Clinical Pharmacist: Trials & GMP Compliance Lead

QPS Holdings, LLC; Springfield (MO); On-site; USD 100,000 - 150,000; Full time

Job summary

QPS Holdings, LLC is seeking a Clinical Pharmacist to lead the pharmaceutical services team within our clinical research center. You will ensure compliance with USP guidelines, FDA requirements, and GCP standards while overseeing drug handling, formulation strategies, and SOP governance across studies.

You will collaborate with sponsors and regulatory bodies, manage budgeting, and supervise staff to advance pharmaceutical services in alignment with Sponsor directions and regulatory guidelines.

Qualifications

• Clinical research experience preferred.
• Sterile compounding and cleanroom experience preferred.
• Knowledge of FDA/GCP/ICH guidelines preferred.
• Certification / Licensure: State Registered Pharmacist.

Responsibilities

• Stay abreast of evolving USP guidelines, FDA requirements, and other relevant regulatory standards.
• Advise on drug development strategies, including formulation, stability, and regulatory submissions.
• Ongoing review, maintenance, and approval of SOPs related to pharmaceutical services.
• Potential of implementing SOPs to meet GMP standards to allow for encapsulation, labeling, etc. in accordance with Sponsor direction and regulatory guidelines.
• Potential of preparing complex compounding drugs in a fully functional USP797 pharmacy.
• Represent the pharmaceutical services department in cross-functional meetings and communicate effectively with stakeholders.
• Collaborate with external partners, including sponsors and regulatory agencies, to enhance the center's reputation and capabilities.
• Provide regular budget updates, forecasting future needs and identifying areas for optimization.
• Oversee relationships with pharmaceutical vendors, negotiating contracts, and ensuring compliance with service level agreements.
• Report any noncompliance issues to Vice President, Clinical Operations, and Investigators as soon as noticed.
• Executes clinical research trials in strict compliance with study protocol, standards of Good Clinical Practice, ICH guidelines, SOPs, QA/QC procedures, OSHA guidelines, FDA guidelines, and other regulations.
• Recruits, leads, and supervises the Pharmaceutical Services staff.

Skills

Clinical research experience

Sterile compounding

FDA/GCP/ICH guidelines

Education

State Registered Pharmacist

Job description

QPS Holdings, LLC is seeking a Clinical Pharmacist to lead the pharmaceutical services team within our clinical research center. You will ensure compliance with USP guidelines, FDA requirements, and GCP standards while overseeing drug handling, formulation strategies, and SOP governance across studies.

You will collaborate with sponsors and regulatory bodies, manage budgeting, and supervise staff to advance pharmaceutical services in alignment with Sponsor directions and regulatory guidelines.