Director QA GCP (25% US travel)
Title of Position:
Director, Quality GCP
Vice President, Quality
US Quality Unit
FUNCTION OF POSITION: Quality
Directs and coordinates one- two GXP discipline(s). Responsible for independently performing domestic and international audits/inspections for client groups that ensure compliance to the FDA and other worldwide health authority regulations /guidelines, site SOPs, protocols, and industry standards, as applicable. This includes applying developed skills to assure management that the facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports, and/or controls are in conformance with applicable regulations. Provides recommendations for corrective action and tracks corrective action commitments until closure.
30% Directs and coordinates activities related to one - two GXP discipline(s). Manages day-to-day activities at local site level. Participates in departmental discussions/decisions pertaining to other GXP functions.
25% Independently plans and conducts routine document and/or internal audits. This may include project and internal audits. QA findings will be presented to in-house client staff and, if appropriate, to the responsible individuals at contract facilities. Recommends corrective action of compliance concerns. Develops resolution of compliance concerns and reviews implementation of corrective actions.
20% Plans and conducts domestic audits/inspections.
10% Independently applies departmental SOPs and participates in the development of departmental SOPs, as appropriate. Independently reviews SOPs from departments outside Quality.
5% Accepts assignments to independently conduct additional special projects and participates on various departmental committees, as required, to increase professional development. Communicates status to his/her management.
5% Track metrics and trends as well as compliance issues and their resolution on a periodic basis.
5% Participates on Process Improvement teams.
Continues to develop while applying established skills in one - two of the following GXP disciplines: Good Laboratory Practices (GLPs) applicable to nonclinical research and analytical support of clinical trials, B) Good Clinical Practices (GCPs) applicable to clinical research, (C) Good Manufacturing Practices applicable to clinical supplies or commercial manufacturing.
Participates as support during GXP compliance inspections conducted by external sources (i.e. regulatory agencies) and third parties, as applicable.
- BA/BS in the life sciences and 10 years industry experience with 8 years auditing experience in the regulatory compliance environment or equivalent. Minimum of 6 years managerial experience.
- Advanced degree with 8 years of industry experience with 7 years of auditing experience in the regulatory compliance environment or equivalent. Minimum of 6 years managerial experience.
- Computer skills and understanding are necessary.
- Ability to prioritize, schedule, and manage multiple activities and resources simultaneously.
- Excellent communication and interpersonal skills needed.
- Approximately 25% US based travel