Associate Director, Clinical Quality Assurance
A fast-growing biotech company is seeking an Associate Director Clinical Quality Assurance to join its rapidly expanding team! Now is the perfect time to get in with this group as you will be an integral member of the team responsible for the growth and leadership of the QA group. If you are looking for your next QA growth opportunities than don't hesitate to apply.
The Associate Director, Clinical Quality Assurance will have the following responsibilities:
- 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.
- Plans and conducts domestic and international audits/inspections independently.
- Independently applies departmental SOPs and participates in the development of departmental SOPs, as appropriate. Independently reviews SOPs from departments outside QA.
- Accepts assignments to conduct additional special projects with minimal supervision and participates on various departmental committees, as required, to increase professional development. Communicates status to his/her management.
- Track metrics, with minimal supervision, 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 8 years industry experience with 6 years auditing experience in the regulatory compliance environment or equivalent.
- Will also consider advanced degree with 6 years of industry experience with 5 years of auditing experience in the regulatory compliance environment or equivalent.
- 4 years management experience.