Job Details

Vice President of Quality Assurance

About the Company

Globally-recognized provider of plasmid DNA & gene editing services

Industry
Biotechnology

Type
Privately Held, Private Equity-backed

Founded
1998

Employees
1001-5000

Specialties

• plasmid dna
• messenger rna (mrna)
• recombinant proteins
• crispr/cas9
• cgmp
• gmp-source
• gene therapy
• cell therapy
• vaccine development
• and gene editing

About the Role

The Company is seeking a VP of Quality Assurance to join their team. The successful candidate will be responsible for the creation, implementation, and maintenance of all quality and release processes in compliance with regulatory and statutory requirements. This role involves providing strategic direction and tactical leadership to ensure continuous improvement and supporting the company in maintaining positive audit results. The VP of Quality Assurance will also serve as the primary contact for quality and compliance issues with customers and regulatory agencies, and will be involved in the development and enhancement of quality management systems programs.

Applicants must have a minimum of 10 years' of relevant experience in a quality position, with at least 3 years' in a managerial role, and a Bachelor of Science degree. Experience in final drug product manufacturing, quality assurance, and regulatory audits is essential. The role requires a strong knowledge of GMPs and FDA and EU regulations related to the manufacture of biologics. The ideal candidate will have the ability to manage priorities, track project progress, and provide updates to leadership. Experience in a matrix environment and in implementing cGMP quality strategy is a plus. The VP of Quality Assurance will also be responsible for leading and managing a team, including supervision, performance management, and training.

Hiring Manager Title
VP of Quality

Travel Percent
Less than 10%

Functions

• General Management
• Operations
• Strategy