Our client, a growing biopharmaceutical company is seeking a GMP Quality Assurance Manager to join their team in Delaware, USA. The company develops therapies for various diseases including cancer and arthritis.
This position is responsible for supporting GMP Quality Assurance (QA) in maintaining the company's Quality Systems related to clinical development, manufacture and testing of clinical supplies and commercial product. These include Quality System oversight for Metrics, Product Complaints, Batch Record, Change Control and Risk Management. The position will ensure the company's Quality Systems are maintained, including control over the documentation required for regulatory submissions. The QA Manager will have an excellent knowledge of Pharmaceutical GMPs Quality Systems and be capable of performing various QA functions.
- Develop, implement, perform and maintain Quality Systems and procedures for the QA, CMC, RA, and Clinical Development departments.
- Maintain and present applicable Quality System Metrics to Management.
- Accountable for entry of Quality Management System-related information into applicable logs, both manual and electronic.
- Track the routing of all controlled documents related to Quality Systems, including SOP's, Change Requests and CAPA's, assuring proper and timely review, approval and effective dating.
- Manage and track controlled document distributions to external CMO's
- Provide support and participate in regulatory agency inspections.
- Identify & Alert QA supervision of internal and external quality system issues.
- Manage Product Complaint Program life cycle (Receipt, Process/Investigation/Tracking & Closure) including internal and external communications. Conduct, review and/or approve investigations.
- Provide training when needed on the Quality Management System.
- Perform and Participate in internal and external cGxP audits as required.
- Manage new and ongoing CMO Quality relationships as required.
- Review cGMP documentation, including, but not limited to master and executed batch records related to drug product, drug substance manufacture, packaging and labeling.
- Disposition of drug substance, drug product and packaging of supplies for clinical and commercial use.
- Support cross functional GxP audits and activities as required.
- Ensure timely routing and processing of all GxP documents.
- Work under challenging deadlines and be accountable for completing work within specified time periods.
- Other duties as assigned by management.
- Bachelors degree in scientific/life-sciences or related field.
- A minimum of 3-5 years of experience in the Pharmaceutical or Biopharmaceutical industry with at least 3 or more years of experience in an FDA quality/regulatory related function required.
- Thorough understanding of quality management systems and quality system practices in the pharmaceutical industry. Experienced with CMO relationship/Quality System management preferred.
- Demonstrated ability to effectively maintain and present Quality System Metrics.
- Experience with an EDMS, Training and Quality Management System. Strong detail orientation and focus on quality work product.
- Ability to manage and prioritize projects under tight deadlines.
- Strong written, oral communication, interpersonal, and organization skills.
- Strong computer skills including knowledge and experience using Microsoft applications including Excel, Word, and PowerPoint.
- Ability to travel 15%.
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 Matt Tong on +1 646 768 9726 or upload your CV 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.