FierceBiotech and FiercePharma Jobs
Manager/Associate Director Clinical Quality Assurance - Ultimate Solutions, Inc.
Jun 19
Location: Westchester County, New YorkCategories: Pharmaceutical
Website: http://www.ultimatesolutions.com
Position Description
Our client is a pharmaceutical company and is seeking with a Manager of Good Clinical Practice/Quality Assurance or an Associate Director of GCP/Quality Assurance. In this role, the individual will manage all GCP regulated Quality Assurance activities. This Manager/Associate Director will be responsible for performing international and domestic audits and provide corrective action recommendations. He/She will develop and oversee quality policies and audit plans for each Study and will work with the Executive Director or Quality Assurance to align Standard Operating Procedures with the company’s Quality Management System.
Responsibilities
Plan and conduct GCP Audits of Clinical Research activities; Primary responsiblity for conduct of US and Canadian Clinical Investigator sites.
Audit and evaluate all Vendors.
Ensure alignment and compliance with the company’s Quality Managememtn System.
Handle issues with GCP Audits.
Write Audit Observations.
Manage all Quality Assurance Vendors.
Assist with GCP training.
Participate in international CQA meetings.
Experience
Bachelors Degree in a Scientific or Health Related field with at least six years of pharmaceutical industry experience and at least four years of auditing experience within the pharmaceutical industry.
Or Advanced Degree with at least four years of pharmaceutical industry experience and four years of auditing experience.
Excellent interpersonal and communication/written skills; Open mind and flexible attituide
Ability to review documentation, processes and procedures as they relate to Clinical Trial Activities
Desire to cross-train in other GCP/QA areas.
In return for your expertise, our client offers an outstanding salary/bonus package along with excellent benefits and an exciting working environment. Interested/Qualified candidates, please send your complete resume/CV in MS Word format to jobs@ultimatesolutions.com or call (201) 291-2880.
