The Quality Manager is entrusted with the critical role of overseeing and maintaining quality assurance (QA) and quality control (QC) programs within a 503B outsourcing facility. This position is integral to ensuring compliance with FDA, cGMP (Current Good Manufacturing Practices), USP , USP , and DEA regulations, thereby guaranteeing product safety, efficacy, and sterility. The Quality Manager will lead audits, manage investigations, and spearhead continuous improvement initiatives.

• Ensure compliance with FDA 21 CFR Part 210 & 211, USP , USP , and cGMP requirements.
• Demonstrate proficiency and adherence to Standard Operating Procedures related to sterile compounding, cleanroom operations, and quality control.
• Develop and implement quality assurance procedures for compounded medication, including materials, storage, preparation, and dispensing.
• Supervise environmental monitoring, sterility, endotoxin, and particulate testing to ensure product safety.
• Coordinate internal audits, supplier audits, and regulatory inspections, responding to findings with appropriate action plans.
• Oversee QA/QC functions performed by compounding and quality personnel, ensuring proper documentation of all tasks.
• Collaborate with Departmental Managers to assist with personnel training and compounding validations, including scheduling, completing, and documenting Aseptic Process Simulations and training plans.
• Manage quality risk, deviation investigations, CAPAs, and change controls.
• Work with Department Managers to evaluate patient complaints and adverse events, ensuring appropriate investigations and resolutions.
• Maintain facility and equipment requirements, including certifications, audits, calibrations, and maintenance scheduling.
• Ensure validation of equipment, processes, and analytical methods used in production.
• Communicate, document, and follow up with third-party laboratories regarding product testing and environmental sampling.
• Review and approve batch records, certificates of analysis, and release specifications.
• Assist with recalls of medications when applicable.
• Support inspections by the board of pharmacy, FDA, and accreditation bodies.
• Lead and train cross-functional teams on cGMP, aseptic techniques, and contamination control.
• Act as a liaison between quality, production, and regulatory teams to maintain compliance.
• Drive continuous improvement initiatives to enhance efficiency, product quality, and regulatory readiness.

• Degree in Quality Assurance, Science, Medical Sciences, Pharmacology, or an equivalent combination of education and experience.
• Minimum of 3 years in Quality Management, Quality Assurance, or related field.
• In-depth knowledge and experience with FDA regulations and cGMP standards 21 CFR 210 and 211.
• Strong understanding of quality management principles and procedures.
• Proficiency in quality systems, CAPA management, and data-driven decision making.
• Strong verbal and written communication skills.
• Ability to develop and maintain collaborative relationships across the organization.
• Self-motivated with critical attention to detail, deadlines, and reporting.
• Exceptional work ethic.

• Experience in pharmacy compounding or pharma manufacturing preferred.
• Experience with Master Control Quality Management Software is preferred.
• Thorough knowledge of FDA regulations, including 21 CFR Parts 210 and 211.
• Strong understanding of CAPA programs, deviation investigations, and change control processes.
• Experience with environmental monitoring, sterility assurance, validation, and contamination control programs.
• Ability to analyze data, identify trends, and make risk-based quality decisions.
• Strong organizational, problem-solving, and project management abilities.
• Ability to build collaborative relationships across departments and with external partners.
• Ability to thrive in a fast-paced, highly regulated environment.
• Demonstrated commitment to quality, compliance, and continuous improvement.

The position is based in a 503B compounding facility equipped with cleanrooms. The work schedule is Monday through Friday.

This is a Permanent position based out of Hoover, AL.

The pay range for this position is $110000.00 - $140000.00/yr.

Competitive benefits offered by the company

This is a fully onsite position i