Head of Pharmacy Operations

Job Description: TransMedics is the global leader in portable normothermic organ perfusion and operates the only national network for donor organ procurement in the U.S (NOP). Our clinical operation depends on tightly controlled use of pharmaceuticals and preservation solutions across every NOP clinical hubs. We are creating a new role to own procurement, control, distribution, and quality of every API and preservation solution used across our national clinical hub network — and to set the pharmacy standards the rest of the business runs to. A hands-on, high-autonomy role for a senior pharmacist who has run licensed operations at scale and wants to build a national program, not manage a single site. What you will do Licensure and PIC oversight Serve as Pharmacist-in-Charge, Designated Representative, or Responsible Person for TransMedics’ main and clinical hub pharmacies, wholesale distributor, and 3PL licenses. Own multistate licensing end to end — resident and non-resident pharmacy, wholesale distributor, 3PL, and controlled-substance registrations for every TMDX clinical hub and every ship-to state, including renewals, changes of ownership, and inspection follow-up. Lead NABP, drug distributor accreditation, and state board inspection readiness, and act as our primary point of contact during inspections and audits. Pharmacy operations across the hub network Partner with Supply Chain to establish remote controlled pharmaceutical and solution dispensing systems across TransMedics' clinical hubs to maintain highest level of quality control and tracking. Define and maintain SOPs for receipt, verification, storage, pick/pack, dispensing, shipping, returns, recalls, and destruction of prescription drugs at every hub. Set cold-chain and environmental-monitoring standards for temperature-sensitive and specialty products, including excursion evaluation and product disposition. Set controlled-substance standards to DEA requirements: CSOS ordering, receipt, secure storage, inventory reconciliation, suspicious-order monitoring, theft/loss reporting, and reverse distribution. Drive DSCSA compliance network-wide — serialization, transaction data, trading-partner verification, and suspect/illegitimate product investigations. Assess each hub, on-site on a regular cadence and address any deficiencies to successful closure Compliance, risk, and quality Build and run the pharmacy compliance program — risk assessments, monitoring, internal audits, deviations, CAPAs — with reporting to executive leadership and the board-level compliance committee. Partner with Quality and Regulatory Affairs to align pharmacy SOPs with the company QMS (21 CFR Part 820 / ISO 13485 for device operations; applicable cGDP expectations for drug distribution). Track evolving federal and state pharmacy, wholesale, and controlled-substance regulations and translate them into operational requirements and training. Lead pharmacy-related investigations, recalls, and field actions with Quality, Legal, and manufacturers. Cross-functional leadership and growth Act as pharmacy SME for new hub openings, product development and launches (including drug-device combination products), payer and manufacturer contracting, and technology selection (pharmacy management, inventory, serialization, temperature monitoring). Build and deliver pharmacy training and competency programs for hub technicians and warehouse staff. Represent the company with state boards, NABP, trade associations, manufacturers, and key customers on pharmacy practice matters. Mentor pharmacists and technicians across the network and shape the future pharmacy organization as we scale. What you bring Minimum Qualifications PharmD or BS in Pharmacy from an ACPE-accredited program. Active, unrestricted U.S. pharmacist license in at least one state, and willingness to obtain additional state licenses in your first 12 months. 8+ years of pharmacy practice, including 3+ years as Pharmac…

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