Quality Manager

Job Title: Quality ManagerJob Description 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. Responsibilities 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. Essential Skills 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. Additional Skills & Qualifications 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. Work Environment The position is based in a 503B compounding facility equipped with cleanrooms. The work schedule is Monday through Friday. Job Type & Location This is a Permanent position based out of Hoover, AL. Pay and Benefits The pay range for this position is $110000.00 – $140000.00/yr. Competitive benefits offered by the company Workplace Type This is a fully onsite position in Hoover,AL. Application Deadline This position is anticipated to close on Aug 25, 2026. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr