Quality Director (ADX0019-17)

Published:

Nov 29, 2017

Department:

Quality Assurance

Location:

Boulder, CO
Apply now

Position Summary

The Quality Director is a strategic position responsible for managing the development, administration and communication of Quality Assurance (QA) activities and implementation of the Quality Management System (QMS) procedures and programs to establish and ensure compliance with relevant ISO standards and FDA regulations.

Responsibilities

  • Lead the QA function to ensure quality system development, activities and programs related to product development and manufacturing activities such as maintaining ISO 13485 certification, compliance with cGMP, FDA and other relevant regulations
  • Subject matter expert for the evaluation, prioritization and communication of quality issues relevant to corporate goals including serving as Management Representative, providing regular reports to executive management for management review meetings and participating on project teams and/or working groups, as required
  • Support business-wide quality assurance by working with appropriate team members to develop and enforce policies and procedures
  • Delivery of strategic plans and written and verbal communication with regulatory agencies (US and global)
  • Manage Quality and Regulatory department personnel
  • Ensure delivery against Quality departmental goals and objectives through accurate planning of activities, budgets and resources
  • Develop, oversee and provide corporate quality training such as GMP training
  • Ensure the successful development, implementation and administration of a system for Quality documentation and controlled records including standard operation policies and procedures
  • Direct or oversee internal and external audits and inspections, draft audit reports and delivery on required actions
  • Manage maintenance of Quality Systems (deviations, non-conformance, corrective and preventative actions, document and supplier control, etc)
  • Perform other duties as assigned by supervisor

Key attributes

  • Integrity and adherence to ethical and regulatory standards, especially under pressure
  • Desire for quality with ability to integrate detailed RA/QA information into the corporate strategy
  • Excellent decision making skills including risk-based strategic prioritization
  • Strong time management skills (schedules, timelines, task prioritization) and the ability to adapt to changing priorities
  • Excellent multi-tasking and problem-solving skills; solution-oriented; self-motivated
  • Ability to interact with multiple disciplines and communicate clearly and effectively verbally and in writing
  • Soft skills required to:
    • successfully lead cross-functional teams to achieve goals
    • maintain positive stakeholder relationships and achieve goals within company and with clients, as needed
  • Desire to own decisions and take responsibility for outcomes
  • Willingness to embrace personal and professional development

Experience

  • College degree plus a minimum of 7 years' related experience such as Quality System or Quality Assurance manager, director, or equivalent, preferably in the medical device or pharmaceutical industries
  • Proven performance as related to FDA and ISO regulations
  • Minimum 5 years supervisory/managerial experience in quality assurance or regulatory compliance
  • In-depth knowledge of all quality system regulations including ISO, FDA inspections, client audits and/or ISO audits
  • Software QA experience a plus
  • Preferred knowledge and/or experience with basic molecular and biochemical methods

Education

  • Minimum requirement: BS
    • Preferred major/focus in molecular biology, biochemistry, chemistry or related field, and/or equivalent combination of education and experience
  • Regulatory (RAC) and/or Quality (ASQ) certifications and/or equivalent combination of education and experience
  • Project Management (PMI) certification desired

Company Description

ArcherDX, the NGS applications company, is developing and commercializing a novel approach to target enrichment chemistry. Next-generation sequencing technology based on Anchored Multiplexed PCR (AMP™) generates a highly enriched library of gene targets of interest for downstream genomic sequencing. Complemented by proprietary software and readily accessible reports, our technology enables dramatic enhancement in mutation detection speed as well as complex mutation identification and discovery.

Unless otherwise stated, all descriptions above are preferred but not required for our ideal candidate. Consideration will be given for comparable experience. ArcherDX is an Equal Opportunity Employer.

We offer competitive compensation and generous benefits programs. E-mail your résumé in confidence with salary requirements to careers@archerdx.com.


    Apply now   

Principals only. Recruiters, please do not contact this job poster

How to contact us

Address

2477 55th Street, Suite 202

Boulder, CO 80301

Phone

Phone: (877) 771 1093

Phone: (303) 357 9001

All content © 2017 ArcherDX, Inc.

For Research Use Only. Not for use in diagnostic procedures. For Research Use Only. Not for use in diagnostic procedures.