Manager, Corporate Quality (Post-Market / External Quality)

Modern Fertility; United States; Hybrid; USD 114,000 - 142,000; Full time

Job summary

Join a forward-thinking healthcare company as a Manager of Corporate Quality, where your expertise in post-market surveillance and quality assurance will play a pivotal role in enhancing patient outcomes. This dynamic position involves overseeing compliance and quality management from product commercialization through its lifecycle. You'll collaborate cross-functionally, driving process improvements and ensuring adherence to industry regulations. With a commitment to patient-centric care, this role offers a unique opportunity to contribute to meaningful healthcare innovation while enjoying a competitive salary and a comprehensive benefits package.

Benefits

Full medical, dental, and vision insurance

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

Qualifications

• 5+ years in post-market surveillance and supplier/vendor management.
• Background in pharmaceutical or compounding pharmacy preferred.

Responsibilities

• Oversee Quality Assurance for on-market products ensuring compliance.
• Conduct Vendor Audits to ensure partners meet quality standards.

Skills

Post-Market Surveillance

Supplier/Vendor Management

Quality Tools and Methodologies

Analytical Skills

Communication Skills

Education

Bachelor's Degree in Science

Pharmacist/Pharmacy Technician Licensure

Tools

Quality Management Systems

Job description

Ro is a direct-to-patient healthcare company with a mission of helping patients achieve their health goals by delivering the easiest, most effective care possible. Ro is the only company to offer nationwide telehealth, labs, and pharmacy services. 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.

The healthcare system today is not designed to help patients achieve their goals. It’s designed around institutions such as hospitals and insurance companies. A patient centric healthcare system is one that is designed around the goals a patient wants to achieve. We’re building healthcare that puts patients in control, provides reactive and proactive care, has transparent pricing and process, is extremely effective and ridiculously convenient, and evolves over time based on patients’ goals.

Ro has been recognized as a Fortune Best Workplace in New York and Health Care for four consecutive years (2021-2024). In 2023, Ro was also named Best Workplace for Parents for the third year in a row. In 2022, Ro was listed as a CNBC Disruptor 50.

As a Manager, Corporate Quality (Post-Market, External Partnerships and Testing), you will be a key member of the Corporate Quality team, overseeing quality assurance from the technical transfer / go-to-market phase through the product’s entire lifecycle. This role is critical in upholding the highest standards of quality, compliance, and innovation with our suppliers, vendors, third-party pharmacy partners and testing facilities.

What You'll Do:

• Oversee Quality Assurance for on-market products from commercialization through end of life, ensuring compliance with all relevant standards and regulations.
• Maintain Good Documentation Practices (GDP), including product specifications, formula approvals, and audit documentation.
• Manage Third-Party Testing, coordinating all ongoing testing activities, ensuring appropriate record retention of results, Certificates of Analysis, and other relevant documentation.
• Support Product, Process, and Material Validations/Qualifications by working cross-functionally with R&D and key stakeholders to ensure proper documentation and compliance.
• Assist in Developing, Implementing, and Maintaining a robust Quality Management System (QMS) as it relates to post-market quality.
• Conduct Vendor Audits to ensure partners meet quality standards and overall compliance requirements.Act as a Key Member of the Internal Audit Team to assess and improve quality processes.
• Support Product Improvement Initiatives, including the development and execution of Corrective and Preventive Actions (CAPA) and Root Cause Analysis (RCA) programs.Stay Informed on Industry Trends and Regulatory Changes to ensure continued compliance and best practices.
• Collaborate Cross-Functionally to uphold quality standards throughout the product lifecycle.Identify and Drive Process Improvements, implementing best practices to enhance efficiency and reduce defects.
• Utilize Quality Tools and Methodologies to optimize processes and improve product reliability.

What You'll Bring to the Team:

• Bachelor's degree with a science focus (Biology, Chemistry, Biochemistry, Engineering, etc.)Illinois / Florida Pharmacist / Pharmacy Technician Licensure or ability to obtain, strongly preferred
• 5+ years working in post-market surveillance and supplier/vendor management.
• 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 preferredPrevious Vendor and Third-Party 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 methodologiesAbility 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 skillsIrrational 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

• We welcome qualified candidates of all races, creeds, genders, and sexuality to apply.

The target base salary for this position ranges from $114,800 to $141,500, in addition to a competitive equity and benefits package (as applicable). When determining compensation, we 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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