Sr. Director of Manufacturing Quality Operations (ADX-203-20) at ArcherDX

| Greater Boulder Area
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Sr. Director of Manufacturing Quality Operations (ADX-203-20)
 
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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 Senior Director of Manufacturing Quality Operations, reporting to the VP of Quality Control and Manufacturing Engineering, will establish, oversee, and manage the Manufacturing Quality and Continuous Improvement programs. They will provide leadership to establish and maintain quality levels that meet and exceed customer expectations. The Director of Manufacturing Quality Operations will implement and maintain a statistical based quality system, develop and maintain manufacturing quality systems in compliance with US FDA Regulations and ISO 13485:2016 standards, and maintain supplier quality relationships. Function includes management and oversight over Purchasing and Manufacturing Quality Department; assurance that relevant procedures are managed and continuously reviewed and improved for compliance and operating efficiencies; ensures that Purchasing / Manufacturing QA department personnel are trained; ensures compliance to medical device and in vitro diagnostic regulations, relevant to the scope of department.
 
RESPONSIBILITIES:
 
Job performance will involve a variety of activities including:
  • Determine the overall quality and continuous improvement strategy for department, to align with ArcherDX's overall strategic plan.
  • Organize and oversee management of the Supplier and Manufacturing Quality department, approving plans and expenditures necessary to achieve objectives.
  • Build strong quality systems for determining the appropriate infrastructure and resources required for department to achieve business objectives.
  • Ensure internal processes and metrics are aligned to create highest product quality and competitive advantage.
  • Provide Supplier and Manufacturing Controls leadership throughout the product development process
  • Provide leadership and guidance to ensure proper interface of Supplier and Manufacturing Controls to marketing, business development, and product development
  • Implement and maintain the necessary programs to support the Corporate Quality Policy, the Quality System, and the CI initiatives, as they relate to Supplier and Manufacturing Controls.
  • Review and Approve Supplier Quality Agreements and the Approved Supplier List
  • Oversee investigations of Supplier and Manufacturing quality issues to insure timely closed loop corrective actions and reports as required.
  • Oversee the management of Nonconformance Reporting, Investigation and Disposition
  • Support supplier quality programs; conduct supplier audits as needed to meet objectives.
  • Partner with the Directors of Manufacturing and Supply Chain to create and direct programs to ensure the quality of the product.
  • 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 assists in creating development and training plans.
  • Oversee compliant Purchasing and Manufacturing Document management and retention
  • 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.
 
EXPERINCE:
  • Minimum of 18 years experience in Quality Assurance/Quality Control with 15 years in a leadership position.
  • Knowledge of cGMP/CFR/FDA regulations
  • Ability to ensure continued compliance with all FDA regulations, International experience a plus
  • Previous demonstration of director/managerial and administrative skills
  • Strong leadership and communication 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 communication and presentation skills
  • Self-starter
    • Driven to perform
    • Self-directed: needs little explicit direction
    • Able to organize, prioritize, and delegate tasks to efficiently move projects forward. is
 
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

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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