Job SummaryUnder the Head of Quality's leadership, the PIC will provide leadership and support for the development and implementation of strategic quality and operational initiatives for the company's 503B outsourcing facility in Ledgewood, NJ, to deliver business results focused on quality and compliance. The PIC position requires a high level of knowledge across aseptic manufacturing, good manufacturing practices, quality, and regulatory compliance. The PIC must maintain pharmacist licensure in good stnding in specific states and is expected to provide clinical expertise on matters with the potential to impact product safety.
Core ResponsibilitiesNOTE: Core responsibilities will be finalized based on the incumbent's expertise and the organizational needs of the company.
- QA Oversight of Production
- Complete training and remain qualified to perform all operations that the PIC oversees, including sterile garbing and gowning, compounding, aseptic filling, visual inspection, and labeling
- Perform production review of executed batch production records
- Participate in investigations related to potential or actual deviations, out-of-specification results, or other incidents related to the drug product
- Respond to internal audit findings
- PIC Licensure Responsibility
- Serve as a designated Pharmacist-in-Charge, assuming state pharmacist licensure responsibility.
- Ensure operations conducted under PIC responsibility meet all applicable legal, regulatory, and professional standards.
- Support policies, procedures, and operational practices required to maintain facility and pharmacist licensure and good standing.
- Clinical & Regulatory Compliance
- Oversight and management of Adverse Drug Event (ADE) reporting, investigation, trending, and corrective action processes.
- Ensure ADEs are handled and reported in alignment with federal, state, accrediting body, and organizational requirements.
- Assist with compliance & regulatory evaluation of and (as requested) provide clinical input on new product development opportunities.
- Regulatory Communication & Support
- Assist with regulatory communications, including drafting responses, gathering documentation, and participating in inspections or audits as assigned.
- Support regulatory inquiries, deficiency responses, and follow-up actions within the defined scope of responsibility.
- Serve as a clinical liaison during regulatory interactions when delegated.
Qualifications & Requirements- Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy (BSPharm).
- Active, unrestricted pharmacist license in good standing (state(s) as required by the organization as listed below and ability to obtain licensure in additional states as requested:
- Minimum 5-7 years of pharmacy experience, including GMP and regulatory or compliance-related responsibilities.
- Demonstrated knowledge of sterile compounding, ADE & complaint management, and controlled substance regulations.
- Experience participating in regulatory inspections, audits, or compliance investigations.
- Strong written and verbal communication skills, including regulatory correspondence.
- Familiarity with DEA, State Board of Pharmacy, accrediting organizations, and patient safety standards.
- Demonstrates sound regulatory and clinical judgment when interpreting pharmacy laws, regulations, and accreditation standards within assigned scope.
- Appropriately balances patient safety, operational realities, and compliance obligations when making recommendations or decisions.
- Understands when to escalate issues and when to act independently under delegated authority.
Pharmacist License Required - Alaska, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Nebraska, Nevada, Ohio, Oklahoma, Oregon, Texas, Virginia, and West Virginia
Pharmacist License Preferred- Alabama, Arkansas, Mississippi, Tennessee, California, and Illinois
Position Type Travel- Up to 20% as an Imprimis NJOF representative
