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Director, R&D Quality - job 2 of 2

Hims & Hers Health, Inc. (better known as Hims & Hers) is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are revolutionizing telehealth for providers and their patients alike. Making personalized solutions accessible is of paramount importance to Hims & Hers and we are focused on continued innovation in this space. Hims & Hers offers nonprescription products and access to highly personalized prescription solutions for a variety of conditions related to mental health, sexual health, hair care, skincare, heart health, and more.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS”. To learn more about the brand and offerings, you can visit hims.com and forhers.com, or visit our investor site. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

​​About the Role:

The Director of R&D Quality will play a critical role in ensuring that our product development processes meet the highest standards of quality, safety, and regulatory compliance. You will be responsible for overseeing the quality management systems (QMS) across all R&D projects, ensuring that new products are developed in accordance with industry standards and regulatory requirements. As a strategic leader, you will shape the direction of quality across the R&D division, partnering with cross-functional teams to drive continuous improvement, mitigate risks, and ensure that our products exceed expectations. This is a high-impact role that will require both deep technical expertise and strong leadership skills to manage and mentor a growing team of quality professionals.

You Will:

  • Lead Quality Strategy: Develop and implement R&D quality strategies aligned with the organization’s goals and regulatory standards. Provide strategic direction to the R&D team on maintaining quality throughout the product development lifecycle, from concept to commercialization.  Product categories include compounding sterile injectables, tablets, gummies, creams, etc. both Rx and OTC.  Focus with 503a and 503b compounding sites.

  • Oversee Quality Systems: Ensure that robust quality management systems (QMS) are in place for all R&D activities. Monitor compliance with internal and external standards, including ISO, FDA, and other relevant regulatory bodies, ensuring that documentation and processes are fully aligned with these standards.

  • Collaborate Across Functions: Partner with R&D leaders, project teams, regulatory affairs, and manufacturing to integrate quality into every phase of product development. Provide guidance on design controls, validation, and risk management to drive high-quality outcomes.  Quality representative on R&D teams for new product development.

  • Ensure Regulatory Compliance: Lead the efforts to maintain compliance with relevant regulations (e.g., FDA, USP,). Drive Continuous Improvement: Identify areas for process improvement and lead initiatives to optimize quality assurance practices. Foster a culture of quality and continuous improvement, focusing on proactive risk mitigation and process refinement.

  • Risk Management: Lead risk management efforts, including performing hazard analysis, failure modes and effects analysis (FMEA), and risk assessments to proactively address potential quality issues.

  • Documentation & Reporting: Ensure the development and maintenance of all quality-related documentation, including protocols, reports, and validation plans. Provide regular updates and quality metrics to senior leadership on the progress of R&D quality initiatives.

You Have:

  • Bachelor’s degree or equivalent in Science or Pharmacy degree preferred. 

  • Minimum of 10+ years of experience in quality management within the R&D or product development environment, with at least 5 years in a leadership role.

  • Experience in regulated industries such as pharmaceuticals, biotechnology, medical devices, or consumer goods.

  • Proven track record of developing and implementing quality systems and processes for new product development.

  • Strong understanding of R&D processes, including design control, validation, risk management, and regulatory requirements.

  • Familiarity with relevant quality standards (e.g., FDA, USP, etc.etc.).

  • Excellent leadership, communication, and interpersonal skills, with the ability to influence cross-functional teams and senior leadership.

  • Demonstrated ability to drive continuous improvement and problem-solving in a fast-paced, innovative environment.

  • Strong analytical skills with the ability to interpret complex data and make data-driven decisions.

 

Our Benefits (there are more but here are some highlights):

  • Competitive salary & equity compensation for full-time roles

  • Unlimited PTO, company holidays, and quarterly mental health days

  • Comprehensive health benefits including medical, dental & vision, and parental leave

  • Employee Stock Purchase Program (ESPP)

  • Employee discounts on hims & hers

  • 401k benefits with employer matching contribution

  • Offsite team retreats

 

#LI-Remote

 

We are focused on building a diverse and inclusive workforce. If you’re excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.

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What You Should Know About Director, R&D Quality, hims & hers

At Hims & Hers Health, Inc., we are on the cutting edge of health and wellness solutions, and we're seeking a passionate Director of R&D Quality to join our innovative team in San Francisco. In this role, you will play a pivotal part in ensuring that every aspect of our product development meets rigorous quality, safety, and regulatory standards. Your keen attention to detail will help shape the quality management systems (QMS) that guide our R&D projects from concept to commercialization, particularly in areas like sterilized injectables, tablets, and more. As a strategic leader, you won't just oversee quality processes; you'll collaborate cross-functionally to drive continuous improvement and enhance product outcomes. You'll lead a dedicated team of quality professionals, inspiring them to maintain compliance with internal and external regulations, and you'll take the helm on risk management initiatives that proactively mitigate potential issues. If you have a strong background in quality management, particularly in regulated industries like pharmaceuticals or biotechnology, and a desire to foster a culture of excellence through teamwork, Hims & Hers provides the perfect environment for you to shine. With our focus on personalized health solutions and a unique commitment to team well-being, you'll find that every day brings new opportunities for innovation and impact in the world of telehealth. Join us, and let's help the world feel great together!

