Job Summary
The role involves leading the Quality functions at the US facility, directing strategies, ensuring compliance, preparing for inspections, and governing site operations. This position entails harmonizing local efforts with broader global Quality goals and enhancing business expansion through effective Quality management related to client support and service growth.
Responsibilities
- Oversee Quality functions and strategy at the facility level.
- Ensure compliance with regulatory standards and readiness for inspections.
- Align local Quality initiatives with global objectives.
- Provide leadership in Quality for client implementations and service expansions.
- Enhance operational capabilities through effective Quality management.
Qualifications
- Minimum of 10 years of experience in Quality within pharmaceutical, biotechnology, or clinical supply settings.
- At least 5 years in a leadership role.
- A degree in Life Sciences, Pharmacy, Chemistry, or a related field is strongly preferred.
- Experience with audits and inspections, Quality Systems and Operations.
- Familiarity with relevant regulations and clinical supply chain procedures.
Clinigen provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
