Director, Quality - hims & hers

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 Quality Assurance will be responsible for developing, implementing, evaluating, and maintaining the site Quality systems and leadership of the site's Quality Assurance & Control systems. They will report to the SVP of Pharmacy Safety, Quality, and Compliance. They will ensure the organization's internally compounded products meet the quality, integrity, and efficacy standards set by the organization. They are a member of the site leadership who, in partnership with Operations leadership, will champion the creation of a Quality culture that embodies Quality by Design and Continuous Improvement expectations. Directs all Quality aspects of the company's compounding sites. Interacted with other leadership team members to help set policies and guide adherence to them, as well as any applicable state and federal standards from the boards of pharmacy, USP, and FDA. Responsible for the decision on approval and release of all compounded products. Organizational responsibilities include site Quality Assurance, Quality Control documentation, and regulatory inspection activities. Additional responsibilities include managing the Quality department budget, hiring and developing Quality personnel, performing employee appraisals/competency evaluations, and managing the Quality organization.
You Will:

• 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

You Have:

• 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 USD

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.

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