Senior Quality Compliance Specialist
Proclinical is currently recruiting for a Senior Quality Compliance Specialist with a biopharmaceutical company located in North Chicago, IL.
- Primarily responsible for developing, negotiating and writing new and revised quality agreements and supporting agreements for R&D
- Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures
- R&D Quality Agreement liaison with Operations including negotiating / writing R&D elements for shared R&D / Operations Quality Agreements and associated documents
- Manage Quality Agreement life cycle; lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Quality Agreements, as applicable
- Manage processes for the timely QA writing / review / approval of Quality Agreement related policies, processes, procedures, templates and other documentation
- Collect, analyze and report metrics pertaining to GxP Compliance
- Support audit activities with respect to Quality Agreements and other Quality System elements including audit preparation, responding to audit requests, subject matter expert resource
- Effectively communicate audit results, both orally and in writing.
- Review corrective action plans / audit responses for adequacy and approve if adequate
- Review/edit GxP Service Provider business contracts/agreements and related documents for Quality related subject matter to ensure compliance with current regulations/guidance/industry standards and Quality System requirements.
Skills and Qualifications:
- Bachelor's degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required
- 7+ years of experience in Quality Assurance, Regulatory Affairs and/or Clinical Research Development/ Manufacturing
- Pharmaceutical experience is preferred
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Amanda Rivera at 267-435-8555 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.