Job Summary
The role involves leading and enhancing the quality management systems and ensuring regulatory compliance within manufacturing environments that are subject to regulations, such as medical device, pharmaceutical, and food production sectors. This position also entails overseeing quality personnel, managing audits, facilitating product releases, conducting validations, handling investigations, and overseeing quality activities with customers and suppliers, as well as maintaining cleanroom operations and electronic Quality Management Systems (eQMS).
Responsibilities
- Lead the improvement of site quality management systems.
- Ensure adherence to regulatory compliance in manufacturing operations.
- Manage a team of quality staff and oversee their performance.
- Conduct and manage internal and external audits.
- Coordinate product release processes and validations.
- Lead investigations related to quality issues.
- Manage quality interactions with customers and suppliers.
- Oversee cleanroom standards and eQMS controls.
Qualifications
- Bachelor’s degree in a technical or life sciences discipline.
- Minimum of five years of relevant professional experience with a focus on leadership.
- At least three years of experience in medical device or pharmaceutical quality assurance or regulatory affairs.
- Advanced training or experience with ISO 13485 and ISO 14971.
- Knowledge of FDA Quality System Regulation (QSR) is essential.
- Familiarity with auditing procedures and cleanroom operations.
- Experience in sterile production and USDA organic manufacturing is beneficial.
RR Donnelley 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.
