Quality Control Manager, Sterile

Описание вакансии

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, we’re 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 hims.com/about and hims.com/how-it-works . 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:

We are seeking an experienced Quality Control Manager, Sterile to join our Quality Unit at our large-scale compounding pharmacy located in New Albany, OH. The Quality Control Manager will play a critical leadership role in driving continuous improvement initiatives that ensure the highest quality products for our patients and customers. Reporting to the Director of Quality, this role will oversee quality control operations, lead in-process and final product inspections, and ensure compliance with USP standards, cGMP practices, internal SOPs, and applicable regulatory requirements.

• You Will:

+ Lead and perform in-process and post-production quality checks, including product inspection, testing, and disposition at various stages of the compounding process.

+ Manage day-to-day activities on the production floor to ensure product and raw material compliance.

+ Compile, analyze, and present trending data and quality reports to QA management.

+ Oversee investigations related to non-conformances, deviations, and customer complaints, and drive root cause analysis and corrective actions.

+ Manage the product retain program and ensure timely and compliant inspections.

+ Collaborate with production and pharmacy teams to implement quality improvement initiatives.

+ Maintain oversight of critical equipment verifications (e.g., pH meters, balances) and calibrations.

+ Review and approve compound records, Certificates of Analysis (COAs), and raw material documentation to ensure quality standards are met.

+ Draft, revise, and implement SOPs, protocols, and related documentation in alignment with USP standards and regulatory requirements.

+ Ensure ongoing compliance with USP <795,797, and 800> guidelines for sterile and non-sterile compounding and applicable cGMP practices.

+ Support internal audits and external third-party inspections.

+ Manage relationships with contract laboratories for external product testing.

+ Train and mentor pharmacy and production staff on quality standards, processes, and procedures.

+ Have a Pharmacy Technician license or be willing to obtain one within your first six months of employment (we cover costs and will help you obtain your trainee hours).

You Have:

+ Strong experience with Environmental monitoring.

+ Must have experience working in a sterile floor environment.

+ 3+ years of experience in quality control or quality assurance, must be in a sterile compounding or pharmaceutical manufacturing environment.

+ Strong working knowledge of USP <795,797, and 800> and applicable cGMP standards and making sure protocols are being followed.

+ Experience in a regulated environment (FDA 21 CFR 210/211 experience a plus).

+ Proven leadership skills with the ability to coach and develop quality and production personnel.

+ Exceptional interpersonal, verbal, and written communication skills.

+ Strong proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook); MRP system experience preferred.

+ Ability to manage multiple priorities, work independently, and maintain high attention to detail.

+ Strong technical writing skills for SOPs, protocols, and reports.

+ Familiarity with quality metrics, root cause analysis, and statistical quality control methods.

+ Proven ability to build and maintain strong cross-functional partnerships, paired with clear, effective communication across all levels of the organization.

+ Bachelor’s degree in Chemistry, Biology, Pharmacy, Quality Management, Engineering, or related discipline (preferred).

Nice to Have:

+ Experience working in a 503A or 503B compounding facility.

+ Prior management of environmental monitoring or contamination control programs.

+ Experience supporting facility expansions, FDA inspections, or operational scale-up projects.

## 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)

+ 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.

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 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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