Director - R&D Quality

​​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 & Apostrophe online products

• 401k benefits with employer matching contribution

• Offsite team retreats

 

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