Associate Director, Manufacturing Quality Operations

| Greater Boulder Area
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Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.

POSITION SUMMARY:

The Associate Director / Director of Quality Manufacturing and 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 Associate Director / Director of Quality Manufacturing and 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 Manufacturing Quality Department; assurance that relevant procedures are managed and continuously reviewed and improved for compliance and operating efficiencies; ensures that 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.
  • 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 Quality leadership throughout the product development process.
  • Provide leadership and guidance to ensure proper interface of Supplier and Manufacturing Quality 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 Quality.
  • 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 12 year’s experience in Quality Assurance/Quality Control with 5 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.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
  • Health, dental, vision, short- and long-term disability, and basic life insurance coverage
  • Paid time off, holiday pay, parental leave, and other health and wellness supports

Expected Pay Rate in Colorado from: $152,000.00
Compensation for the role will depend on a number of factors, including a candidate’s geographic location, qualifications, skills, competencies and experience and may fall outside of the range shown.

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

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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 Invitae (Formerly ArcherDx)

What’s the vibe like in the office?

Collaborative - when I walk through the Invitae 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 Invitae. 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 Invitae (Formerly ArcherDx) Perks + Benefits

Invitae (Formerly ArcherDx) Benefits Overview

At Invitae, our employees are the key to our continued success. Our culture is one of our most important strengths. A set of commitments we make to each other and to our customers to build a world-class organization in service of our mission. That is why Invitae proudly offers comprehensive perks and benefits program with choice and flexibility in mind.

Culture
Volunteer in local community
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Highly diverse management team
Unconscious bias training
Diversity manifesto
Someone's primary function is managing the company’s diversity and inclusion initiatives
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Team workouts
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Restricted work hours
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Happy Hours
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
Time allotted for learning
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