Manager, Pharmacy and Compliance

at  SOFIE

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.

• 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.