TEXAS-BASED 503B OUTSOURCING FACILITY
Join the leadership team of a growing 503B outsourcing facility at a pivotal stage. Report directly to the CEO and own the licensing and regulatory strategy that opens new markets as the company expands from a multistate footprint to a national presence by the end of 2027.
A Texas-based 503B outsourcing facility supplying hospitals, health systems, clinics, infusion centers, and pharmacies with hard-to-source specialty medications. Lean, entrepreneurial, and growth-focused. Leaders carry broad responsibility and work directly with the CEO.
Seat on the leadership team, reporting to the CEO.
Direct impact: state licensure drives market entry and nationwide sales growth.
Ownership of licensing and regulatory strategy, not just administration.
Opportunity to build a team as the company grows.
The Director of Pharmacy, Pharmacist-in-Charge (PIC) leads multistate licensing, FDA and DEA compliance, regulatory inspections, and R&D support. Onsite role; individual contributor at first, partnering with Quality and Operations, without oversight of manufacturing.
Serve as PIC; ensure federal and state regulatory and licensing compliance.
Drive multistate licensing strategy: applications, renewals, nonresident registrations, reporting, and maintenance, with no lapses that delay market entry.
Oversee FDA and DEA compliance; own semiannual FDA product reporting.
Lead all state regulatory inspections and inspection readiness; direct responses to observations, deficiencies, and corrective actions with Quality.
Support sterile and nonsterile R&D: formulation, clinical rationale, documentation, manufacturability.
Partner with Operations and Quality on specifications and process controls.
Support executive leadership on strategic initiatives; occasional travel to industry events.
PharmD or bachelor’s degree in pharmacy.
Five or more years of sterile pharmaceutical manufacturing under cGMP at a 503B outsourcing facility or traditional pharmaceutical manufacturer; compounding-only experience does not qualify.
Three or more years of management experience; able to lead cross-functional work without direct reports.
Active pharmacist license in good standing; licenses in multiple states strongly preferred, with willingness to obtain additional state licenses.
Working knowledge of FDA, DEA, state board of pharmacy, cGMP, and 503B regulatory requirements.
Strong communication, organization, regulatory documentation, and problem-solving skills.
Familiarity with electronic batch records and inventory management systems.
Ability to work fully gowned, including respirator, in production labs for extended periods.
Formulation development experience.
Prior Pharmacist-in-Charge experience across a multistate license footprint.
Experience leading regulatory inspections and writing responses to FDA 483s or board observations.
Competitive base salary plus performance-based bonus.
Onsite in Texas; no remote or hybrid option.
Tracy Wolfe, Managing Partner
Zingaro, Fidler, Wolfe & Company
twolfe@zingaro.com
512-327-7277 / 512-785-8856
Zingaro, Fidler, Wolfe & Co. is recognized as a premier retained executive search consulting firm specializing in the healthcare industry. Our firm has the proven ability to successfully search and select senior-level management for our clients. Our team collectively has over 50 years of staff, line, and recruiting experience within the dental, pharmaceutical, life-science, medical device, diagnostics, and biotechnology industries.
We are unique. Zingaro, Fidler, Wolfe & Co. focuses only on the search and selection of senior management in the healthcare arena. We believe our experience and thorough knowledge of the healthcare industry provide extraordinary credentials.
Whether you are an Employer looking for a qualified applicant to join your management team or an experienced Professional seeking a new opportunity, we can assist you.
