Product Quality & Safety Manager
About Ro
Founded in 2017, Ro is a patient-driven telehealth company that puts you in control of your health. We’re patients, just like you, building technology to make healthcare accessible, affordable, and maybe even enjoyable. Ro powers three digital health clinics -- Roman for men’s health, Rory for women’s health, and Zero for fighting smoking addiction -- as well as Ro Pharmacy, a simple and affordable online pharmacy where every medication is $5 per month. The company’s nationwide networking of physicians and pharmacies provides a personalized, end-to-end healthcare experience from online treatment to the delivery of medication and ongoing care. 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 earned its Great Place to Work Certification in 2020.
We’re looking for a Product Quality & Safety Manager to join the growing Medical Affairs team at our headquarters in New York! This role will report to our SVP Medical Affairs and Research and will be responsible for all things related to ensuring the products in our supply chain meet established standards for quality and safety.
Who are you? That's a great question. 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:
- Develop effective quality control processes.
- Devise and review specifications for products or processes.
- 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
- Coordinate with contract manufacturers and internal teams to gather raw material and finished product documentation and analyze its validity.
- Participate in CMO audits, as necessary, including preparation of audit plans and documentation of post-audit findings.
- Contribute to regulatory submissions such as product registrations and record requests.
- Responsible for keeping up with and understanding the regulatory environment and quality requirements for dietary supplements, personal care products, and OTC medications.
What You Bring to the Team:
- Bachelor's degree (BA or BS) required.
- 2-5 years of FDA-regulated product industry experience, including 2-4 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.
- Excellent communications, listening, and negotiation skills are necessary.
- Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
- Must have outstanding attention to details.
Benefits + Perks:
- Full medical, dental, and vision insurance + OneMedical membership
- Healthcare and Dependent Care FSA
- Commuter benefits
- 401(k)
- Unlimited PTO
- Fitness reimbursement
- Paid maternity/parental leave
We welcome qualified candidates of all races, creeds, genders, and sexuality to apply.
See our California Privacy Policy here.