Radius Health, Inc. is seeking a GMP Quality Assurance Manager with experience in supporting GMP operations and compliance for solid dosage and/or drug/device combination products in accord with FDA CFR Part 4, 210 and 211, FDA 21 CFR Part 820, EU GMP Volume 4, ISO 13485, ISO 14971, ICH Q7, Q8, Q9 and Q10; performing in a fast-paced environment under tight deadlines.
The incumbent will have responsibility to ensure that all quality management functions are maintained according to GMP requirements. The incumbent will execute Quality Assurance and quality system activities with a focus on Radius’ late-phase development and commercial products, ensuring consistent application of cGMPs. Specifically, s/he will have responsibilities for execution of quality systems related to complaint management, complaint investigations, CAPA and deviation management and change management.
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.