Director of Quality Analytical Services (ADX-114-20)

| Greater Boulder Area | Hybrid
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Director of Quality Analytical Services (ADX-114-20)

 

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THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

 

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

 

POSITION SUMMARY:

 

The Associate Director of Quality Analytics will establish, oversee and manage the quality analytical services function in compliance with appropriate regulations such as GMP (good manufacturing practice), GLP (good laboratory practice), and GCP (good clinical proactive). Areas of direct ownership will include quality control testing, test method validation, stability program and laboratory management. This role shall provide strategic leadership to establish and maintain quality levels that consistently deliver best-in-class products that comply with US FDA Regulations and ISO 13485:2016. Function includes direct, solid-line management and oversight for Quality Control teams.

 

RESPONSIBILITIES:

  • Determine the overall quality and continuous improvement strategy for Quality Analytics to enable ArcherDX's overall strategic plan, Corporate Quality Policy, Quality System objectives, and the continuous improvement initiatives
  • Organize and oversee management of the Quality Control and Test Method Validation teams, approving plans and expenditures necessary to deliver on key initiatives
  • Foster a strong quality systems culture within the Quality Analytics function
  • Ensure appropriate organizational infrastructure and resourcing for the Quality Analytics team to achieve business objectives
  • Provide strategic analytical leadership throughout the product development process and ensure strong quality domain representation in product development and manufacturing services teams
  • In conjunction with cross functional leaderships develop appropriate metrics, and tools for data collation.
  • Oversee investigations of laboratory issues to insure timely, closed loop corrective actions and reports as required
  • Lead by example to create an inclusive culture that values high engagement within the Quality Analytics team
  • Build a highly coalesced, results driven Quality Analytics team with a robust bench of future leaders

 

KEY ATTRIBUTES:

  • Passion for enhancing healthcare outcomes with novel technology
  • Problem solver comfortable operating in the grey-space and driving forward with risk balanced decision making
  • Must exemplify Archer’s values: Accountability, Care, Trust, Grit & Urgency
  • History of thriving in a fast-paced, dynamic environment
  • Inspirational people leader with a history of managing teams to deliver their best work
  • Self-starter
    • Driven to perform
    • Self-directed: needs little explicit direction
    • Able to organize, prioritize, and delegate tasks to efficiently
  • Strong leadership and communication skills

 

EXPERIENCE:

  • Associate Director: Minimum of 10 years experience including quality and laboratory experience, with a minimum of 5 years in a leadership position
  • Knowledge of genetics, familiarity with genomic data, proficiency in molecular techniques, NGS strongly preferred
  • Working knowledge of cGMP/CFR/FDA regulations
  • Experience with applicable FDA regulations and ISO standards, working knowledge of international regulations strongly preferred

 

EDUCATION:

  • Bachelor's degree required; Advanced Degree preferred
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Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

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