Quality Control Manager, Sterile

Hims & Hers • Gilbert, AZ

2d

About The Position

We are seeking an experienced Quality Control Manager to join our Quality Unit at our large-scale compounding pharmacy located in Gilbert, AZ. 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.

Requirements

• Strong experience with Environmental monitoring.
• Must have experience working in a sterile floor environment.
• 3+ years of experience in quality control or quality assurance, ideally in a non-sterile and 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 Haves

• 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.

Responsibilities

• 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).

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees