadership team and the R&D Operations group, you will oversee the implementation of quality program requirements across all clinical and commercial phases. This role is ideal for professionals with extensive experience in quality and manufacturing, particularly with small molecule products.
The Senior Executive will handle all quality-related matters at a Contract Manufacturing Organization (CMO), lead external quality initiatives, and collaborate with internal Chemistry, Manufacturing, and Controls (CMC) teams to maintain cGMP compliance. Strong leadership capabilities in high-stakes environments, exceptional communication skills with all levels of personnel and external partners, as well as a dedication to fostering a culture of quality throughout the organization, are essential for success.
Candidates should have a Bachelor’s degree in a life sciences discipline and a minimum of 12 years of leadership experience in GMP quality management. A solid grasp of small molecule manufacturing, particularly in solid oral dosage forms, along with global GxP standards, is imperative. This role includes representation of the Quality function in various meetings, overseeing quality system and product evaluations, and ensuring adherence to data integrity standards.
The ideal candidate will be results-driven, skilled at troubleshooting and problem resolution, and will advocate for continuous improvement within total quality management practices. You should possess strong interpersonal skills, the ability to inspire high-performance teams, and a proactive, solutions-oriented communication style. Additionally, you will manage budgets, engage in strategic planning, and may be involved in the recruitment and development of your direct reports.
Hiring Manager Title
Senior Vice President, Quality Assurance
Travel Percent
Less than 10%
Functions
CEO/President
Non-Profit Management