Pharmacist in Charge (PIC)

Location: Onsite Monday - Friday in Alachua, FL

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

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. This 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. The PIC ensures that quality systems are proactively designed, predictably executed, and continuously improved to meet evolving regulatory and business demands.

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. This leader provides executive oversight during regulatory inspections and enforcement activities, supports legal and compliance matters, and contributes subject-matter expertise to internal governance bodies, industry committees, and professional forum reinforcing Strive’s reputation for uncompromising quality, safety, and compliance.

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.

Team Leadership & Culture Building:

• 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, with 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 environment.
• Ability to integrate critical information and champion advanced strategies/concepts through the organization.
• Drives development of advanced technologies, principles and processes.
• Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees.
• Responsible for cost, method, and employee results.
• Judgement is required in resolving complex problems based on experience.
• Represents the organization as a prime contact on projects and departmental operations.
• Interacts with senior internal and external personnel on issues often 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 the 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, with demonstrated accountability for enterprise-level quality systems and compliance outcomes.
• 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 in alignment with FDA guidance and current enforcement trends.
• Active, unrestricted pharmacist licensure in one or more U.S. states, with the ability and willingness to obtain and maintain multi-state licensure as required to support national 503B operations and regulatory obligations.
• 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; proven capability in inspection readiness, response strategy, remediation planning, and sustained compliance.
• Bachelor’s degree in Pharmacy or a related scientific discipline required; advanced degree preferred (e.g., PharmD, MS, MBA, or equivalent), with additional professional certifications or specialized training in quality, regulatory affairs, or pharmaceutical manufacturing considered a strong asset.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.