Job Description

TITLE: Pharmacist in Charge (PIC)

TYPE: Direct Hire

LOCATION: Apex, NC

ONSITE/REMOTE/HYBRID: Onsite

START DATE: January 2026

The Pharmacist-in-Charge serves as the legally designated leader of the pharmacy operation, accountable for quality, compliance, and daily execution. This role acts as the clinical and regulatory anchor for the site, ensuring all processes, batch releases, and decisions align with cGMP standards, FDA 503B guidance, and North Carolina Board of Pharmacy requirements.

As a member of the startup leadership team, you will help shape how the facility operates from the outset. You will support the build-out, establish compliant systems and processes, and translate evolving regulatory requirements into practical operating standards. You will represent the organization during FDA inspections, state board reviews, and audits with confidence and credibility.

Quality systems are central to this role. You will oversee and approve SOPs, deviations, CAPAs, change controls, complaints, adverse drug event investigations, master batch records, and annual product reviews. When issues arise, you will lead investigations with clarity and discipline, ensuring corrective actions are effective and sustainable.

KEY RESPONSIBILITIES

You will maintain full accountability for pharmacy operations, quality systems, and regulatory compliance, including:

• Serving as the officially designated Pharmacist-in-Charge for the facility
• Performing final review and release of compounded sterile product batches
• Ensuring compliance with FDA 503B requirements, cGMP, USP 795, USP 797, USP 800, and all applicable state and federal regulations
• Monitoring regulatory updates and translating changes into clear operational practices
• Leading and participating in FDA inspections, state board reviews, internal audits, and customer audits
• Managing DEA-related activities, including controlled substance recordkeeping and reporting
• Obtaining and maintaining required pharmacist licensure, including non-resident licenses as needed

Quality Systems and Documentation Leadership

Quality will be central to everything you do. You will provide oversight, authorship, and approval for core quality and compliance documentation, including:

• Standard Operating Procedures (SOPs)
• Deviations, investigations, and root cause analyses
• Corrective and Preventive Actions (CAPAs) and change controls
• Customer complaints and adverse drug event investigations
• Master batch records, labeling, and annual product reviews

When problems surface, you will lead investigations with focus and follow-through, ensuring corrective actions address root causes and strengthen the operation.

How You Will Lead the Team

You will be a visible, hands-on leader who sets clear expectations and earns trust across the organization. Your leadership will include:

• Direct supervision of Quality Assurance Pharmacists and Regulatory Support personnel
• Daily oversight of compounding and production activities
• Monitoring aseptic technique, gowning practices, and cleanroom behavior
• Coaching, mentoring, and developing staff through regular feedback and one-on-one conversations
• Using operational metrics and KPIs to evaluate productivity, quality, and staffing needs

Training will be a meaningful part of your impact. You will lead aseptic technique training and support GMP, quality systems, and regulatory education across departments.

Clinical, Operational, and Startup Impact

Your clinical expertise will inform formulation decisions, manufacturing processes, and procedural design. You will work closely with cross-functional teams to support:

• New 503B product development, including technical transfer and scale-up
• Labeling, stability protocols, and product specifications
• Workflow design, documentation refinement, and early-stage operational execution
• Clinical inquiries from physicians, nurses, and other healthcare providers

During the early stages, you will take a hands-on approach, supporting operations across shifts as needed and helping establish a strong, compliant foundation for long-term growth.

QUALIFICATIONS

• Bachelor of Pharmacy or Doctor of Pharmacy degree
• Active, unrestricted North Carolina Pharmacist license or immediate eligibility
• Three to five years of experience in a 503B outsourcing facility or comparable pharmaceutical manufacturing environment
• Hands-on sterile compounding experience in a regulated setting
• Strong working knowledge of FDA 503B requirements, cGMP, DQSA, and USP standards
• Deep understanding of aseptic processes, cleanroom operations, and SOP-driven environments
• Comfort operating in a startup setting with evolving priorities and hands-on expectations

EOE STATEMENT

We are an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

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