Frequently Asked Questions (FAQs) for Director, R&D Quality Role at hims & hers
What are the responsibilities of the Director of R&D Quality at Hims & Hers?

The Director of R&D Quality at Hims & Hers is responsible for developing and implementing quality strategies, overseeing quality management systems (QMS) for R&D projects, collaborating with cross-functional teams, ensuring regulatory compliance, and leading continuous improvement initiatives. This role involves guiding the R&D team on maintaining quality throughout the product lifecycle and driving high-quality outcomes.

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What qualifications are needed for the Director of R&D Quality position at Hims & Hers?

Candidates for the Director of R&D Quality role at Hims & Hers should possess a Bachelor's or equivalent degree in Science or Pharmacy, with a preferred 10+ years of quality management experience in R&D or product development. At least 5 years should be in a leadership capacity, demonstrating expertise in regulated industries such as pharmaceuticals or biotechnology, while fostering strong leadership and communication skills.

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How does the Director of R&D Quality contribute to product safety at Hims & Hers?

The Director of R&D Quality at Hims & Hers ensures product safety by overseeing compliance with industry standards and regulatory requirements, leading risk management efforts, and implementing robust quality management systems. By collaborating with R&D leaders and cross-functional teams, they mitigate risks and promote continuous quality improvements throughout the product development process.

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What type of team will the Director of R&D Quality manage at Hims & Hers?

As the Director of R&D Quality at Hims & Hers, you will manage a growing team of quality professionals. Your leadership will be pivotal in mentoring team members, fostering a culture of excellence, and ensuring that everyone is aligned with our quality goals and regulatory compliance standards across all R&D projects.

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What are the key benefits offered to the Director of R&D Quality at Hims & Hers?

The Director of R&D Quality at Hims & Hers is offered a competitive salary, equity compensation, unlimited PTO, comprehensive health benefits, and an Employee Stock Purchase Program (ESPP). Additional perks include discounts on products, a 401k plan with employer matching, and opportunities for offsite team retreats.

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Common Interview Questions for Director, R&D Quality
Can you describe your experience with quality management systems in R&D?

Discuss your previous roles where you've implemented or managed quality management systems in R&D, giving specific examples of how you ensured compliance and drove quality standards within a team.

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How do you approach risk management in product development?

Explain your methodology for conducting risk assessments, including techniques like FMEA, and describe how you've utilized these assessments to mitigate risks and improve quality outcomes in past projects.

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What strategies have you used to lead a team toward continuous improvement?

Detail the continuous improvement strategies you've employed, such as training sessions or process audits, and share specific outcomes that resulted from these initiatives and their impact on team performance.

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How do you ensure compliance with FDA and ISO standards?

Discuss your familiarity with FDA and ISO regulations and your methods for maintaining compliance, including documentation practices and regular audits, to ensure that products meet all safety and quality requirements.

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Tell us about a time you had to influence a cross-functional team on a quality issue.

Provide a concrete example of when you effectively communicated the importance of quality to a cross-functional team, the challenges faced, and how your leadership helped resolve the issue.

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What techniques do you use for effective communication with senior leadership?

Describe your communication style and the tools or methods you use to keep senior leadership informed on quality metrics and project progress, emphasizing the importance of transparency and accountability.

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How do you balance regulatory compliance with innovative product development?

Explain how you advocate for innovation while ensuring compliance, including examples of how you've navigated challenges to maintain quality standards without stifling creativity.

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What experience do you have with mentoring and developing quality team members?

Share your mentoring philosophy, detailing how you support the professional development of quality team members, including any specific training programs or initiatives you've led.

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How do you handle a situation where a product does not meet quality expectations?

Discuss your approach to investigating and resolving quality failures, including the analysis, documentation, and corrective actions taken to prevent future occurrences.

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What motivates you to maintain high-quality standards in R&D?

Reflect on your personal values regarding quality and how your passion for health and wellness drives your commitment to excellence in the R&D processes at Hims & Hers.

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BENEFITS & PERKS
Dental Insurance
Disability Insurance
Vision Insurance
Equity
Paid Time-Off
Medical Insurance
Mental Health Resources
Paid Holidays
Company Retreats
FUNDING
SENIORITY LEVEL REQUIREMENT
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Full-time, remote
DATE POSTED
March 13, 2025

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