Sr. Manager, Quality Assurance - United States
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- This position is responsible for supporting GMP Quality Assurance (QA) in maintaining company's Quality Systems related to clinical development, manufacture and testing of clinical supplies and commercial product for large and small molecules.
- The position will ensure company's Quality Systems are maintained, including control over the documentation required for regulatory submissions.
- The QA Sr. Manager will have an excellent knowledge of Pharmaceutical GMPs and be capable of performing various QA functions.
- Develop, implement, perform and maintain our company's Quality Systems and procedures for the QA, CMC, RA, and Clinical Development departments.
- Act as a knowledge manager of our company's EDMS and Quality Management System.
- 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.
- 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.
- Assist with the notification, monitoring and closure of investigations and complaints related to clinical and commercial supplies.
- Support cross functional GxP audits and activities as required.
- Ensure timely routing and processing of all GxP documents.
- 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 our company's 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
- Conduct, Review and/or Approve deviations/investigations.
- Provide support and participate in regulatory agency inspections.
- Identify & Alert QA supervision of internal and external quality system issues.
- Will be immediate authorized department back-up for Director of QA.
- 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 5-7 years experience in the Pharmaceutical or Biopharmaceutical industry with at least 5 or more years 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.
- 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 15-20%.