Manager of Quality, Diagnostics (GMP, CLIA) – NC Biotech/Will Relo

Job Type: 
Life Sciences
Clinical Research and Development
Quality Assurance and Quality Control
Scientific Research and Lab Operations
Other Life Science Positions
Data Management, Biostatistics and Programming
Employment Category: 
Direct Hire

Our client, a Research Triangle Park, NC biotech that is developing cutting-edge genomic amplification technologies, is expanding its team, and actively recruiting for an exceedingly sharp, knowledgeable and can-do candidate to drive all Quality functions. 

This is a critical role for the company, and compensation will be generous (including significant equity offerings and relo support). Finding the right candidate is a top priority at this time.

Key Things to Note:

  • This company is bringing new solutions for cellular heterogeneity in both the research and clinical studies space.
  • It manufactures commercially-available kits that contain the enzymes and reagents needed for scalable whole genome amplification as well as offers lab services for genomic analysis. Ideal candidate will bring Quality expertise for both product and service.  CLIA operations would be valuable.
  • This is a start-up setting.  This Manager, in conjunction with the COO and consultants, will develop Quality practices and systems for the entire organization.  We seek a candidate who will thrive in this building environment. Experience with new product introductions highly preferred.
  • This position will begin as a hands-on, individual contributor - with high growth potential.  We seek a Subject Matter Expert with a strong tactical and strategic mindset and work style.
  • This position is on-site at the company’s offices in Research Triangle Park, NC. Relo support will be provided.

The focus of the role will be to establish and implement rigorous and appropriate Quality Systems for the design and manufacture of novel genome amplification applications.

Selected Responsibilities:

  • Provide support to the R&D and manufacturing teams for the validation planning and transfer activities. Assist teams in determining validation needs and requirements.
  • Provide Quality Support to engineering change controls, deviation management, and document change management.
  • Drive the development and implementation of a Quality Management System.
  • Establish and maintain a process that ensures adequacy of complaint, non-conformance, and Corrective and Preventative Actions (CAPA) records, investigations, and corrective/preventative actions.
  • Provide Quality Support in the assessment and qualification of new suppliers and materials including specifications and inspection standards.
  • Conduct Quality audits of contract manufacturing partners and suppliers to insure the highest level of product.
  • Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders.
  • Establish a dashboard with the appropriate KPI’s.  Trend, analyze, and report on Quality data in order to improve product and process; develop recommendations based on data analysis.
  • Develop and execute strategies to close quality gaps in an efficient, technical, and compliant manner.

Targeted candidate will offer a BS/MS scientific degree and 7+ years of Quality Assurance experience in a life sciences or medical device setting.  CLIA experience preferred.  GMP experience required.

Other priorities include:

  • Experience building Quality programs in a start-up setting
  • Experience with new product introductions
  • Outstanding project management skills
  • Experience applying quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, IEC62304, GAMP5, IVDD, ISPE Baseline Guides, IVDR, MDSAP, and ASTM E2500-07 Verification Guideline)
  • Practical experience in design controls, risk management, validation, change control, and supplier quality
  • Experience with CAPA and failure investigation tools and techniques
  • Experience with CLIA Certification
  • Record of impact and growth

Finally, we seek an industrious and self-directed candidate who will be a significant contributor to this company that is doing innovative work in a critically-important field; A candidate who can thrive without a roadmap and will bring the knowledge, savvy and drive to work through ambiguity and complexity to achieve desired results.

This is an immediate need.  Please forward Word resume for prompt consideration.  Local candidates targeted.