Director of Operations, 503A/503B Non-Sterile Compounding
- Oversee all day-to-day operations of high-volume sterile and non-sterile compounding within 503A and 503B environments.
- Establish operational discipline that prioritizes safety, quality, and data integrity across all compounding activities.
- Collaborate daily with pharmacists and pharmacy technicians to ensure compounding accuracy, efficiency, and adherence to procedures.
- Drive and own the remediation of quality or compliance gaps, ensuring corrective and preventive actions (CAPAs) are sustainable, measurable, and verifiable.
- Lead, develop, and mentor a high-performing, cross-functional team of 100+ staff including pharmacists, technicians, supervisors, and support personnel.
- Strengthen technical and compliance capability at all levels, developing personnel of varying experience into a disciplined, quality-driven workforce.
- Foster a culture of accountability, continuous improvement, and operational excellence.
- Promote a strong quality mindset through leadership visibility, coaching, and direct ownership of performance metrics.
- Improve yield performance and reduce batch rejections through proactive process monitoring and targeted remediation efforts.
- Drive continuous improvement initiatives to enhance efficiency, throughput, compliance, and service levels.
- Develop and implement key performance indicators (KPIs) that measure operational health, quality outcomes, and regulatory compliance.
- Partner with executive leadership on growth strategy, capacity planning, and expansion efforts across 503A and 503B compounding.
- Identify and implement technology solutions to streamline workflows, enhance data capture, and increase automation where appropriate.
- Thrive in a dynamic, growth-oriented environment that demands agility and creative problem-solving.
- Lead change management efforts, piloting new initiatives and scaling successful innovations.
- Collaborate cross-functionally with Product Development, Supply Chain, Quality, and Business teams to bring operational vision to life while safeguarding compliance.
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Business Administration, Operations Management, or related field.
- 10+ years of progressive experience in pharmaceutical compounding or manufacturing operations, with direct exposure to cGMP-regulated environments.
- 5+ years of leadership experience managing large teams (100+ preferred), with proven ability to develop personnel of all levels in a compliance-driven setting.
- Deep knowledge of 503A and 503B pharmacy regulations and sterile/non-sterile compounding practices.
- Strong, hands-on knowledge of technical non-sterile dosage form production processes, including blending, compression, granulation, and preferably gummy manufacturing.
- Demonstrated success in scaling operations in a high-growth, regulated environment.
- Proven ability to work collaboratively with pharmacists and pharmacy technicians to improve technical processes, compliance, and patient safety.
- Strong track record of leading quality remediation, audit/inspection preparation, and sustainable compliance improvements.
- Advanced degree (MBA, PharmD, MS in Operations/Healthcare Management).
- Six Sigma, Lean, or other process improvement certifications.
- Experience in a start-up, high-growth healthcare, or wellness company.
- 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
Recommended Jobs
Barista
Job Description Job Description Benefits/Perks Flexible Scheduling Competitive Compensation Career Advancement Opportunities Job Summary We are seeking a friendly and outgoing Bar…
Area Supervisor
Our values start with our people, join a team that values you! Bring your talents to Ross, our leading off-price retail chain with over 2,200 stores, and a strong track record of success and growth…
Outpatient Family Medicine in Phoenix, Arizona Suburb - PSLF
Seeking a board-certified/board-eligible family medicine physician (MD or DO) with a passion for caring for the entire family. If you are interested in Loan repayment programs, this has several optio…
Telehealth Registered Dietitian
Background Cecelia Health is seeking exceptional Registered Dietitians (RDs) to join our innovative virtual specialty medical practice. We provide the training, tools, and support you need to focu…
Elevate Your Career: ACNP Observation Hospitalist
Banner Health, a Top 5 Large Health System and one of the country's premier non-profit health care networks is seeking Acute Care Nurse Practitioners to join a growing team of Hospitalists with Ban…
Part time store Personnel
Job Description Job Description Immediate opening for Yogurtini Rocky Mountain Chocolate Factory Multiple position positions. Go to { Please apply online at -opportunities Store esponsibilie…
Paver Machine Operator
Oldcastle® APG, a CRH Company, is North America’s leading provider of innovative outdoor living solutions that enable customers to Live Well Outside. The manufacturer’s portfolio of premier building …
Weekend Registered Nurse (RN
Position: Registered Nurse Reports to: Director of Nursing FLSA Classification: Non-Exempt Summary The RN plays an integral role in the success o…
Class A Owner - Operator OTR Driver
IMPORTANT UPDATE: 08/12/24. For a limited time only. We are offering the first 10 owners a ONE TIME DEAL. 92% linehaul (92/8) with only $200 deduction for cargo and liability insurance. This rate wil…