Provides leadership, direction, technical expertise in the field of microbiology, as well as assistance with compliance to the Pharmacy Quality Assurance Program in accordance with State and Federal regulatory agencies. Ensures compliance to the portions of CFR 210/211 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 experience with quality principles as they pertain to document control and regulatory requirements in order to provide general 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 Pentec Health Pharmacy Quality strategy, 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 cGMP-related technical questions that arise internally
- Represents the company during external inspections of Pharmacy locations. 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.
- Process Management
- Plans projects and coordinates groups to effectively implement change and manage new systems.
- Assists with departmental initiatives to assure compliance with state and federal regulatory statutes as well as policy compliance.
- Assists in the development and management of pharmacy quality metrics for performance improvement of teams.
- Implements ongoing quality improvement processes working with interdepartmental teams.
- Project Management
- Implement, evaluate and interpret data to predict emerging areas of need and adjust monitoring and evaluation strategies as required.
- Assist in implementation and evaluation of work flow processes to assist leadership in achieving operational gains in staff efficiency and accuracy.
- Participates in Pharmacy Quality meetings.
- Work with other departments to develop company-wide process improvements, continue to support LeanSix Sigma initiatives.
- Quality Management
- Assist the pharmacy leadership team in the development and management of all Pharmacy Quality related activities and develop control systems for pharmacy compounding.
- Anticipates process control problems and takes corrective action, to resolve and achieve commitments.
- Monitors deviation and investigation trends and is a signatory on the completion of RCAs and Occurrence reports.
- Establishesand maintains policy / procedures pertaining to Pharmacy Quality documentation.
- Keeps up-to-date with all applicable legislation and compliance issues.
- Assists 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
- Coordination of Field Alert Reports (FAR) to FDA or any other ‘Alerts’ to any other Regulatory Agency
- Authorization of product ‘RECALL’ from any and all markets
- BS/BA degree in the pharmacy, nursing, microbiology, physical sciences or related discipline.
- Driver’s license with state minimum insurance
- Minimum 2-3 years of Quality oversight experience within a laboratory environment , with emphasis on regulated practices, monitoring and trending data and quality practices.
Skills and Competencies
- Experience with Quality and cGMP Regulations is a plus, but not required.
- 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.
- Possession of Technical Review & Writing Skills is a plus but not required, includeing but 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.
- Directors, managers and supervisors of all departments within Pentec Health.
- Renal Nutrition Leadership and Sales
- Specialty Infusion Leadership and Sales
External Contacts / Customer
- Key Opinion Leaders in Pain, Spasticity and General and Renal Nutrition
- Clinical Investigators / Research Experts in emerging therapeutic areas of interest
- Relevant Professional Associations and Societies
- Vendor and Vendor partners
- Delegation of Responsibility: In the absence of this job holder, various lower riskresponsibilities are delegated to members of the Pharmacy Quality Compliance team. All otherresponsibilities would be referred to this job holder’s immediate Superior [Director of Pharmacy Education and Clinical Integration].
Req # 2240