Senior Manager, Quality Systems
Job Location:
Los Alamitos, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 redefining healthcare by putting the customer first and delivering access to care that is affordable accessible and personal from diagnosis to treatment to delivery. No two people are the same so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions were making better health outcomes easier to achieve.
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 and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: The Sr. Manager Quality Systems serves as the subject matter expert (SME) and owner of the site Quality Management System (QMS) within a sterile cGMP manufacturing environment. This role is responsible for designing establishing maintaining and continuously improving the QMS framework including Document Control and Data Integrity Change Control Deviations and CAPA Training Internal Audit and Management Review in alignment with FDA cGMP (21 CFR 210/211/11) Section 503B and other applicable standards. The successful candidate will bring deep Quality Systems expertise a builders mindset and a proven track record of strengthening compliant audit-ready systems in sterile pharmaceutical operations. This individual will be central to ensuring inspection readiness regulatory compliance and a culture of continuous improvement across the site. This role will begin as an individual contributor and site SME for Quality Systems with the opportunity to build and lead a team as the QMS and the organization mature. Lead the design implementation and continuous improvement of the site QMS ensuring compliance with cGMP 503B and applicable global standards and best practices. Implement and administer the site electronic QMS (TrackWise) in conjunction with global process owners including data migration training and development of site processes/procedures. Develop monitor and report quality metrics and KPIs to site and senior leadership; lead Management Review and drive data-driven decision-making. Own the document control system for all GMP documentation (SOPs work instructions forms policies) ensuring records are current reviewed approved controlled and distributed. Interface with global stakeholders and process owners to review and integrate business-unit and global policies at the site. Maintain a secure compliant repository and ensure document retention and archival align with regulatory and company requirements. Champion data integrity (ALCOA) and compliance with 21 CFR Part 11 across paper and electronic records. Own the Deviation and CAPA programs coaching/mentoring owners approving records and ensuring timely investigation sound root cause analysis and effective closure. Own the Change Control program driving effective planning risk-based guidance across cross-functional teams SME assessments tracking implementation and on-time closure. Establishing governance processes for relevant Quality System elements to enhance oversight and drive accountability. Develop implement and maintain the site training/competency program and Learning Management System (LMS) ensuring GMP and role-based training matrix compliance for all personnel. Conduct training assessments develop training materials and coordinate onboarding recurring specialized and trend-driven retraining; maintain accurate audit-ready training records. Establish and lead the internal audit program and maintain a state of continuous inspection readiness. Support FDA state board and global audits; coordinate and author responses to observations (e.g. Form 483) and drive corrective actions to completion. Own investigations change controls assessments projects and other records for areas of responsibility. Partner with Manufacturing Quality R&D Engineering Regulatory and site leadership to resolve quality issues and foster a culture of compliance and accountability. Maintain current expertise in regulations and guidance (FDA ICH etc.) regulatory intelligence & industry trends and implementing changes as needed. Bachelors degree in Life Sciences Engineering Quality or a related field (or equivalent experience). 7 years of progressive experience in Quality Assurance / Quality Systems within an FDA-regulated environment; sterile injectable cGMP or 503B experience strongly preferred. Demonstrated ownership of multiple QMS elements (document control change control deviations CAPA training audit). Experience building and/or remediating systems in a high-growth environment preferred. Proven ability to lead teams drive continuous improvement and develop strategies that result in measurable quality enhancements. Hands-on experience in paper systems and implementing and administering an eQMS (e.g. TrackWise). Deep working knowledge of industry regulations and guidance (FDA ISO ICH EMA). Experience supporting regulatory (i.e. FDA) inspections and audits in front or back room with successful outcomes. Strong background in root cause analysis risk management and continuous improvement methodologies. Experience leading mentoring or developing others with the ability to build and lead a team as the role scope grows. Experience interfacing with Senior Leadership inclusive of effective delivery of metrics remediation plans etc. Excellent technical writing communication and cross-functional collaboration skills. Demonstrated ability to independently prioritize problem-solve and deliver results in a fast-paced environment with minimal supervision and high accountability. 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) 401k benefits with employer matching contribution Offsite team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match. 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 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 ourGlobal Candidate Privacy Statement. Required Experience: Senior Manager
About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
