Manager/Sr Manager, Quality Systems (Documents/Records Mgmt) – Pharma/Top Dollar
Our client, a clinical stage RTP pharmaceutical firm with several late stage products in development, is actively recruiting for a very knowledgeable and skilled Quality Systems Manager, with particular strength in Records and Documents Management, to assume key role on its Quality Systems team.
This company is growing rapidly, and the document management systems need to be modified and enhanced to meet the needs of the future. This Manager/Senior Manager (client is open to both levels) will be instrumental in designing and developing these systems.
Client will pay top dollar to attract and retain a star.
Key Things to Note:
· The RTP office will be the hub for all Records Management activities, and will collaborate with three other US offices (primarily East Coast) on document management tasks. Right candidate will be effective at developing cooperative relationships with remote offices/employees.
- Currently the company uses several systems, varying by department and/or location, to manage documents and records. The goal, in preparation for future growth, will be to consolidate all records into one clean, accessible and compliant system. This Manager will drive that effort. Familiarity with various EDMS systems will be important.
- The company engages CMOs and external labs for many development and commercial activities. Experience overseeing Quality Systems in an outsourced environment, particularly as it relates to Records Management, will be important.
· This is a hands-on management role. Seek strategic, process improvement-oriented Manager who will lead the planning effort, while also handling all tactical tasks.
· Initial focus of this role will be Records and Documents. Over time, this candidate will take on other Quality Systems responsibilities. Seek curious and motivated candidate who will enjoy growing the role.
Role will involve driving the document management/control systems from designing, implementing, maintaining and training others on the “filing” strategy to overseeing the routing of documents for proper signatures, compliance, etc. to retention, retrieval, archival tasks. We seek a candidate who “has done” and “can do” it all.
- Manage, or assist in management and continuous improvement of company’s Quality Systems including:
- GXP Training
- Document Control & Records Management
- Quality Events
- Corrective and Preventive Actions (CAPA)
- Change Management and Product Complaints,
- Supplier Qualification Program
This will include documentation, audits, and quality agreements, Field Alerts, Stock Recoveries and Product Recalls, Risk Management Program, and Quality Management Review
- With Director of Quality Systems, prepare and modify as needed Standard Operating Procedures (SOPs). Ensure proper understanding (and compliance) amongst user community.
- Act as system administrator for systems owned by Quality (TrackWise, DocuSign, LMS) including:
- Requirement definition
- System design, development, and configuration
- Validation testing
- Author supporting documentation and system procedures
- Training and implementation
- End-user support and change management
- Champion continuous improvement of quality and compliance philosophy and practices to ensure the highest standards are maintained
- Assist in management of compliance issues with external suppliers, including CMO, CTLs and CROs
Selected candidate will offer a related degree and 5+ years of Document Management work in the Life Sciences industry. Substantial familiarity with industry Best Practices, including EDMS systems, will be important.
Other priorities include:
- Superb project management and project leadership skills
- Superb communication skills including the demonstrated ability to garner the cooperation and respect of a broad constituency of stakeholders
- Demonstrated ability to develop, implement and maintain quality systems and standards ensuring the Company is in compliance with GxP and global (both US and ex-US) regulations
- Experience working with CMOs and commercial supply chains for pharmaceutical products
- Excellent judgment demonstrated by superb problem-solving and decision-making capabilities
- Proficiency using MS Office software Excel, Word, PowerPoint
This is a dynamic, empowered, collaborative and mission-driven setting. In addition to technical requirements noted above, we seek a smart, self-directed and extremely reliable candidate who will thrive in a collaborative, empowered and mission-driven setting.
This is an immediate need and a critical need. Please forward Word resume from prompt consideration. Local candidates only.