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 Pharmacist-in-Charge (or equivalent) in specialty, mail-order, central-fill, wholesale distribution, 3PL, or health-system operations. Hands-on experience with multistate licensure, board of pharmacy inspections, and DEA compliance for Schedule II–V products. Working knowledge of DSCSA, cold-chain and USP / storage and distribution standards, and NABP drug distributor accreditation. Track record authoring SOPs, leading audits or inspections, and managing CAPA in a regulated environment. Strong communicator — able to brief non-pharmacist executives and represent the company with regulators. Willingness to travel ~25% to clinical hubs and headquarters. Preferred
Qualifications:
Experience in a medical device or drug-device combination product company, or within an FDA-registered QMS.Experience opening or licensing new pharmacy or distribution sites from greenfield. Familiarity with 340B, specialty pharmacy accreditation (URAC, ACHC), or manufacturer limited-distribution networks. Board certification (BCPS, BCSCP) or credentials in regulatory affairs or quality (RAC, CQA).Experience selecting or implementing pharmacy management, serialization, or environmental-monitoring systems. As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary. Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $159,900.00-$227,550, which represents the company's current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history. Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K PlanPet insurance Employee Stock Purchase PlanTransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
Summary
Location: Andover, MA
Type: Full time
