The Director of Quality will be accountable for the continuous development, execution and administration of a comprehensive GxP Quality System that meets all compliance requirements pertaining to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), ICH, FDA and EMA regulations. This position will establish, maintain, and continually improve the Quality Management System and related Quality Operations and Quality Assurance. The Director will also provide overall Quality and Compliance oversight for process development and manufacturing, nonclinical, and clinical processes.
- Establish and maintain phase appropriate GMP compliance for product manufacturing, testing, and stability.
- Manage Quality Assurance relationships with GMP service providers; work with CMO QA and technical teams to assess and resolve discrepancies, and noncompliance events to ensure the quality of the product through performance of thorough investigations and risk assessments.
- Review and edit Quality Agreements, contracts, supply agreements, etc., provide quality input to project/program plans, master service agreements and statements of work.
- Implement GCP Quality Assurance programs for clinical trials execution and reporting.
- Quality management of CMOs, CROs, contract test laboratories and other vendor services.
- Ensure robust planning and execution of documentation for all regulated work and Regulatory submission-supporting activities, both internal and external (CRO, CMO).
- Develop and implement Quality Systems to support Dova’s growth.
- Manage audit program against GxP standards, FDA/EMA/ICH requirements, and other regulatory standards and ensure timely resolution of any identified issues.
- Establish and manage a comprehensive internal compliance training program.
- Work cross functionally, representing the Quality group on discovery and development teams, line functions and to senior management for awareness of and compliance with quality/regulatory requirements.
- Develop solutions to complex quality issues and work closely with senior management to prevent and resolve significant compliance issues.
- Proven track record of creating, establishing and maintaining strategically focused Quality functions.
- Bachelor’s degree in a scientific discipline.
- Minimum 15 years of experience in Quality Assurance with at least 10 years of experience in GMP pharmaceutical development, manufacturing and testing as well as experience in Clinical and Commercial product development.
- Technical knowledge of analytical method qualification, process validation and establishing product specifications.
- Experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections.
- Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts.
Why Join Us?
With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. At our Durham office, we provide a sleek and high-tech work environment with glass walls and adjustable desks. All employees are issued laptops, have access to a stocked kitchen, and are included in Free Lunch Fridays! We also offer a competitive benefits package, to support the health and happiness of our staff.
An Equal Opportunity Employer
Dova is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Dova are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.