Associate Director, Quality Management Systems (QMS)

| 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 Quality Management Systems, reporting to the Sr. Director Manufacturing Quality Operations and Quality Systems, ensures site level quality systems are appropriately designed, implemented, and measured for cGMP compliance and effectiveness. This role also develops and leads the Quality Management Systems team to implement plans to mitigate product and/ or process risks and to educate the facility on risk identification, root cause analysis, and investigative measures. Areas of responsibility include Change Control, Non-conformance and CAPA management, Document Control, Training, Supplier Quality, and Inspection Readiness. This role will be tasked with understanding the underlying quality issues and developing successful solutions, changing practices where necessary to ensure that standards are maintained.

RESPONSIBILITIES:

QMS responsibilities include but are not limited to: Quality Manual, Quality Management Review, Quality Planning, Training, Supplier Quality, Internal/External Audit, Change Control, Document Control, and Inspection Readiness.

  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance to established internal and external standards and guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Leads or participates in audit and inspection preparation, resolution of findings and liaises with auditing groups and inspectors through all stages of the audits (Internal, Customer/Partner, Regulatory).
  • Ensures the quality assurance programs and policies are maintained and improved regularly.
  • Drives continuous improvement for effective quality systems and to address recurring issues identified that impact the overall health of the quality system.
  • Represents the Quality Unit at various project meetings and provide quality input in the resolution of quality-related issues.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Leads a group or team of employees in the achievement of organizational goals. Guides, coaches, directs, and develops direct reports, and drives those practices throughout the organization.
  • Supports and maintains an environment that fosters communication and teamwork.
  • Participates in product development and design control activities as required.
  • Applies current Good Manufacturing Practice (CGMP) requirements, guidelines and practices.
  • Reviews, understands, and aligns with Invitae HIPAA Security policies and procedures.
  • Processes and handles European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.
EXPERIENCE:
  • Bachelor's degree in Engineering, Scientific or Technical discipline.
  • Minimum 7 years relevant (medical device, pharmaceutical) experience with 5+ years of managerial experience.
  • Prior experience with ISO 13485, EU MDR and U.S. 21 CFR 820 regulations for medical devices.
  • Certified Quality Manager, Engineer, or Auditor or previous auditing experience preferred.
  • Strong project/time management skills with the ability to organize and handle multiple priorities.
  • Excellent communication skills with the ability to positively influence key stakeholders without direct authority.
  • Quality Management System Software implementation experience preferred.
  • High attention to detail and accuracy.

In Colorado, our competitive compensation package includes a base salary starting Fromm $150,000. In determining the final salary offered we will evaluate a specific candidate geographic location, education, skills and experience.

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

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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