About this role
Duties & Responsibilities
- Performs internal and third-party audits.
- Supports regulatory inspections and client audits. Manages and improves audit program.
- Provides direction on audit operational activities and the development of audit responses, CAPA plans, and Effectiveness Checks.
- Oversees company’s supplier quality program including supplier qualification and audit (some travel required)
- Assists in the oversight, facilitation, and implementation of continuous improvement of the company’s quality systems
- Administers the quality risk management program and conducts risk assessments
- Document authorship, review, and approval of SOPs, reports, and quality records.
Required Skills & Abilities
- Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211).
- Knowledge of GMP, FDA, and EMA expectations for clinical trial and commercial materials, manufacturing, and testing
- Excellent verbal and written communication skills
- Excellent time management skills with a proven ability to meet deadlines
- Excellent organizational skills and attention to detail
- Demonstrated ability to collaborate and work in cross-functional teams
- Scientific curiosity and willingness to learn
- Strong analytical and problem-solving skills
- Ability to prioritize tasks and to delegate them when appropriate
Education & Experience
- Minimum of a Bachelor's Degree, preferably in a scientific discipline
- 8+ years previous quality assurance experience including Auditing and Supplier Quality experience
- Working knowledge of Veeva preferred
Physical Requirements
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 15 pounds