Quality Assurance Manager

Invitae is a leading medical genetics company trusted by millions of patients and their providers to deliver timely genetic information using digital technology. We aim to provide accurate and actionable answers to strengthen medical decision-making for individuals and their families. Invitae's genetics experts apply a rigorous approach to data and research, serving as the foundation of their mission to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people.

As the Quality Assurance Manager, you will be responsible for clinical quality of laboratory operations. Working closely with the Director, Quality Assurance & Regulatory Affairs, you will provide quality oversight for development and commercial services.

Location: Metropark, NJ, this is a hybrid position requiring 3 days onsite.

What you'll do:

• Guides the implementation, maintenance, and monitoring of processes and procedures to ensure compliance with relevant guidance and requirements.
• Handles document and record control.
• Leads the training programs.
• Supports the tracking, monitoring, and presentation of operational and quality metrics
• Initiates or supports as needed quality improvements initiatives to improve performance and/or mitigate quality or compliance risks.
• Provides guidance in assessing non-compliance events and supports the team effort to define corrective and preventive actions as well as supervising their effectiveness.
• Supports the internal audit program and supplier qualification program
• Assures executive staff is advised of any issues that may adversely impact the Quality System.
• Supports independent monitoring of study conduct to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with internal procedures and follow regulations.
• Liaise with external entities such as customers, auditors, and/or regulatory agencies on matters relating to the Quality Management System at the discretion of Quality Assurance Director.
  
  

What you'll bring:

• 5+ years of experience in the Healthcare industry (CAP/CLIA/ISO environment) with 2 years of GCP/GCLP-related Quality Assurance experience.
• Bachelors in science, biological science, computational biology, or biotechnology.
• CQA auditor certification is a plus
• Strong organizational and leadership skills to communicate to multi-disciplinary project teams.
• Ability to comprehend regulations and guidance documents and technical information related to equipment, processes, and regulatory expectations.
• The ability to think strategically and maintain an attention to detail.
• Capable of working independently with little supervision and interacting with staff in a fast-paced sometimes pressure filled environment.
• Excellent written and verbal communication skills coupled with strong negotiation and decision-making skills.
• Strong comprehension while applying critical thinking skills to evaluate requirements.
• Ability to present data and defend approaches to inspectors.
  
  

This salary range is an estimate, and the actual salary may vary based on a wide range of factors, including your skills, qualifications, experience and location. This position is eligible for benefits including but not limited to medical, dental, vision, life insurance, disability coverage, flexible paid time off, Spring Health, Carrot Fertility, participation in a 401k with company match, ESPP, and many other additional voluntary benefits. Invitae also offers generous paid leave programs so you can spend time with your new child, recover from your own illness or care for a sick family member.

New Jersey Pay Range

$105,200—$131,500 USD

Please apply even if you don’t meet all of the “What you bring” requirements noted. It’s rare that someone checks every single item, it’s ok, we encourage you to apply anyways.

Join us!

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.

We truly believe a diverse workplace is crucial to our company's success and to better serve our diverse patients. Your input is especially valuable. We’d greatly appreciate it if you can take a quick moment to make your selection(s) below. Submissions will be anonymous.

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