DIRECTOR OF PHARMACY / PHARMACIST-IN-CHARGE (PIC)
Texas-Based 503B Outsourcing Facility | Confidential Search
The Company: An emerging 503B pharmaceutical outsourcing facility specializing in sterile medications for hospitals, health systems, clinics, and specialty healthcare providers. With an expanding multistate footprint and plans for nationwide growth, the organization is focused on delivering reliable pharmaceutical solutions, maintaining rigorous quality standards, and improving patient care.
This entrepreneurial organization offers an opportunity to join its senior leadership team, contribute to strategic decisions, and play an integral role in its continued expansion.
Scope of the Job
Reporting directly to the Chief Executive Officer, the Director of Pharmacy / Pharmacist-in-Charge (PIC) provides leadership and oversight of multistate pharmacy licensing, federal and state regulatory compliance, regulatory inspections, and pharmaceutical research and development initiatives.
The successful candidate will be an experienced pharmaceutical manufacturing professional with a strong background in sterile manufacturing, current Good Manufacturing Practices (cGMP), and regulatory compliance.
Initially serving as an individual contributor, the PIC will work closely with Quality and Operations leadership while helping establish the infrastructure necessary for continued growth. This position does not directly oversee manufacturing operations but plays a critical role in ensuring regulatory readiness and operational continuity.
This is a fully onsite leadership position in Texas, with relocation considered for the right candidate.
Key Responsibilities
Serve as Director of Pharmacy and designated Pharmacist-in-Charge, ensuring compliance with applicable federal and state laws, professional standards, and regulatory requirements.
Lead multistate pharmacy licensing activities, including applications, renewals, registrations, regulatory filings, and ongoing license maintenance.
Oversee FDA and DEA compliance obligations, including accurate and timely semiannual FDA product reporting.
Serve as the primary point of coordination for state Board of Pharmacy inspections, regulatory inquiries, audits, and corrective action responses in collaboration with Quality.
Support sterile and nonsterile pharmaceutical research and development initiatives, including formulation development, clinical rationale, technical documentation, and product readiness.
Collaborate with Quality and Operations leadership to maintain alignment among regulatory requirements, product specifications, process controls, and manufacturing standards.
Drive regulatory initiatives supporting new-state market entry and nationwide expansion.
Establish effective relationships with regulatory agencies and serve as a credible representative during inspections and regulatory communications.
Contribute to strategic planning, operational readiness, and organizational growth as a member of the leadership team.
Support the development of future pharmacy and regulatory personnel as business needs expand.
Candidate Requirements
Doctor of Pharmacy (PharmD) or bachelor's degree in pharmacy from an accredited institution.
Minimum five years of sterile pharmaceutical manufacturing experience involving cGMP, gained within a 503B outsourcing facility or traditional pharmaceutical manufacturing environment.
Experience limited to pharmacy compounding without qualifying sterile pharmaceutical manufacturing and cGMP exposure will not meet the requirements.
Minimum three years of management or leadership experience, including demonstrated ability to influence cross-functional teams.
Active pharmacist licensure, with multiple state licenses strongly preferred. Candidates holding a subset of required licenses may be considered with a demonstrated ability and commitment to secure additional licenses within established timelines.
Thorough understanding of FDA, DEA, state Board of Pharmacy, and pharmaceutical manufacturing regulatory requirements.
Demonstrated experience maintaining regulatory documentation, managing deadlines, and coordinating regulatory inspections.
Strong organizational, analytical, problem-solving, and written and verbal communication skills.
Familiarity with electronic batch records and pharmaceutical inventory management systems.
Ability to work independently and effectively in an entrepreneurial, growth-oriented environment.
Ability to work in fully gowned pharmaceutical production environments, including the use of respiratory protection when required.
Preferred Qualifications
Previous experience serving as a Pharmacist-in-Charge within a 503B outsourcing facility or pharmaceutical manufacturing organization.
Experience managing multistate facility and pharmacist licensing requirements.
Knowledge of sterile and nonsterile pharmaceutical formulation development.
Experience responding to FDA inspection observations, state regulatory findings, and corrective action requirements.
Demonstrated success implementing regulatory processes and supporting organizational expansion.
Leadership Attributes
The ideal candidate is a disciplined, detail-oriented regulatory leader who combines sound judgment with the ability to execute independently. This individual demonstrates accountability, regulatory expertise, and the confidence to communicate effectively with regulatory authorities and senior executives.
Success requires the ability to balance urgency with accuracy, collaborate across departments, and take ownership of compliance obligations in a rapidly developing organization.
Compensation and Location
Base Salary: $150,000–$180,000 annually.
Performance Bonus: Eligibility for up to 20%, contingent upon company performance.
Location: Texas — fully onsite; remote and hybrid arrangements are not available.
Relocation: Considered for qualified candidates.
Travel: Limited travel for industry conferences and related business activities.
Contact
Tracy Wolfe, Managing Partner
Zingaro, Fidler, Wolfe & Company
twolfe@zingaro.com
512-327-7277 | 512-785-8856