Quality Manager - Pharmacy

Job Description

Job Description

Position Summary

we are seeking an experienced Quality Manager to lead the quality program for its sterile and nonsterile 503A compounding operations.

The Quality Manager will be responsible for building, maintaining, and continuously improving our Quality Management System while providing independent oversight of production, documentation, testing, personnel qualification, equipment, facilities, suppliers, and product release activities.

This is a critical leadership position with direct access to the Pharmacist-in-Charge and the authority to stop operations, quarantine materials or preparations, initiate investigations, and escalate quality or patient-safety concerns.

Key Responsibilities

• Lead and manage the Quality Assurance, Quality Control, and Document Control functions.

• Develop, implement, and maintain the pharmacy's Quality Management System.

• Ensure compliance with applicable requirements, including USP <795> , USP <797> , USP <800> when applicable, Florida Board of Pharmacy requirements, and relevant 503A compounding standards.

• Oversee deviations, nonconformances, CAPAs, change controls, complaints, recalls, and internal audits.

• Review and approve SOPs, controlled forms, policies, master formulation records, and quality documents.

• Ensure compounding and batch records are complete, accurate, and properly reviewed before release.

• Oversee quarantine, approval, rejection, and release controls for components and compounded preparations.

• Review environmental monitoring, personnel monitoring, sterility, endotoxin, potency, and other laboratory results as applicable.

• Coordinate investigations related to environmental excursions, testing failures, documentation errors, and process deviations.

• Oversee training, qualification, and competency records for pharmacy personnel.

• Create Primary and secondary equipment qualification protocols.

• Provide quality oversight for equipment qualification, calibration, certification, preventive maintenance, and validation activities.

• Manage supplier qualification and quality oversight of APIs, excipients, sterile components, packaging, laboratories, and service providers.

• Maintain inspection readiness and serve as the primary quality contact during regulatory inspections and client audits.

• Present quality metrics, trends, risks, and corrective-action status to the PIC and company leadership.

Supervisory Responsibilities

The Quality Manager is authorized to:

• Stop compounding, testing, dispensing, or related operations when a quality or patient- safety risk exists.

• Quarantine materials, equipment, rooms, records, or compounded preparations.

• Initiate deviations, investigations, CAPAs, change controls, supplier corrective actions, and recalls.

• Reject incomplete or noncompliant documentation.

• Require retraining or requalification of personnel.

• Recommend approval or rejection of materials and compounded preparations.

• Escalate unresolved quality concerns directly to the PIC and ownership.

Required Qualifications

• Minimum of five years of experience in compounding pharmacy, pharmaceutical manufacturing, quality assurance, laboratory quality, or another regulated healthcare or life-sciences environment.

• Minimum of two years of quality leadership or supervisory experience.

• Experience with deviations, CAPA, change control, document control, internal audits, training systems, supplier qualification, and record review.

• Working knowledge of USP <795> , USP <800> and USP <797> .

• Strong technical writing, investigation, organizational, and analytical skills.

• Ability to make independent quality decisions and challenge production when necessary.

Preferred Qualifications

• Experience in a 503A or 503B compounding pharmacy.

• Experience with both sterile and nonsterile compounding.

• Experience with USP <797> Category 3 operations.

• Experience with environmental monitoring, sterility testing, endotoxin testing, stability programs, and laboratory investigations.

• Experience preparing for Board of Pharmacy, FDA, accreditation, or client inspections.

Company Description

W3Global was established in 2006 in Fremont, CA with a vision: simplify the recruiting process and develop an industry-disrupting platform to connect candidates with clients. Our cutting-edge Applicant Tracking System enables us to find the right person for the right job, creating value for job seekers and employers. While W3Global initially focused on IT staffing, we have expanded the business to serve many other industries, including accounting and finance, legal, engineering, human resources, government and more.

We’re proud of the investments we’ve made in our team, having grown from four to 1000 employees and evolving into one of the leading recruitment and staffing solution providers in the industry. Our recruiters and account managers are passionate about connecting qualified professionals with the right positions in small, medium, and large companies.

Our Services
W3Global understands the natural ups and downs of an organization’s staffing needs. We are continuously adapting to industry and economic changes to find the right candidates.

We specialize in placing permanent, direct, contract, and temporary positions for companies of any size. Our recruiting services include sourcing, recruiting, screening, interview management, salary negotiations, training, and onboarding.

We are committed to helping organizations redefine their recruitment process by delivering our SaaS-based proprietary application tracking system software.

Our Expertise
W3Global has been delivering staffing solutions for nearly two decades; we know which recruiting strategies work best. Our expert team is committed to developing a customized solution to fit your company’s unique needs.

As a W3Global client, you’ll also receive personalized assistance from a seasoned team of staffing specialists. We are committed to providing both technical support and industry expertise to simplify the hiring process. We know that your time matters. W3Global will help you streamline the hiring process, getting it done and getting it right.

Company Description

W3Global was established in 2006 in Fremont, CA with a vision: simplify the recruiting process and develop an industry-disrupting platform to connect candidates with clients. Our cutting-edge Applicant Tracking System enables us to find the right person for the right job, creating value for job seekers and employers. While W3Global initially focused on IT staffing, we have expanded the business to serve many other industries, including accounting and finance, legal, engineering, human resources, government and more.\r\n\r\nWe’re proud of the investments we’ve made in our team, having grown from four to 1000 employees and evolving into one of the leading recruitment and staffing solution providers in the industry. Our recruiters and account managers are passionate about connecting qualified professionals with the right positions in small, medium, and large companies.\r\n\r\nOur Services\r\nW3Global understands the natural ups and downs of an organization’s staffing needs. We are continuously adapting to industry and economic changes to find the right candidates.\r\n\r\nWe specialize in placing permanent, direct, contract, and temporary positions for companies of any size. Our recruiting services include sourcing, recruiting, screening, interview management, salary negotiations, training, and onboarding.\r\n\r\nWe are committed to helping organizations redefine their recruitment process by delivering our SaaS-based proprietary application tracking system software.\r\n\r\nOur Expertise\r\nW3Global has been delivering staffing solutions for nearly two decades; we know which recruiting strategies work best. Our expert team is committed to developing a customized solution to fit your company’s unique needs.\r\n\r\nAs a W3Global client, you’ll also receive personalized assistance from a seasoned team of staffing specialists. We are committed to providing both technical support and industry expertise to simplify the hiring process. We know that your time matters. W3Global will help you streamline the hiring process, getting it done and getting it right.