***MUST either be a pharmacist with usp 797 compliance experience (and accreditation experience ACHC/VPP/joint Commision) OR a non-pharmacist who has extensive USP 797 compliance experience****

Objective:

Provides leadership, direction, technical expertise as well as compliance to the Pharmacy Quality Assurance Program, that will be created by the Compliance Officer, in accordance with State and Federal regulatory agencies. Ensures compliance to the portions of USP 797 that are applicable to the licensed Pharmacy locations. Actively provides guidance to multiple departments and sites regarding their compliance to Pharmacy Policies, Procedure and Regulations. Should possess pharmacy quality and regulatory experience (as it relates to USP 797) in order to provide general compliance guidance to the Pharmacy Leadership Team regarding adherence to federal and state regulatory requirements for a sterile compounding pharmacy.

Essential Duties & Responsibilities:

• Leads, develops, implements, and maintains quality strategies, procedures, and systems in line with corporate business goals. Collaborates with Pharmacy Leadership to continually improve quality systems and implements corrective actions as appropriate.

• Apply knowledge of the most current regulations to ensure Pharmacy Quality compliance. Provides necessary definition, development and deployment of the Pharmko Quality strategy (which will be created by the Compliance Officer), addressing all phases of compliance.

• Participates in the evaluation of quality events, incidents and complaints. Keeps up-to date with all related / applicable quality legislation and compliance issues. Is the quality representative for all USP-related technical questions that arise internally

• Represents the company during external inspections of Pharmacy location/s. Assists in preparation and training staff for readiness of any regulatory agency inspections and accrediting bodies.

• Liaise with suppliers to ensure appropriate qualification quality and sterility.

• Participates in the creation and amendments to Policy and Procedure documents to comply with the requirements that impact pharmacy compounding.

• Keep apprised of notices and FDA compliance policies subject to Compounding Pharmacies.

• Management of recalls originating from facilities under his/her oversight when required.

• Participation in Regulatory and customer audits at Pharmacy facilities. • Actively participate in the departmental budgeting process. • Performs other duties, special projects as assigned.

• Reporting to the CEO and Director of Pharmacy.

• Reporting capability required. IE excellent with excel, Microsoft office etc. advanced reporting capabilities preferred.

Process Management

o Plans projects and coordinates groups to effectively implement change and manage new systems.

o Assists with departmental initiatives to assure compliance with state and federal regulatory statutes as well as policy compliance.

o Assists in the development and management of pharmacy quality metrics for performance improvement of teams.

o Implements ongoing quality improvement processes working with interdepartmental teams.

Project Management

o Implement, evaluate and interpret data to predict emerging areas of need and adjust monitoring and evaluation strategies as required. o Assist in implementation and evaluation of workflow processes to assist leadership in achieving operational gains in staff efficiency and accuracy.

o Participates and leads in Pharmacy Quality meetings.

o Work with other departments to develop company-wide process improvements

Quality Management

o Assist the pharmacy leadership team in the development and management of all Pharmacy Quality related activities and develop control systems for pharmacy compounding.

o Anticipates process control problems and takes corrective action, to resolve and achieve commitments.

o Monitors deviation and investigation trends and is a signatory on the completion of RCAs and Occurrence reports.

Documentation

o Establishes and maintains policy / procedures pertaining to Pharmacy Quality documentation.

o Keeps up-to-date with all applicable legislation and compliance issues.

o Leads in the preparation of monthly and quarterly reports, data analysis and trending, including implementation of corrective actions/root cause analysis assessments as appropriate.

Authority & Accountability

• Member of the Pharmacy Leadership Team

• Management, coaching, training and leadership responsibilities • Authorization and determines product RECALL

Minimum Requirements

• PharmD

• Regulatory Experience USP 797

• Sterile compounding experience

Preferred Requirements

• Dynamic Reporting

• High level multi-tasking

• Organization

Skills and Competencies

• Extensive experience with USP 797 or otherwise willing to devote a significant amount of time and resource to become the subject matter expert.

• Strong analytical skills and leadership experience providing high quality clinical care to patients.

• Excellent problem solving, interpersonal communication and project management skills.

• Strong leadership skills that inspire team confidence and respect while motivating team members in a creative and effective manner.

• Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability.

• Must be extremely detail-oriented with respect to documentation and communication.

• Must possess Technical Review & Writing Skills, includes but is not limited to the following: Protocols, Test Methods, Corporate Policies and Quality Standards, Standard Operating Procedures, Quality Agreements, Change

Controls, Deviations, Investigations, CAPA s, ability to provide responses to any Regulatory Agency observations, etc.

• Knowledge and experience with sterile intravenous pharmacy automation, intravenous compounders and/or robotics.