The Manager of Research Quality Assurance is responsible for the quality oversight of Analytical Development activities. Oversight includes providing direction and guidance to the Analytical Sciences group regarding quality related issues and working within the quality systems to review and approve Analytical Sciences laboratory and GMP investigations, protocols, Specifications, Test Methods, and SOP's. In addition, the manager approves regulatory submission documents, site transfer documents, and new product documents, including IND and NDA CMC submissions. This role is also responsible for the development and maintenance of departmental SOP's and processes as assigned. As part of continuous improvement, the Manager RQA will initiate Quality System process improvements via the initiation of new processes or the improvement of existing processes.
PRINCIPAL ACCOUNTABILITIES:Specific responsibilities include:
- Manage Quality Systems such as Deviation Management, Laboratory Investigations, Planned Deviations, CAPA, Stability, Specifications, Laboratory Equipment Qualification/Calibration and Reference Standard management.
- Monitor assigned Quality Systems, generating metrics and presenting metrics and system risks to management on a periodic basis
- Provide direction and guidance to the Analytical Sciences group regarding quality related issues
- Review and approve documentation such as investigations, methods, method validations, planned deviations, CAPAs, Certificates of Analysis
- Review and approve Change Controls
- Review and approval of Method Validation Protocols and Reports
- Review and approve equipment qualification protocols and reports and oversight of the calibration program
- Verify source data and review of IND/NDA CMC sections for regulatory filings
- Assess analytical lab notebooks and data which requires an understanding of chromatographic data, analytical lab troubleshooting, and the ability to evaluate laboratory conclusions for relevance to experimentation
- Oversee the Research Stability program
- Participate on Non-Clinical Development teams as assigned and provide direction and guidance regarding quality related issues
- Author of Standard Operating Procedures and conducting training
- Facilitate the Research Quality Assurance internal audit program and hosting internal corporate audits as assigned
A minimum of a BS in the physical sciences and a minimum of 5 years pharmaceutical related experience within Laboratory, Production, and/or Quality Management and/or Research QA.
Required Experience & Technical Requirements
- A thorough understanding of analytical laboratory quality systems and an excellent working knowledge of CGMP, DEA, ICH, and FDA regulations.
- Possess good technical writing skills to be used in evaluating documents and writing SOPs and other associated documentation.
- Possess a strong ability to resolve and communicate technical issues, and perform root cause analysis.
- Hands on experience in the following computer software programs: Windows, MS Word, Excel, Outlook, and PowerPoint.
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com . No hard copy resumes will be considered.
Purdue Pharma L.P. - 15 months ago