Quality Systems Manager (Gene Therapy Manufacturing) – Top Dollar/Raleigh
Our client, a rapidly-expanding biotechnology company that is building out its primary manufacturing facility in the North Raleigh area, is actively recruiting for a very knowledgeable and skilled Quality Systems Manager to assume key role on its Quality leadership team.
Key Things to Note:
- This is a global company that is developing immunotherapies for cancer treatment based on its patented gene editing technology. Although gene therapy bkgd would be desirable, client is open to candidates with cell therapy/biologics bkgds.
- This company is in start-up mode, preparing for 2021 production. Right candidate will be highly skilled at building Quality Systems programs “from scratch.”
- This QSM will be the point-person for all inspections and audits. Experience hosting FDA inspections and interfacing with regulatory authorities will be important.
- This QSM, together with the Head of Quality, will be responsible for developing the KPI system and the ongoing oversight and presentation of metrics. Seek candidate who is highly skilled in metrics analytics.
- Currently the company relies on paper systems. This Manager will drive the effort to research, select and implement its electronic document management systems. Familiarity with various EDMS systems and implementations will be important.
- This is a hands-on management role. Seek strategic, process improvement-oriented Manager who will lead the planning effort and handle tactical tasks. This Manager will supervise 2 engineers.
This Manager will develop, implement and manage an integrated Quality System program, in a collaborative and inclusive manner and Best Practices standard.
- Hires, develops, trains and evaluates Quality Systems personnel
- Hosts inspections at the production facility
- Owns the corporate electronic applications for managing elements of the Quality System (documentation/records management, change management, deviation/CAPA management, training)
- Ensures and promotes compliance with applicable US and European cGMP regulations, corporate policies and company Standard Operating Procedures
- Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies
- Maintains systems to track and trend key Quality System Indicators and ensure KPIs are addressed. Assures adverse trends or patterns are noted and are promptly addressed. Presents metrics to Quality Council.
Targeted candidate will offer a related degree and 5+ years of Quality Systems experience in the Life Sciences industry. Substantial familiarity with optimizing EDMS systems will be important. Other priorities include:
- Experience developing and managing Quality Systems in a GMP-compliant facility
- Demonstrated ability to independently (and effectively) host inspections
- Knowledge of current global initiatives including Quality by Design, Process Validation and Data Integrity
- Experience writing Quality Manuals, Policies, Standard Operating Procedures and Work Instructions
- Ability to adapt Quality System elements for pharma to cell/gene manufacturing
- Understanding of aseptic manufacturing
- Experience developing, managing, analyzing and reporting Quality KPIs/metrics
- Superb project management and project leadership skills
- Excellent judgment demonstrated by superb problem-solving and decision-making capabilities
- Longevity and impact in previous roles
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. Compensation will be generous.
Please forward Word resume from prompt consideration. Local candidates only.