Pharmacist in Charge (PIC)

Strive Compounding Pharmacy; Newberry (FL); Vor Ort; USD 145.000 - 150.000; Vollzeit

Benefits dieser Stelle

Employer-paid healthcare coverage

Choice of an FSA/HSA

401(k) plan with matching contributions

Parental leave

Free compounded meds for employees and family

Zusammenfassung

Strive Compounding Pharmacy in Newberry, Florida, seeks a Pharmacist in Charge (PIC) to manage and fortify compounding quality operations. The PIC will lead quality systems ensuring compliance with regulations like 503B and represent Strive as an authority. Applicants must have at least 10 years of experience in quality and regulatory fields, a bachelor's degree in Pharmacy, and an active pharmacist license. Competitive salary and benefits offered, including health coverage and 401(k) matching.

Qualifikationen

• 10+ years of progressive leadership experience in quality, regulatory affairs, operations, or technical oversight.
• Active, unrestricted pharmacist licensure in one or more U.S. states.
• Extensive experience leading regulatory inspections and audits.

Aufgaben

• Build a unified, scalable quality blueprint integrating operations.
• Maintain inspection-ready systems for compliance.
• Design scalable organizational structures for execution.

Kenntnisse

Expertise in quality systems

Understanding of federal and state regulations

Ability to build high-performance teams

Experience with advanced technologies

Judgment in problem-solving

Ausbildung

Bachelor's degree in Pharmacy

PharmD, MS, or MBA preferred

Jobbeschreibung

Position Summary

The Pharmacist in Charge (PIC) is responsible for fortifying 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 deep operational command with strategic leadership to ensure Strive’s quality systems are scalable, inspection‑ready, and aligned with best‑in‑class industry standards. Internally, the PIC establishes and governs a robust quality framework, drives operational excellence across compounding operations, and develops a high‑performing organization capable of sustaining rapid and compliant growth. Externally, the PIC represents Strive as a trusted national leader in 503B outsourcing, serving as the primary liaison with regulatory authorities, customers, and key stakeholders.

Location

Onsite Monday – Friday in Alachua, FL

Compensation

Salary: $145,000 – $150,000 + bonus opportunity

Responsibilities

• Build a unified, scalable quality blueprint integrating sterile and non‑sterile operations.
• Maintain inspection‑ready systems that reinforce documentation integrity and regulatory confidence.
• 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.
• 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 and concepts through the organization.
• Experience driving development of advanced technologies, principles and processes.
• Manage activities of a functional area with at least two departments or major functions.
• Responsible for cost, method, and employee results.
• Judgment in resolving complex problems based on experience.
• Represent the organization as a prime contact on projects and departmental operations.
• Interact with senior internal and external personnel on issues requiring coordination across organizational lines.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer‑centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high‑quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi‑mode communications that convey a clear understanding of unique needs of different audiences.

Preferred Experience and Qualifications

• 10+ 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, as applied to sterile and non‑sterile drug manufacturing in a 503B outsourcing facility, with practical experience implementing, maintaining, and remediating quality systems.
• Active, unrestricted pharmacist licensure in one or more U.S. states, with ability to obtain and maintain multi‑state licensure as required.
• Extensive experience leading and supporting regulatory inspections and audits, including FDA pre‑approval and routine surveillance inspections, state board of pharmacy inspections, customer audits, and third‑party quality assessments.
• Bachelor’s degree in Pharmacy or a related scientific discipline required; advanced degree preferred (e.g., PharmD, MS, MBA). Additional professional certifications or specialized training in quality, regulatory affairs, or pharmaceutical manufacturing considered a strong asset.

Benefits

• Employer‑paid healthcare coverage available after 30 days.
• Choice of an FSA/HSA.
• Parental leave.
• 401(k) plan with matching contributions.
• Weekend and holiday off.
• Free compounded meds to employees and immediate family members.

EEO Statement

Strive Pharmacy is an equal opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.