Manager, Corporate Quality (Pre-Market)

Who We Are

Ro is a direct-to-patient healthcare company with a mission of helping as many patients as possible achieve their health goals. Ro is the only company to offer telehealth care at-home diagnostic testing labs and pharmacy services nationwide. This is enabled by Ro's vertically integrated platform that helps patients achieve their goals through a convenient end-to-end healthcare experience spanning from diagnosis to delivery of medication to ongoing care. Since 2017 Ro has helped millions of patients in nearly every single county in the United States including 98% of primary care deserts.

Ro was recognized as a CNBC Disruptor 50 in 2022 listed by Inc. Magazine as a Best Place to Work in 2022 for our third consecutive year and named one of FORTUNE's 2022 Best Medium Workplaces.

As a Manager Corporate Quality - Pre Market Development you will work on the Corporate Quality team owning  quality assurance for the new product development pipeline to ensure the highest standards of quality and innovation. You will manage the development and implementation of quality management systems lead product development projects from concept to launch and ensure compliance with industry regulations and standards along the way. You will partner closely with Product Development to ensure good documentation practices are maintained for all development records (formulation records product specifications). You will also partner closely with the Operations team to manage Ro’s supplier onboarding and audit program.  This position will collaborate with the broader Corporate Quality team to ensure proper oversight of our Quality Management System and related Quality Events. You will also manage Corporate Quality’s participation in regulatory submissions. This role will report to the Senior Director Corporate Quality on the Clinical team.

Who are you? You have a strong familiarity with best quality practices (cGDP cGLP cGMP) regulatory compliance related to Quality Systems regulatory submissions and audits. You have experience overseeing quality for product development and vendor / supplier management. You’re excited to learn new areas of the industry think big and you’re able to drive quality with focus communicating the “why” behind quality and regulations effectively in a cross-functional environment. You’re a strong advocate for your team and have the will to win while putting your own personal twist into your work. 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 future growth of compounding operations.

What You'll Do:

• Own Quality for New Product Development and Product Improvement projects from concept to commercialization including leading new vendor/partner onboarding NPD Lab Quality oversight development of product specifications/formulations/prototypes.

• Coordinate and own all Product Development 3rd party testing including oversight of product stability testing and record retention

• Support product process and material validations/qualifications working cross-functionally with R&D and department level stakeholders to ensure proper documentation and retention.

• Assist in development implementation and maintenance of a robust quality program / Quality Management System as it relates to the Product Development pipeline.

• Serve as the main liaison between Corporate Quality and Regulatory for all product regulatory submissions including FDA 510k submissions and other Premarket Approval submissions.

• Conduct initial vendor audits to ensure quality standards and overall compliance are being met by all partners

• Act as a member of the internal audit team to help successful execution of internal audit schedules to help maintain audit readiness.

• Assist department leadership with designing implementing and actioning proactive and retrospective product improvement programs including a CAPA/RCA process.

• Stay abreast of changing industry requirements.

• Collaborate with cross-functional teams to ensure quality standards are met throughout the product life cycle.

• Identify opportunities for process improvements and implementation of best practices.

• Utilization of quality tools and methodologies to improve processes and reduce product defects.

What You’ll Bring to the Team:

• Bachelor's degree with a science focus (Biology Chemistry Biochemistry Engineering etc.)

• 5+ years working in New Product Development / New Product Introduction with a focus on Quality Assurance.

• 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

• Florida Pharmacist / Pharmacy Technician Licensure or ability to obtain strongly preferred

• Previous Vendor and Internal Audit experience with certification as Quality Auditor or in Quality Management Systems a plus.

• 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.

We’ve Got You Covered:

• 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

The target base salary for this position ranges from $113000 to $136500 in addition to a competitive equity and benefits package (as applicable). When determining compensation we analyze and carefully consider several factors including location job-related knowledge skills and experience. These considerations may cause your compensation to vary.

Ro recognizes the power of in-person collaboration while supporting the flexibility to work anywhere in the United States. For our Ro’ers in the tri-state (NY) area you will join us at HQ on Tuesdays and Thursdays. For those outside of the tri-state area you will be able to join in-person collaborations throughout the year (i.e. during team on-sites).

At Ro we believe that our diverse perspectives are our biggest strengths — and that embracing them will create real change in healthcare. As an equal opportunity employer we provide equal opportunity in all aspects of employment including recruiting hiring compensation training and promotion termination and any other terms and conditions of employment without regard to race ethnicity color religion sex sexual orientation gender identity gender expression familial status age disability and/or any other legally protected classification protected by federal state or local law.

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