Pharmacist in Charge (PIC)
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.
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
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, 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.
Additional Information
$10,000 Sign-On Bonus available for qualified candidates hired into this role.
Strive will reimburse costs associated with obtaining additional pharmacist licenses required for the role.