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.
We’re looking for a Senior Director, Product Quality Assurance to join the growing Medical Affairs team and lead our Product Quality Assurance team! This role will report to our VP Innovation R&D and will be responsible for all things related to ensuring that all manufactured and compounded products meet established standards for quality and safety.
Who are you? You are comfortable working within a new and evolving industry while handling several projects at the same time. You will have a major impact on Ro’s plans to scale and will work collaboratively with each department at the company. You are collaborative, friendly, flexible, and eager to learn about all facets of the business.
What You’ll Do:
- Lead and manage a team of Quality Assurance Managers
- Develop effective quality control processes across all consumer health products, including devices, supplements, skincare, and OTC
- Train and oversee QA managers who are devising and reviewing specifications for products or processes
- Ensure that Ro is pre-inspection ready for FDA, medical and pharmacy boards
- Establish requirements for raw material or intermediate products for suppliers
- Manage Ro’s contractual obligations under product quality agreements
- Develop and maintain a quality document management system
- Oversee the coordination of Ro with contract manufacturers and internal teams to gather raw material and finished product documentation and analyze its validity
- Create and implement a CMO audit plan and oversee the preparation of audit plans and documentation of post-audit findings
- Responsible for keeping up with and understanding the regulatory environment and quality requirements for dietary supplements, personal care products, and OTC medications
What You’ll Bring to the Team:
- Bachelor’s degree (BA or BS) required
- 10-15 years of FDA-regulated product industry experience, including 10 years in a Quality Audit role
- Knowledge of the regulatory landscape for the labeling and manufacturing of various FDA-regulated products including dietary supplements, prescription and OTC monograph drugs, and personal care products
- Knowledge of safety reporting requirements for FDA-regulated products
- Must be able to innovate, analyze, and solve problems with minimal supervisory input
- Must be a strong leader, manager, and collaborator as you work with legal, regulatory, pharmacy, corporate quality and safety, and our innovation R&D team
- Excellent communications, listening, and negotiation skills are necessary
- Excellent organizational and time management skills are needed to manage multiple ongoing projects simultaneously
- Must have outstanding attention to details
- Strong management skills with clear and effective communication
- Post-graduate degree in a scientific discipline
- Experience building a quality program from the ground up
- Regulatory Affairs Certification
- Project Management Certification and Training
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.