Corporate Quality Manager

Ro • New York, NY

1d • Hybrid

About The Position

Ro is a direct-to-patient healthcare company with a mission of helping patients achieve their health goals by delivering the easiest, most effective care possible. Ro is the only company to offer nationwide telehealth, labs, and pharmacy services. This is enabled by Ro's vertically integrated platform that helps patients achieve their goals through a convenient, end-to-end healthcare experience spanning from diagnosis, to delivery of medication, to ongoing care. Since 2017, Ro has helped millions of patients, including one in every county in the United States, and in 98% of primary care deserts.

Ro has been recognized as a Fortune Best Workplace in New York and Health Care for four consecutive years (2021-2024). In 2023, Ro was also named Best Workplace for Parents for the third year in a row. In 2022, Ro was listed as a CNBC Disruptor 50.

As a Quality Systems Manager, you will be responsible for the development, implementation, maintenance, and continuous improvement of the company’s Quality Program / Quality Management System (QMS). This role is critical to ensuring controlled document management, training systems, and quality event processes and metrics meet applicable regulatory and internal requirements. In this role, you will own the document lifecycle and quality system infrastructure, overseeing creation, revision, approval, training linkage, and periodic review of controlled documents. You will partner cross-functionally to implement and maintain procedural compliance, drive system-level improvements, and ensure quality data is accurately captured, trended, and communicated to cross-functional team members. Through tracking and trending of quality event metrics (nonconformances, deviations, CAPAs), you will support a data-driven, inspection-ready quality culture.

This role will partner closely with Pharmacy and Product Quality. This role participates in internal and third-party audits and supports inspection readiness activities across Ro. This role will report to the Senior Manager, Quality Systems and Regulatory Affairs on the Clinical team.

Requirements

• Bachelor's degree in an appropriate Science discipline
• 6+ years of experience in a Quality Assurance / Quality Systems role within a regulated environment
• Demonstrated experience supporting or leading the implementation and maintenance of a Quality Management System in a regulated environment
• Past use of data visualization tools and experience tracking and trending metrics to support data-driven decision making
• Experience in SOP development, personnel training and tracking and documenting deviations, CAPAs and other quality events and metrics
• Internal and/or external audit experience
• Excellent verbal and written communication skills
• Strong attention to detail and ability to think strategically
• Competency in Microsoft and Google Suite systems. Looker Studio and Airtable experience is a plus
• Ability to travel up to 20% of the time

Nice To Haves

• Working knowledge of cGMP requirements, such as 21 CFR 820 or 21 CFR 210/211, preferred
• Experience in drug compounding, specifically USP 795 or USP 797 is a plus

Responsibilities

• Manage the ongoing development, implementation, and maintenance of a robust Quality Program / Quality Management System across all parts of Ro
• Lead tracking, trending, and analysis of quality system metrics, including: a) deviations and nonconformances, b) CAPAs and effectiveness checks, c) SCARs and recurring quality signals, and d) complaints and product defects
• Prepare and present quality system data and trends to cross-functional partners
• Represent Quality Systems on cross-functional project teams, ensuring clear communication of quality system requirements, procedural expectations, and deliverables
• Serve as system owner for document control, including: a) identifying the need for new or revised controlled documents b) drafting, reviewing, and coordinating approval of SOPs, policies, work instructions, and forms, and c) managing document lifecycle activities, including periodic review and archival
• Coordinate and maintain training content and training assignment linkage to controlled documents
• Support inspection readiness by ensuring quality system documentation is current, accurate, and traceable and by creating visibility of Ro’s audit playbook for all employees
• Act as a member of the internal audit team, supporting execution of internal audit schedules and follow-up activities
• Support third-party audits and vendor quality activities, including audit scheduling and follow-up where applicable

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level