Implements policies and procedures to ensure that these comply with the appropriate statutes and regulations and ensure that regulatory reporting requirements are met.  Provides expertise and guidance in interpreting USP and FDA regulations, agency guidelines, and internal policies to assure compliance.  Ensure quality system performance is measured and routinely reported to the executive management.  Assist in escorting and providing information to regulatory officials during company audits/inspections. Performs a variety of managerial tasks and duties to ensure the appropriate day-to-day operations of Quality Assurance, Quality Control, and Regulatory Affairs. Ensures activities are completed within scheduled timeframes. (i.e. regulatory submissions/reports, CAPAs, investigations, ADRs, complaint closure, etc.) Ensures adequate training (and documentation) of employees to SOPs, and Quality Assurance processes. Collaborates in the design and implementation of new products.  Ensures that products meet design specifications Works closely with labs to ensure methods and analysis are appropriate for product label claims Assist in the development of internal QC laboratory methods Develop & negotiate Quality Agreements with new and existing direct material suppliers & vendors Provide oversight for audits and visits to ensure 3rd party suppliers & vendors meet regulatory requirements Manage relationships with 3rd party Quality vendors

Bachelor’s degree or equivalent in Science or Pharmacy degree preferred.  8+ years experience in Quality Assurance with current Good Manufacturing Practices. Experience working with 503B Outsourcing facilities or pharmaceutical manufacturing is required.  Must have experience with implementing new Quality Assurance and/or Control systems & processes in a high-growth environment.  Demonstrated experience directly managing teams, including cross-functional people leadership; remote people leadership experience is a plus. Experience working in a matrix organization Willingness and ability to quickly come up to speed on quality requirements & regulations in new fields. Comfortable working in a fluid environment, and managing fluctuating priorities. Demonstrated knowledge and understanding of cGMP requirements and FDA regulations Demonstrated knowledge and understanding of the Quality System Regulations (QSR), 21CFR Parts 210,211, 11, and 820 requirements and other related regulations with emphasis on CAPA Systems. Strong communication skills with the ability to influence and drive internal & external 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   Conditions of Employment:  This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required. This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR). Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs. Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.  Outlined below is a reasonable estimate of H&H’s compensation range for this role for US-based candidates. If you're based outside of the US, your recruiter will be able to provide you with an estimated salary range for your location.The actual amount will take into account a range of factors that are considered in making compensation decisions, including but not limited to skill sets, experience and training, licensure and certifications, and location. H&H also offers a comprehensive Total Rewards package that may include an equity grant.Consult with your Recruiter during any potential screening to determine a more targeted range based on location and job-related factors.An estimate of the current salary range is$190,000—$210,000 USDWe 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 [email protected] 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.