Associate Manager, Corporate Quality (Post-Market, External Partnerships and Testing)

Employment Type: Full-time

Position Overview

Ro is a direct-to-patient healthcare company dedicated to making healthcare easier and more effective. As a vertically integrated company, Ro uniquely offers nationwide telehealth, labs, and pharmacy services, providing a seamless, end-to-end healthcare experience from diagnosis to ongoing care. Ro has positively impacted millions of patients across the United States, reaching every county and a significant portion of primary care deserts. The company has received numerous accolades, including recognition as a Fortune Best Workplace in New York and Health Care for four consecutive years (2021-2024), Best Workplace for Parents (2021-2023), and was named a CNBC Disruptor 50 in 2022.

The Associate Manager, Corporate Quality (Post-Market, External Partnerships and Testing) is a vital role within the Corporate Quality team. This position is responsible for overseeing quality assurance from the technical transfer/go-to-market phase through the end of life for non-pharmacy products. The role is crucial for maintaining the highest standards of quality, compliance, and innovation across our supplier, vendor, third-party pharmacy, and testing facility partnerships.

Key Responsibilities

• Oversee Quality Assurance: Manage quality assurance for on-market products from commercialization to end of life, ensuring adherence to all relevant standards and regulations.
• Maintain Good Documentation Practices (GDP): Ensure accurate and compliant documentation for product specifications, formula approvals, and audit records.
• Manage Third-Party Testing: Coordinate all ongoing testing activities, ensuring proper record retention for results, Certificates of Analysis (CoA), and other pertinent documentation.
• Support Validation/Qualification: Collaborate cross-functionally with R&D and key stakeholders to support product, process, and material validations/qualifications, ensuring proper documentation and compliance.
• Develop and Maintain QMS: Assist in the development, implementation, and maintenance of a robust Quality Management System (QMS) specifically for post-market quality.
• Conduct Vendor Audits: Perform audits of vendors to verify their adherence to quality standards and overall compliance requirements.
• Internal Audit Team Member: Act as a key member of the Internal Audit Team, assessing and improving quality processes.
• Support Product Improvement: Contribute to product improvement initiatives, including the development and execution of Corrective and Preventive Actions (CAPA) and Root Cause Analysis (RCA) programs.
• Stay Informed: Keep abreast of industry trends and regulatory changes to ensure continuous compliance and adoption of best practices.
• Cross-Functional Collaboration: Work collaboratively with various teams to uphold quality standards throughout the product lifecycle.
• Drive Process Improvements: Identify and implement process improvements using best practices to enhance efficiency and reduce defects.
• Utilize Quality Tools: Employ quality tools and methodologies to optimize processes and improve product reliability.

Requirements

• Bachelor's degree with a science focus (e.g., Biology, Chemistry).
• Strong understanding of best quality practices, including compounding pharmacy standards, cGMP, cdGDP, and cGLP.
• Knowledge of regulatory compliance related to Quality Systems, regulatory submissions, and audits.
• Highly independent with a proactive approach to identifying and acting on process improvement opportunities.
• Proven experience in post-market quality oversight, including conducting vendor and supplier audits.
• Ability to articulate the importance of quality standards and regulations in a cross-functional environment.
• Passion for building scalable quality programs to support company growth.
• Determination and personal flair in work approach.

Company Information

Ro is a leading direct-to-patient healthcare company committed to delivering the easiest and most effective care possible. Ro's vertically integrated platform provides nationwide telehealth, labs, and pharmacy services, creating a comprehensive and convenient healthcare experience for patients. Since its founding in 2017, Ro has served millions of patients and has been recognized for its workplace culture and innovation.