Manager, Corporate Quality (Pre-Market)
To see similar active jobs please follow this link: Remote Management jobs
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 $113,000 to $136,500, 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.
See our California Privacy Policy here.
About the job
Manager, Corporate Quality (Pre-Market)
To see similar active jobs please follow this link: Remote Management jobs
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 $113,000 to $136,500, 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.
See our California Privacy Policy here.