More jobs:
Pharmacist in Charge; PIC
Job in
Gainesville, Alachua County, Florida, 32635, USA
Listed on 2026-07-10
Listing for:
Strive Pharmacy
Full Time
position Listed on 2026-07-10
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Pharmacist in Charge (PIC) – $10,000 Sign-On Bonus
Location:
Alachua, FL (Onsite Monday – Friday)
Strive Pharmacy is a personalized compounding pharmacy built on a conviction that medicine should fit the patient, not the other way around. We prioritize individualized care, clinical nuance, and genuine partnership with patients and providers.
Position SummaryThe Pharmacist in Charge (PIC) fortifies Strive’s enterprise‑wide compounding and quality infrastructure while serving as the organization’s principal external authority on 503B quality, safety, and regulatory compliance. The role blends operational command with strategic leadership to ensure scalable, inspection‑ready quality systems aligned with best‑in‑class industry standards.
Duties and Responsibilities- Quality Leadership
- Build a unified, scalable quality blueprint integrating sterile and non‑sterile operations.
- Maintain inspection‑ready systems that reinforce documentation integrity and regulatory confidence.
- Regulatory Affairs
- Provide quality subject‑matter expertise to Regulatory Affairs, Legal, and Quality teams.
- Support inspections, audits, and interactions with regulators and third‑party auditors, ensuring aligned messaging and readiness.
- Support legal and regulatory proceedings, cases, and matters requiring technical quality interpretation.
- Design scalable organizational structures and develop elite quality talent capable of high‑velocity execution.
- Implement disciplined operating systems that drive alignment, transparency, and accountability site‑wide.
- Standardize site practices, accelerate issue resolution, and improve throughput reliability across locations.
- Knowledge and Skills
- Expertise in quality systems, compounding operations, and regulatory frameworks; strong ability to translate technical concepts for colleagues.
- Deep understanding of federal and state regulatory landscapes as it pertains to 503B.
- Proven ability to build high‑performance teams and lead site execution in fast‑growth, high‑complex environments.
- Ability to integrate critical information and champion advanced strategies through the organization.
- Drive development of advanced technologies, principles, and processes.
- Manage activities of a functional area with at least two departments or major functions through managers or experienced employees; responsible for cost, method, and employee results.
- Use judgment to resolve complex problems based on experience.
- Represent the organization as a prime contact on projects and departmental operations.
- Interact with senior internal and external personnel requiring coordination across organizational lines.
- Customer focus: build strong customer relationships and deliver customer‑centric solutions.
- Optimize work processes: identify the most effective and efficient processes with a focus on continuous improvement.
- Collaborative partnership building.
- Resourcefulness in securing and deploying resources effectively and efficiently.
- Manage complexity: synthesize complex, high‑quality information to solve problems.
- Ensure accountability: hold self and others accountable to meet commitments and objectives.
- Situational adaptability: adapt approach and demeanor in real time to match shifting demands.
- Communicate effectively: develop and deliver multi‑mode communications tailored to diverse audiences.
- 4+ years of progressive leadership experience in quality, regulatory affairs, operations, or technical oversight within FDA‑regulated pharmaceutical, biologics, sterile manufacturing, or 503B outsourcing facility environments.
- Expert knowledge of FDA cGMP requirements, including 21 CFR Parts 210 and 211, applied to sterile and non‑sterile drug manufacturing in a 503B facility; practical experience implementing, maintaining, and remediating quality systems.
- Active, unrestricted pharmacist licensure in one or more U.S. states; willingness to obtain and maintain multi‑state licensure as required.
- Extensive experience leading and supporting regulatory inspections and audits: FDA pre‑approval, routine surveillance, state board of pharmacy, customer audits, and third‑party quality assessments.
- Bachelor’s degree in…
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