Manager, Corporate Quality

Summary

Join Ro, a leading direct-to-patient healthcare company, as a Manager, Corporate Quality (Post-Market, External Partnerships and Testing). You will play a key role in ensuring the highest quality standards across the product lifecycle, from commercialization to end-of-life. This involves overseeing quality assurance, managing third-party testing, conducting vendor audits, and supporting product improvement initiatives. You will collaborate with various teams, maintain robust documentation, and stay informed on industry trends and regulations. The position requires a Bachelor's degree in a science field and 5+ years of experience in post-market surveillance and supplier/vendor management. Ro offers a competitive salary and benefits package, including full medical, dental, and vision insurance, 401(k) matching, flexible PTO, and more. The role allows for flexibility, with a hybrid work model.

Requirements

• Bachelor's degree with a science focus (Biology, Chemistry, Biochemistry, Engineering, etc.)
• 5+ years working in post-market surveillance and supplier/vendor management
• Ability to travel up to 40% of time
• Proficiency in quality tools and methodologies
• Ability to work effectively in a fast-paced, dynamic environment
• Strong analytical skills with attention to detail and ability to think strategically and tactically
• Outstanding written and verbal communication skills
• Irrational passion for building the future of healthcare with an emphasis on quality processes to drive successful patient outcomes

Responsibilities

• Oversee Quality Assurance for on-market products from commercialization through end of life, ensuring compliance with all relevant standards and regulations
• Maintain Good Documentation Practices (GDP), including product specifications, formula approvals, and audit documentation
• Manage Third-Party Testing, coordinating all ongoing testing activities, ensuring appropriate record retention of results, Certificates of Analysis, and other relevant documentation
• Support Product, Process, and Material Validations/Qualifications by working cross-functionally with R&D and key stakeholders to ensure proper documentation and compliance
• Assist in Developing, Implementing, and Maintaining a robust Quality Management System (QMS) as it relates to post-market quality
• Conduct Vendor Audits to ensure partners meet quality standards and overall compliance requirements
• Act as a Key Member of the Internal Audit Team to assess and improve quality processes
• Support Product Improvement Initiatives, including the development and execution of Corrective and Preventive Actions (CAPA) and Root Cause Analysis (RCA) programs
• Stay Informed on Industry Trends and Regulatory Changes to ensure continued compliance and best practices
• Collaborate Cross-Functionally to uphold quality standards throughout the product lifecycle
• Identify and Drive Process Improvements, implementing best practices to enhance efficiency and reduce defects
• Utilize Quality Tools and Methodologies to optimize processes and improve product reliability

Preferred Qualifications

• Illinois / Florida Pharmacist / Pharmacy Technician Licensure or ability to obtain, strongly preferred
• Background in pharmaceutical or compounding pharmacy with knowledge of industry regulations ( FDA 503A/B Compounding , FDA 21 CFR 210/211/820, CAP/CLIA for laboratories) and any related certification, strongly preferred
• Previous Vendor and Third-Party Audit experience with certification as Quality Auditor or in Quality Management Systems a plus

Benefits

• Full medical, dental, and vision insurance + OneMedical membership
• Healthcare and Dependent Care FSA
• 401(k) with company match
• Flexible PTO
• Wellbeing + Learning & Growth reimbursements
• Paid parental leave + Fertility benefits
• Pet insurance
• Student loan refinancing
• Virtual resources for mindfulness, counseling, and fitness