Associate Director of Quality Control at Invitae (Formerly ArcherDx)
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 of Quality Control will be primarily responsible for the Quality Control laboratories. This position will be responsible for hiring and developing the personnel, leading the laboratory, process improvements and strategy to ensure Invitae provides its internal and external customers with industry leading and innovative products and services. This role shall lead the QC lab 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:
Job performance will involve a variety of activities including:
- Promote quality culture throughout Archer, ensuring compliance to policies, procedures, and regulations sustained through reinforcement of quality at all levels.
- Oversee the quality control program including development of staff and process improvements for test method validation, material release, and stability.
- Lead by example to create an inclusive culture that values high engagement.
- Work with internal and external resources to maintain QC laboratory infrastructure including equipment, reagents, etc.
- Establish department goals and accomplish results within budget and on schedule.
- Build and maintain positive and collaborative relationships cross-functionally to develop and improve the method transfer and phase appropriate qualification/validation of methods.
- Monitor and trend data including routine record review of test data.
- Gather data for continuous process improvement.
- Develop, revise and review SOPs, qualification/validation protocols and reports
- 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.
- Minimum of 10 years of experience in Quality roles with a minimum of 8 years in a laboratory setting and 5 years in a leadership position
- Bachelor's Degree required, Master's preferred
- Working knowledge of regulatory requirements ISO13485:2016, ISO 14971:2012, CFR 21 820. CAP CLIA and laboratory standards preferred.
- 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
- Able to organize, prioritize, and delegate tasks efficiently
In Colorado, our competitive compensation package includes a base salary starting From $169,900.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.