Ro is the healthcare technology company building a patient-centric healthcare system. Ro’s vertically-integrated primary care platform powers a personalized, end-to-end healthcare experience from diagnosis, to delivery of medication, to ongoing care. With a nationwide provider network, in-home care API, and proprietary pharmacy distribution centers, Ro is the only company to seamlessly connect telehealth and in-home care, diagnostics, and pharmacy services nationwide to provide high-quality, affordable healthcare without the need for insurance. Since 2017, Ro has facilitated more than six million digital healthcare visits in nearly every county in the United States, including 98% of primary care deserts. Ro also provides its patient-centric solutions including Workpath, its in-home care API, and Kit, its at-home diagnostic testing service, to other healthcare companies. Visit Ro.co for more information.
Ro was named #2 in Wellness on Fast Company’s 2019 list of the World’s Most Innovative Companies, listed by Inc. Magazine as a Best Place to Work in 2020 and 2021, and named one of FORTUNE’s 2021 Best Workplaces In Health Care.
Ro is looking for an enthusiastic, energetic candidate who is passionate about process and product quality to lead the quality program for our in-house compounding unit.
The Senior Manager, Compounding Quality Assurance will be responsible for building the QC/QA process at Ro’s first non-sterile compounding center in Boynton Beach Florida, and ensuring the facility meets or exceeds all local and federal regulatory requirements for non-sterile compounding. This role will be charged with building out the quality team and program that will ensure Ro’s compounding operation exceeds all industry standards for safety and compliance.
As the Senior Manager, Compounding Quality Assurance, you will be focused on building the founding Quality Management System that will form the basis of the quality program for Ro’s non-sterile compounding operation. You will work closely with the compounding pharmacy specialist responsible for the day-to-day operations of the compounding center to build a world-class program ensuring all necessary environmental and procedural controls are in place to provide a world-class operation. In addition, you will work closely with the broader compliance team to ensure we are meeting record-keeping requirements, keeping employees up to date on training, and keeping abreast of the evolving licensing requirements across all 50 states.
As a key member of our fast-growing start-up, you need to have a passion for building scalable programs that can be used to support the future growth of compounding operations. You obsess over the small things.
The role will require strong communication and strategic planning skills as well as the ability to effectively manage cross-functional relationships. In addition, a strong familiarity with best practices in compounding pharmacy practice, licensing/accreditations, regulatory compliance, QC/QA, and CQI is a must.
What You’ll Do:
- Develop and implement a robust quality program for Ro’s non-sterile compounding facilities including, but not limited to, the following components of the QC/QA process: lot release management, stability review, environmental monitoring, maintenance of quality agreements, the release of products for dispensing, product inspection audits, and preparation + development of Standard Operating Procedures
- Works with the Ro Quality and Safety Manager to conduct initial and routine vetting of vendors, including audits to ensure compliance and quality standards are being met by our partners as needed
- Work with a cross-functional team of legal, compliance, patient care, and product designers to design and implement a recall program for compounded products
- Ensure compliance with relevant regulatory statutes and guidance including USP <3>, USP <795>, USP <800>, USP <1163>, FDA Guidance and MOU docs, regs + requirements for all 50 states + DC, and more
- Responsible for designing, implementing, and actioning proactive and retrospective process improvement programs, including the CAPA/RCA process
- Manage and evaluate (trending) product complaints, deviations, Corrective Actions, and Preventive Actions (CAPAs)
- Serve as the primary liaison between Ro and regulatory authorities regarding quality matters, including hosting inspections and responding to observations
- Collaborate closely with product and engineering teams to ensure the operational roadmap and priorities are in line with Ro’s pharmacy roadmap
- Organize, prioritize, and communicate changes to compounding standards and keep stakeholders aware of upcoming requirements
- Assist Ro’s Sr. Director of Strategy and Process in obtaining relevant accreditations, including PCAB, URAC, DPA (formerly VIPPS), and others
What You’ll Bring to the Team:
- 5+ years of experience leading Quality and/or Quality Assurance function in the pharmacy compounding space, or pharmaceutical industry
- 5+ years of experience as the primary party responsible for ensuring compliance with multi-state pharmacy practice regulations relevant to the practice of non-sterile compounding (USP, FDA, BoP, etc.)
- Experience in compounding topical preparations is a big plus!
- Bachelor’s degree in biology, chemistry, or biochemistry (Bonus for Ph.D. level degree)
- Background/experience working in a cGMP environment is strongly preferred
- Strong attention to detail and ability to think strategically and tactically
- Six Sigma or other quality improvement certification strongly preferred
- Organized, analytical, and detail-oriented
- 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
- Daily driving distance to Boynton Beach, FL (job requires the candidate to be onsite daily)
Benefits + Perks:
- Full medical, dental, and vision insurance + OneMedical membership
- Healthcare and Dependent Care FSA
- 401(k) with company match
- Unlimited PTO
- Wellbeing + Learning & Growth reimbursements
- Paid parental leave + Fertility benefits
- Pet insurance
- Student loan refinancing
- Virtual resources for mindfulness, counseling, fitness, and physical therapy
To apply for this job please visit jobs.lever.co.