Governance & Risk Lead at Chain IQ responsible for S2C and P2P service delivery excellence. Collaborating closely with internal teams to manage risks and ensure quality compliance.
About the role
- Quality Systems Manager developing and maintaining Quality Management System at Ro, a direct-to-patient healthcare company. Ensuring compliance and quality during document management and system processes.
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
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
- 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
Benefits
- Competitive equity and benefits package
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