Manager, Pharmacy Compliance at SOFIE

Job Description | Manager, Pharmacy Compliance
Title | Manager, Pharmacy Compliance
Department | Quality/Compliance
Reports To | Director, Pharmacy Compliance

Remote role 

Overview
SOFIE aseptically manufactures and dispenses therapeutic and diagnostic radiopharmaceuticals across the US and is
committed to all aspects of Quality and Compliance in the manufacture of these products. The successful candidate will
play an active and integral part of the Quality, Pharmacy, and Radiation Compliance team. The applicant will be responsible
for compliance oversight of the SOFIE network, for ensuring continuous process improvements and supporting the current
pharmacy program. In addition, create and implement new processes required for pharmacy compliance. The candidate
must be strong at organization, communication, interpretation of regulations, and writing skills. This position reports directly
to the Director, Pharmacy Compliance.

Essential Duties and Responsibilities

▪ Assist the Director, Pharmacy Compliance in ensuring compliance with <825> regulations, and state pharmacy laws and regulations.

▪ Establish a BOP approved employer-based pharmacy technician training program.

▪ Collaborate with other SOFIE departments to support the pharmacy training program.

▪ Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.

▪ Perform pharmacy compliance audits and assist sites in internal or external audits, as well as corrective actions to any deficiencies found.

▪ Staying current, researching and monitoring rules and regulations (BOP, USP, and other state regulatory agencies).

▪ Disseminating regulatory information and current regulations to others within the organization.

▪ Reviewing the organization for compliance problems and providing input on change controls.

▪ Acting as a liaison with government regulatory agencies.

▪ Assisting with or issuing regulatory responses

▪ Attend Board of Pharmacy meetings, as required.

▪ Write and review standard operating procedures (SOPs) as required.

▪ Writing and training staff on regulatory procedures.

▪ Assist with licensing as needed.

▪ Collaborate with Manager, Pharmacy Licensing and Complaints as needed for license renewals and new applications.

▪ Providing status updates as required to management.

▪ Support SOFIE’s compliance with HIPAA regulations.

▪ Other responsibilities as required by the Director, Pharmacy Compliance.

Qualifications
▪ Bachelor’s degree in science, technical, or legal studies.
▪ PharmD. Preferred.
▪ Pharmacy technician experience preferred.
▪ Experience in quality or regulatory affairs and/or pharmacy (minimum 3 years preferred).
▪ Knowledge of USP and BOP regulations.
▪ Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work
independently with limited supervision required.
▪ Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, and regulatory
agencies required.
▪ Ability to prepare and present written and verbal reports to upper management required.
▪ Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or
technical procedures required.
▪ Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure
manuals required.
▪ Ability to write reports, business correspondences, complete applications, and procedures required.

▪Ability to effectively present information, deliver training, and respond to questions from groups of colleagues,
managers, partners, and customers required.
▪ Ability to demonstrate critical thinking required.
▪ Ability to manage multiple projects and deadlines.
▪ Ability to work independently on tasks.
▪ Proficient in MS Office applications required.
▪ Travel: up to 40% domestically.