Manager, Quality Systems

Who We Are:

Click Therapeutics, Inc. develops, validates and commercializes software as prescription medical treatments for patients with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program has entered a pivotal, fully remote, randomized, controlled trial on the Verily platform for the treatment of Major Depressive Disorder (MDD) in up to 540 adults. Click is progressing a broad pipeline of Digital Therapeutics™ across a variety of high-burden therapeutic areas, including MDD, Schizophrenia, Migraine, Chronic Pain, Atopic Dermatitis, Acute Coronary Syndrome (ACS), Obesity and more.

About the Role:

The Quality Systems Manager plays a key role in the development of Click’s Software as a Medical Device (SaMD) products. This position leads a team of Quality System Analysts in the implementation of Click’s Quality Management System (QMS) to ensure compliance with evolving FDA and international medical device regulations. By working closely with Quality Engineering, Regulatory, CyberSecurity, and Clinical Operations, this role enables Click Therapeutics to bring high-quality, safe, and effective SaMD products to the commercial market. This is a highly visible, agile role within a rapidly growing pre-IPO company in a nascent and fast-growing space. 

Generally positions at Click can be on-site, remote or hybrid (an optimal combination of remote and on-site). Our headquarters is located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities. We also have dedicated spaces in central Miami, San Francisco, and Boston, and, in addition, via our partnership with Industrious, any Click employee can access co-working locations nationally.

The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space. 

Responsibilities:

• Leads the implementation of Click’s Quality Management System (QMS) processes throughout the organization
• Manages a growing team of Quality System Analysts supporting day-to-day QMS activities relating to document management, supplier evaluation, development tool validation, quality system training, complaint handling, CAPA management and more
• Partners with cross-functional teams (e.g., Clinical Operations, CyberSecurity) to continuously innovate and find comprehensive operational solutions that enable compliance with regulations and quality standards throughout the software development lifecycle
• Organizes and leads the team in quality system audits and liaises in Notified Body, FDA, or other third-party audits
• Ensures that the department objectives are planned and implemented in line with corporate goals and a growing product pipeline
• Continually researches and monitors industry trends, publications, FDA announcements, evolving international regulations and standards and applies learnings so that Click remains on the leading edge of digital therapeutic (DTx) development
• Promotes a culture of quality, leads quality training, and advocates for the importance of product quality throughout the organization.

Qualifications:

• 5+ years of experience working with medical device/drug quality systems; experience working with SiMD/SaMD preferred
• Advanced knowledge of medical device Good Manufacturing Practices (GMP) and related regulations, standards, and guidance (e.g., ISO 13485, ISO 14971, 21 CFR Part 820, IEC 62366, IEC 62304, IEC 82304, AAMI/TIR 45, AAMI/TIR 57); experience working with international regulations such as EU MDR preferred
• Working knowledge of Good Clinical Practices (GCP) for investigational device studies
• Auditor certification with experience conducting audits; lead auditor certification preferred
• Experience supervising quality management activities across multiple simultaneous projects 
• Highly motivated, driven, and excited about improving processes and procedures in an innovative, fast-paced environment
• Intellectually curious with experience researching and interpreting regulations and policies for practical applications
• Strong attention to detail and ability to write clear procedures, status reports, or other technical writing
• Bachelor’s Degree in engineering or other STEM related fiel

Benefits:

Stock options | Competitive salary with annual review | 401(k) matching | Annual performance-based cash bonus | Comprehensive medical benefits through Aetna | Flexible Spending Accounts | Life insurance and disability benefits | Open vacation policy / unlimited PTO | Generous paid parental leave | Commuter subsidies | Monthly catered lunches | Choice of Mac, Windows, or Linux equipment | Sponsored company events | Free, unlimited office snacks and beverages | Much more…

Equal Employment Opportunity:

Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics.