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

| Greater Boulder Area
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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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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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