Manager, Quality Control

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Summary

The Manager of Quality Control will be responsible for scheduling testing and training QC analysts on appropriate test methods, identifying third-party laboratories, and outsourcing various testing. He or she will provide tactical leadership and management of the quality control function, partnering with cross-functional disciplines to ensure a harmonized quality approach across all operations in the QC org, including incoming materials, release testing and environmental monitoring. He or she will act as the liaison and subject matter expert to advise internal teams and clients regarding quality control.

Key Areas of Focus

  • Uses Vernal’s quality systems and programs to promote high-quality standards and continuous quality improvement
  • Plan, lead, and manage quality control function as well as partnering with cross-functional leaders for QC testing support
  • Translates regulations, requirements, and guidelines into Vernal policy and ensures compliance in Quality Control
  • Provides guidance and counsel regarding identified Vernal quality control topics (e.g., deviations, change controls, and corrective and preventative actions)
  • Ensures compliance with FDA GLP and Good Manufacturing Practices (GMP), EU, and ICH guidelines and regulations and leads as SME to cross-functional groups within Vernal
  • Responsible for day-to-day quality control oversight of activities, related to incoming materials, drug substance and drug product manufacturing batch release, and environmental monitoring trends. 
  • Provides front-room or back-room support for health authority inspections and customer audits
  • Ensures QC documentation is compliant with Vernal SOPs, test methods and protocols
  • Reviews Vernal’s SOPs to ensure appropriate codification of GLP/GMP procedures relating to product quality and environmental monitoring
  • Responsible for training program including on-the-job training release testing and environmental monitoring
  • Application of the risk-based approach to quality with respect to phase-appropriate guidelines for pre-clinical and CGMP manufacturing.

Essential Responsibilities

  • Sponsor and execute corporate quality policy, mission, and vision.
  • Provide QC expertise on cross-functional team projects
  • Develop and provide ongoing leadership and support for the implementation of quality focus – company-wide
  • Continually assess the level of quality understanding throughout the company and provide appropriate quality education as appropriate
  • Assist with the development, documentation, communication, implementation, measurement, and continuous improvement of the systems that make up the overall Vernal Quality System
  • Ensure the Vernal Quality System follows applicable federal, state, local, and customer quality requirements (signed TQA)
  • Represent the Quality Control organization in internal leadership discussions and strategic planning as well as with customers, suppliers, and the professional community.
  • Mentor team members and partner with other leaders to establish a collaborative and transparent quality culture.

Professional Experience & Qualifications

  • PhD, Master’s degree in a scientific or related discipline or equivalent experience required. 
  • 5-10 years in quality control and at least 3-5 years of management experience required. 
  • Technical expertise in qPCR, Next Generations Sequencing (NGS), Liquid Chromatography/ Mass Spectrometry (LC-MS), and assay development work.
  • GLP/GMP experience in a biotech, pharmaceutical, or clinical research organization
  • Demonstrated ability to develop, lead and participate in cross-functional teams.
  • Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
  • Demonstrated ability to problem-solve.
  • Experience in designing, implementing, monitoring, and improving corporate-wide quality systems.
  • Proven success in integrating quality through the company through developing relationships and influencing functional corporate leaders.
  • Knowledge of GCP, GLP, ICH guidelines, FDA CGMP guidelines, and other applicable regulatory requirements.
  • Excellent organizational, verbal, and written communication skills. 
  • Represent the Quality organization in internal leadership discussions and strategic planning as well as with customers, suppliers, and the professional community.
  • Mentor team members and partner with other leaders to establish a collaborative and transparent quality culture.

How to Apply

If you feel that you are a great match for this position and want to make a difference in the exciting field of next-generation therapeutics, then reach out to us at [email protected] and be sure to include your resume and cover letter and “Executive Assistant/Office Manager” in the subject line. We look forward to hearing from you!

Diversity/Equal Opportunity Statement

Vernal is an equal opportunity employer. We recognize the value of diverse, multifaceted approaches towards innovation and aim to incorporate diverse perspectives and experiences. We strive to build a safe, welcoming, and inclusive work culture. 

About Vernal

At Vernal, you will offer knowledge-based solutions to help us address the growing demand for mRNA, lipid nanoparticle (LNP) mRNA, drug screening, and ultimately clinical supply of mRNA.  Together, we will create the most integrated solution for mRNA vaccines and therapeutic R&D.  Vernal will become the only one-stop-shop for our clients’ and partners’ mRNA needs, from concept all the way to clinical trials.  The mRNA research associate or scientist will develop methods to synthesize, purify, and scale up mRNA.  As a startup, we are seeking adaptable, creative thinkers who can independently foresee gaps and opportunities and who take the initiative to solve problems with a sense of urgency.  We expect the work to be rewarding, fast-paced, and to offer ample opportunities to plan and create new solutions to help grow our business.  Vernal will pay a competitive salary with generous benefits including health, dental, and vision insurance.  Although hiring level will depend on experience, we expect to grow with our employees and are interested in a variety of backgrounds.

Vernal Biosciences is located in Colchester, Vermont, adjacent to Burlington which is home of the University of Vermont and the UVM Medical Center.  Check out https://www.helloburlingtonvt.com/ for more information. The Burlington area, set on the shores of Lake Champlain, features the best of two worlds:

  1. Multicultural hub with great schools, restaurants, breweries, shopping, arts, and an affordable cost of living
  2. Gateway to the Green Mountains including world class hiking, camping, bicycling, and alpine and Nordic skiing

Please contact [email protected] with CVs or for more information