Sr. Manager, Quality Assurance
Looking to accelerate your career with a fast-growing start-up pharmaceutical company? A leading pharmaceutical company is seeking an Sr. Manager, Quality Assurance to join its rapidly expanding team! With plans to develop combination products to use in conjunction with their proprietary small molecules the next Sr. Manager, Quality Assurance will need experience with combo products, or medical devices.
The Sr. Manager, Quality Assurance will have the following responsibilities:
Independently plans and conducts routine document audits. Quality findings will be presented to in-house client staff. Recommends CAPA for compliance concerns. Develops resolution of compliance concerns and reviews implementation of corrective actions.
Independently plans and conducts internal as well as external domestic and international audits/inspections. Presents findings to responsible individuals at contracted facilities. Recommends CAPA for compliance concerns. Reviews responses to audit findings independently.
Independently applies departmental SOPs and participates in the development of departmental SOPs, as appropriate. Reviews SOPs from departments outside Quality independently.
Accepts assignments to conduct additional special projects with minimal supervision and participation on various departmental committees, as required, to increase professional development. Communicates status to his/her management.
Independently tracks metrics and trends as well as compliance issues and their resolution on a periodic basis.
Participates on Process Improvement teams
The ideal candidate will have:
BA/BS in the life sciences and 6 years industry experience with 4 years auditing experience in the regulatory compliance environment or equivalent.
Advanced degree with 4 years of industry experience with 3 years of auditing experience in the regulatory compliance environment or equivalent.
Medical Device or Combination Product experience
GMP QA experience