Vice President, Quality (ADX-34-21) at ArcherDX

| Greater Boulder Area
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Vice President, Quality (ADX-34-21)

 

COMPANY SUMMARY:

 

In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.

 

POSITION SUMMARY:

 

The VP of Quality, reporting to the Chief of Diagnostic Strategy, will establish, oversee, and manage Software and Design Quality, Manufacturing Quality Operations and Quality Systems, and be a key cross functional leader supporting continuous improvement programs. The VP of Quality will implement and maintain a statistical based quality system, develop and maintain quality systems in compliance with US FDA Regulations and ISO 13485:2016 standards, and maintain supplier quality relationships. They will provide leadership to establish and maintain quality levels that meet and exceed customer expectations. 

 

RESPONSIBILITIES:

 

Job performance will involve a variety of activities including:

  • Determine the overall quality strategy for the Oncology division, to align with ArcherDX's overall strategic plan.
  • Represent the Quality organization to executive management and other leadership forums with competence, professionalism, and strategic vision. 
  • Build strong quality systems for determining the appropriate infrastructure and resources required for each sub-department to achieve business objectives.
  • Define and champion a Quality Policy which enables continuous improvement, compliance to relevant quality standards and regulations, and enables efficient fulfillment of ArcherDX’s mission and initiatives. 
  • Oversee all quality assurance activities, including planning, coordination, and implementation efforts for compliance with all cGMPs, regulations, laws and internal SOPs and WIs through audit, inspection and training of personnel. 
  • Ensure internal processes and metrics are aligned to manufacture/design the highest product quality and competitive advantage.
  • Accountable for implementing and maintaining the necessary programs to support the Corporate Quality Policy, the Quality System, and the CI initiatives.
  • Represent ArcherDx in discussions, inspections, and other audiences with regulatory authorities.
  • Provide training, leadership, and represent a positive and enthusiastic role model to ensure high engagement across the team.
  • Coach team leaders on leadership development and assists in creating development and training plans.
  • Perform other duties as assigned by supervisor
  • 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.

 

EXPERIENCE:

  • Minimum of 15 year’s experience in Quality Assurance/Quality Control, with at least 7 years in a leadership position.
  • Minimum of 10 years experience in the medical device industry, with at least 5 year of experience in IVD devices specifically. 
  • Strong knowledge of 21 CFR 820 and ISO 13485:2016 to ensure compliance with all FDA regulations; international experience a plus
  • Working knowledge of global regulatory submissions and typical content included therein
  • Direct experience being interviewed in inspections and audits, and familiarity with audit support practices 
  • Previous demonstration of Director level leadership skills 

 

KEY ATTRIBUTES:

  • Drive and determination
  • Ability to work in a fast paced and dynamic environment
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
  • Strong leadership and communication skills
  • Self-starter
  • Driven to perform
  • Self-directed: needs little explicit direction
  • Able to organize, prioritize, and delegate tasks to efficiently move projects forward

 

EDUCATION:

  • Bachelor's degree required. Master’s Degree preferred.

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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

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 sync
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
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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