Head Of Quality Management

Invitae (NYSE: NVTA) 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.

Head of Quality Management

San Francisco - Hybrid (In office 3 days a week)

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 clinical-grade genetic information affordable and accessible to guide health decisions across all stages of life.

The Head of Quality Management is a senior leadership role responsible for developing and implementing a comprehensive quality management strategy within an organization. The Head of Quality ensures that products, services, and processes meet or exceed established quality standards, regulatory requirements, and customer expectations. They provide strategic direction, create, develop and oversee quality initiatives, and drive continuous improvement efforts across the organization.

This position requires the incumbent to be present on site in the San Francisco Laboratory no less than 3 days per week.

What you’ll do:

• Cross-functional Collaboration: Collaborate with other functional leaders, such as operations, engineering, and customer service, to ensure a holistic approach to quality management. Work closely with product development teams to embed quality considerations into the design and development process.
• Support and Teach a culture of continuous improvement Drive a culture of continuous improvement by leading quality initiatives, such as Lean Six Sigma or Total Quality Management (TQM). Foster a mindset of quality awareness and accountability throughout the organization. Identify and work collaboratively across teams to implement process optimization opportunities to enhance quality, efficiency, and customer satisfaction throughout Operations and Customer Service teams
• Support QA staff following the Invitae Leadership Principles
• Develop and Manage the QMS strategy for Invitae. Develop and execute a robust quality management strategy aligned with the organization's overall objectives and business goals. Define quality policies, standards, and guidelines to ensure consistent adherence throughout the organization.
• Support the QM plan and selection of quality indicators; review and create as necessary novel quality indicators; carry out annual assessment of QM plan; report to the Head Laboratory Director and Management Team on how complaints, incidents, and plans of corrective actions are being implemented
• Ensure that processes within the QMS are aligned with business and regulatory requirements. Stay abreast of relevant industry regulations, standards, and best practices to ensure compliance. Collaborate with regulatory bodies and certification agencies to obtain and maintain necessary certifications, licenses, and approvals. Develop and maintain effective systems for managing regulatory compliance documentation.
• Create and monitor systems that enable the effective governance, risk management and administration of the QMS
• Report on the health of the QMS to the Head Laboratory Director and Management Team. Work with the Operations teams to establish and maintain a comprehensive quality reporting system that provides actionable insights to key stakeholders. Analyze quality data, metrics, and trends to identify root causes of issues and recommend corrective actions.
• Ensure that the QMS is effectively implemented throughout the organization

What you bring:

• 15+ years of experience leading Quality Assurance/Regulatory Affairs organizations
• Strong analytical and problem-solving skills, with the ability to analyze complex data sets and make data-driven decisions
• Six Sigma/Lean expertise
• Minimum of Bachelor’s Degree (preferably with additional certificates in QA / RA specialties)
• Excellent understanding of regulatory requirements and compliance standards relevant to the industry
• Excellent communication and influencing skills, with the ability to collaborate effectively across all levels of the organization
• Exceptional leadership and people management abilities, with a focus on building and developing high-performing teams
• Proven track record of successfully implementing quality initiatives and driving continuous improvement
• Proven experience in the field of Clinical Laboratory Medicine that emphasizes complex testing in a high-throughput setting
• Global business experience, including international QMS standards such as ISO9001, ISO15189 and ISO 13485

Leadership skills:

• In this role, you will be responsible for fostering an environment of open communication and collaboration, ensuring that each team member feels valued, heard, and inspired. Your ability to effectively convey ideas, articulate a compelling vision, engage with individuals at all levels, and bring other employees of Invitae along in a collaborative productive manner will be paramount. Through your powerful and persuasive communication skills, you will inspire trust and motivate your team and other teams with which QMS collaborates to achieve extraordinary results
• Maturity and compassion are indispensable qualities that you will bring to this position. Your balanced and level-headed approach, coupled with your genuine care for the well-being and growth of team members, will create a positive and supportive work culture. You will understand the importance of empathy and actively foster an inclusive environment where diverse perspectives are celebrated and nurtured
• One of the key aspects of this role is your dedication to coaching and training the team. You understand that true leadership is about more than just delegating tasks; it is about rolling up your sleeves and leading by example. Through hands-on guidance, you will empower your team members to unlock their full potential and achieve outstanding performance. Your willingness to demonstrate the "how" along with the "what" will ensure the development and success of each individual
• By joining our laboratory, you will become part of a vibrant and innovative community that puts our patients and provider customers first, recognizing that Invitae is not another biotech or software company, we are a healthcare company with a deep commitment to serving our patients. With access to state-of-the-art resources and a team of exceptional professionals, you will have the opportunity to contribute to outstanding clinical service and have a lasting impact on patients and their families
• We are seeking a dynamic and visionary leader to join our highly regarded, cutting-edge laboratory as a key member of our team

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.

California Pay Range

$172,500—$224,200 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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