Sr. Project Manager, 503A Sterile Compounding

​​About the Role:

We are seeking a highly skilled and detail-oriented 503A Sterile Compounding New Product Introduction (NPI) Project Manager with expertise in quality assurance and regulatory compliance to oversee and manage our compounding operations. The successful candidate will be responsible for ensuring that all compounding activities are in full compliance with 503A regulations, quality standards, and industry best practices. This role requires a strong background in both project management and regulatory affairs within the pharmaceutical compounding space.

We are seeking a highly skilled and experienced Senior Compounding Project Management Subject Matter Expert (SME) to oversee and manage 503A sterile compounding operations. This individual will serve as the subject matter expert in compounding project management, ensuring all projects meet regulatory standards, quality expectations, and operational efficiency. The ideal candidate will possess deep knowledge of 503A regulations, quality assurance practices, and project management methodologies, with a proven ability to guide teams through complex regulatory environments.

As a subject matter expert, this individual will play a pivotal role in driving continuous improvement and will be the go-to resource for technical expertise related to compounding processes, regulatory compliance, and project execution.

You Will:

• Serve as the go-to subject matter expert (SME) for compounding project management, offering expert guidance to internal teams and leadership on best practices, industry standards, and regulatory compliance.
• Lead and manage 503A sterile compounding projects from inception through to completion, ensuring projects are completed on time, within scope, and in compliance with relevant regulations.
• Provide mentorship and technical leadership to project teams, ensuring effective use of resources, adherence to timelines, and the successful delivery of projects.
• Develop and maintain detailed project plans, budgets, schedules, and performance metrics, ensuring transparency and alignment across all project stakeholders.
• Anticipate and address project risks, making recommendations for mitigation strategies to ensure successful project delivery.
• Assess existing project management practices on the Compounding PMO, advising or changes and improvements to the current process
• Leverage deep technical knowledge of 503A compounding regulations and best practices to provide guidance and solve complex problems within compounding operations.
• Provide expert input on regulatory and quality issues that arise during compounding operations, helping teams navigate complex regulatory frameworks, including FDA regulations and USP <795>.
• Act as the technical resource for cross-functional teams in 503A compounding processes, advising on equipment, technology, methods, and systems.
• Stay up-to-date with evolving compounding regulations and industry standards to ensure the organization’s practices are always compliant and efficient.
• Possess a strong background in quality systems, regulatory compliance, and risk management, with hands-on experience implementing quality assurance protocols for 503A compounding operations as they relate to proper project management.
• Advise on and develop project management strategies for compounded products, ensuring compliance with industry regulations and proactively identifying potential quality risks.
• Collaborate closely with senior leadership to define project scope, goals, and deliverables that align with the organization’s strategic objectives.
• Act as a liaison between regulatory agencies, compounding teams, and management, providing timely updates on regulatory changes, quality issues, and project performance.
• Foster a culture of compliance, quality, and continuous improvement within compounding operations.
• Conduct training and knowledge-sharing sessions for teams, elevating their understanding of regulatory standards and compounding best practices.
• Drive process optimization initiatives, utilizing data and lessons learned from previous projects to streamline operations and enhance productivity.
• Implement strategies for the continuous development of compounding procedures, ensuring that 503A practices evolve to meet the highest industry standards.
• Lead root cause analysis and corrective action initiatives in response to non-conformance issues, making recommendations for process improvements to prevent recurrence.

You Have:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
• Minimum of 10 years of experience in pharmaceutical compounding, with a deep focus on 503A operations.
• Subject Matter Expert (SME) status in compounding project management, with proven expertise in managing projects across complex regulatory and operational environments.
• Strong knowledge of FDA regulations, USP <795>, and other compounding standards specific to 503A sterile facilities.
• Extensive experience in managing and optimizing compounding quality systems and ensuring compliance with regulatory standards.
• Strong understanding of project management methodologies, tools, and techniques (e.g., PMP or similar certification is preferred).
• Excellent problem-solving, organizational, and communication skills, with the ability to effectively manage multiple projects simultaneously.
• This is a remote role and requires travel up to 25% to our facilities in Ohio, Arizona, and California.

Preferred Qualifications:

• Advanced degree in a relevant field (e.g., PharmD, MS, MBA).
• Certification in Project Management (e.g., PMP).
• Previous experience in a leadership or supervisory role within compounding operations.
• Familiarity with laboratory and compounding equipment used in both 503A settings.

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.