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ABOUT SINGULAR GENOMICS

Singular Genomics is inventing at the forefront of genomics, one of the world’s fastest-growing industries. We are a publicly traded life science technology company that is leveraging novel, next-generation sequencing (NGS) and multi-omics technologies to build products that empower researchers and clinicians. The G4 Sequencing Platform, our first commercially available product, is a powerful, highly versatile benchtop genomic sequencer designed to produce fast and accurate results. In development, the PX system leverages Singular’s proprietary sequencing technology, applying it as an in-situ readout to look at RNA and proteins in single cells and tissue.

We are committed to unlocking the potential of our core technologies to reshape the future of genomics. We offer a dynamic, fast-paced, results-oriented environment where employees can make a significant impact in a rapidly expanding company. Innovation, continuous learning, multi-disciplinary collaboration, and diversity of thought are pillars of our culture.

Our Headquarters are located on the Torrey Pines Mesa, in La Jolla, California at the center of the biotech hub. Our Manufacturing facility is in Sorrento Valley. This role reports to our HQ, Torrey Pines location.

Position Summary:

As the Director/Senior Director of Quality Assurance & Regulatory Affairs, you will be part of Singular’s leadership team with the primary responsibility of building and maintaining Singular’s Quality Systems and Quality Engineering. This role is strategically important to the success of Singular’s commercialization goals. The successful incumbent will have demonstrated deep proficiency in all aspects of Quality Systems, Compliance, and Regulatory Affairs.

This role is ideally suited for a candidate who is self-motivated and excited by a startup environment where opportunity to rise to frequent and diverse challenges is commonly encountered.

Responsibilities:

• Lead the development and implementation of an effective and efficient quality system for research-use products initially, followed by IVD products in the future.
• Work closely with R&D, Engineering, Process Development and Manufacturing to meet product quality objectives.
• Author quality system documents and help develop processes that support rapid development and innovation, while ensuring the right level of controls to consistently produce high-quality products.
• Build collaborative working relationships with Quality teams at customers, external vendors, and partners.
• Provide proactive strategic expertise to the Executive Leadership and Project Teams on Quality/Regulatory strategies, as well as approaches to risk management.
• Provide insights into the interpretation and application of global regulations and guidance documents.
• Implement and maintain the necessary programs to support the Corporate Quality Policy, the Quality System, and the Continuous Improvement initiatives.
• Lead the preparation and submission of regulatory agency applications, reports, or correspondence.
• Review all regulatory agency submission materials to ensure compliance with regulatory standards.
• Provide training, leadership, and represent a positive and enthusiastic role model to ensure high engagement across Singular teams.

Qualifications:

• Bachelor’s degree in science or engineering required; master’s degree / PhD preferred.
• Minimum of 7 years’ experience in Quality Assurance/Regulatory Compliance, with at least 5 years in a leadership position.
• Minimum of 7 years’ experience in medical devices or life science research tools, with at least 3 years of experience in IVD devices specifically.
• Demonstrated ability to implement an effective and efficient quality management system in a small company environment, supporting rapid innovation while delivering high-quality products.
• Strong analytical and problem-solving skills. Proven ability to influence in a highly matrixed environment.
• Strong knowledge of 21 CFR 820, ISO 9001:2015 and ISO 13485:2016; experience with international regulations (Europe, UK, Canada, Australia, etc.).
• Direct experience being interviewed in inspections and audits, and familiarity with audit support practices.
• Experience with development and manufacturing of complex biochemical reagents and scientific/diagnostic instruments is strongly preferred.
• Experience with 510(k) submissions is preferred.
• Ability to work in a fast paced and dynamic environment.
• Strong leadership and communication skills. Self-directed: needs little explicit direction.

The estimated base salary range for this role based in the United States of America is: $159,262 - $236,325. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Should the level of the role change during the hiring process, the applicable salary range may be updated accordingly. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package.

Singular Genomics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Please note: Singular Genomics does not accept agency resumes and is not responsible for any fees related to unsolicited resumes. Please do not forward resumes to Singular Genomics employees.