Senior Manager, Quality Systems

About 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 builder’s 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. You Will: 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. You Have: Bachelor’s 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. 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) 401(k) benefits with employer matching contribution Off‑site team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're 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 View email address on click.appcast.io 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. 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