Senior Manager, Quality Management Systems
Proclinical is currently recruiting for a Senior Quality Management Systems (QMS) Manager for a pharmaceutical company located in Philadelphia, PA. Successful candidate will oversee and actively participate in all aspects pertaining to Deviations, Investigations, Complaints, and CAPA. QMS must be able to thoroughly and accurately complete/assist in the investigation of incidents/events which have occurred during the manufacturing, packaging, testing and storage of pharmaceutical products for determination of root cause and product impact per FDA regulations. In addition, candidate will ensure that corrective and preventive actions (CAPA) based on investigation findings are identified and implemented to prevent occurrence/reoccurrence of the events.
- Review and/or conduct thorough investigations and act as the Investigation Team Lead for Incidents/Deviations, OOS Investigations, Laboratory Events and Product Complaint Investigations as required following appropriate company procedures.
- Ensure all investigations are completed in a timely manner to support product release and regulatory compliance
- Ensure that all Incidents/Deviations, OOSs, Laboratory Events and Product Complaints are documented and tracked according to procedures.
- Identify and oversee the implementation of the appropriate corrective and preventive actions (CAPA) to prevent occurrence/reoccurrence.
- Provide guidance to other departments and serve as subject matter expert (SME) on the performance of investigations and in the use of Root Cause Analysis Tools
- Manage CAPAs to ensure timely closure of actions resulting from various types of investigations.
- Provide training on conducting investigations and performing root cause analysis as needed.
- Assist during regulatory inspections or other audits, as required
- Initiate SOP revisions as needed to assure compliance and continuous improvement.
- Generate and facilitate changes to SOPs, policies, training materials, and other documents.
- Assist with training of new and current employees on Quality and Compliance related subject matter and participate in department or company projects/initiatives as requested.
- Interact with any and all other departments to resolve any issues regarding QMS documents
Skills and Requirements:
- Bachelor's degree; Degree in Chemistry, Biology or related science is preferred.
- Minimum of five (5) years of experience working in a GMP environment.
- Minimum of five (5) years of experience in a Quality role in a pharmaceutical manufacturing environment.
- Lean, Six Sigma and cGMP experience 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 call Brandy Plumb at (+1) 646-367-2745 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.