Director of Quality Assurance (ADX-236-19)

| Greater Boulder Area
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Director of Quality Assurance ADX-236-19 

 

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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 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 in compliance with US FDA Regulations and applicable FDA guidance documents, ISO 13485:2016, ISO 14971:2012 and other international standards. Functions include management, oversight and monitoring of CAPA, Complaints, Management Review, Document and Records Control, Training, and Internal Audit. Assure that relevant procedures are managed and continuously reviewed and improved for compliance and operating efficiencies.
 
RESPONSIBILITIES:
  • Determine the overall quality and continuous improvement strategy for department, to align with ArcherDX's overall strategic plan.
  • Organize, oversee and lead management of CAPA, Complaints, Management Review, Document and Records Control, Training and Internal Audit, approving plans and expenditures necessary to achieve objectives.
  • Build strong quality system infrastructure and resources required for department to achieve business objectives and scale with the organization.
  • Ensure internal processes and metrics are aligned to create highest product quality and competitive advantage.
  • Provide leadership and guidance to ensure proper interface between process components of the Quality System.
  • Implement and maintain the necessary programs to support the Corporate Quality Policy, the Quality System, and Continuous Improvement initiatives as they relate to the QMS.
  • Partner with the Director of Quality Manufacturing and Operations to ensure product quality.
  • Direct/Oversee internal and external audits and inspections, draft audit reports, and delivery on required actions
  • Provide training and leadership and represent a positive and enthusiastic role model to ensure high engagement across the team.
  • Coach team leaders on leadership development and assist in creating development and training plans.
  • Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
  • Safeguarding the privacy and security of protected health information and European Union personal data.
  • Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
  • Perform other duties as assigned by supervisor
 
QUALIFICATIONS:
  • Bachelor’s Degree required. Master’s Degree preferred
  • 10+ years’ in Quality System Leadership Role
  • Knowledge of cGMP/CFR/FDA regulations required
  • Previous Director and Administrative Level Skills
  • Strong Leadership and Communication Skills
  • Ability to ensure continued compliance with all relevant US and ex-US Regulations, guidance documents and consensus standards.
  • Preferred knowledge and/or experience with basic molecular and biochemical methods.
KEY ATTRIBUTES:
  • Integrity and adherence to ethical and regulatory standards
  • 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
EDUCATION:
  • Minimum requirement: BS
  • Quality (ASQ) certifications and/or equivalent combination of education and experience.
  • Project Management (PM) certification and/or Lean Six Sigma desired.
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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

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

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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