Quality Manager

Job Description

Job Description

Description

The Quality Manager is responsible for overseeing and maintaining the quality assurance (QA) and quality control (QC) programs in a 503B outsourcing facility. This role ensures compliance with FDA, cGMP (Current Good Manufacturing Practices), USP <797> , USP <800> , and DEA regulations. The Quality Manager will lead audits, manage investigations, and drive continuous improvement initiatives to uphold product safety, efficacy, and sterility

Job Activities and Responsibilities:

Ensure compliance with FDA 21 CFR Part 210 & 211, USP <797> , USP <800> , and cGMP requirements.

Demonstrate proficiency and follow Standard Operating Procedures related to sterile compounding, cleanroom operations and quality control.

Develop and implement quality assurance procedures to ensure the quality of compounded medication, including but not limited to the materials, storage, preparation, and dispensing of compounded medication.

Supervise environmental monitoring (EM), 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 to ensure that procedures are followed and that all QA/QC tasks are properly documented.

Work directly with Departmental Managers to assist with personnel training and compounding validations, including but not limited to scheduling, completing, and documenting all initial and ongoing Aseptic Process Simulations (APS), personnel skill assessments, didactic evaluations, and training plans.

Oversee quality risk management, deviation investigations, CAPAs (Corrective and Preventive Actions), and change controls

Work with Department Managers to evaluate patient complaints and adverse events, ensuring appropriate investigations and resolution.

Oversees and maintains facility and equipment requirements, including but not limited to annual and biannual room certifications, monthly audits, equipment certifications, calibrations, and maintenance, and coordinates scheduling with Departmental Managers.

Ensure proper validation of equipment, processes, and analytical methods used in production.

Directly responsible for communication, documentation, and follow up with third-party laboratories regarding product testing, environmental sampling, and ongoing quality and stability study projects.

Review and approve batch records, certificates of analysis (COAs), and release specifications

Assist Departmental Managers with recalls of medications when applicable.

Assist General Manager/Operations Manager with board of pharmacy, FDA, and accreditation inspections.

Other duties as determined by General Manager and RPC QARA management.

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 and resolve quality-related issues.

Drive continuous improvement initiatives to enhance efficiency, product quality, and regulatory readiness

Other duties as determined by the General Manager

Qualifications and Education Requirements

Bachelor’s degree in Quality Assurance, Science, Medical Sciences, Pharmacology, etc., or an equivalent combination of education and experience is required

A minimum of 3 years in a Quality Management, Quality Assurance, or related field

Experience in pharmacy compounding or pharma manufacturing preferred

In-depth knowledge and experience on FDA and applicable laws and regulations, as they relate to the industry, as well as of 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 (including analysis, interpretation, and reasoning)

Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external stakeholders

Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment

Self-motivated with critical attention to detail, deadlines, and reporting

Exceptional work ethic

Skills

Gmp, Capa, Audit, Fda, Cgmp, Pharmaceutical, Sop

Top Skills Details

Gmp,Capa,Audit,Fda

Additional Skills & Qualifications

Knowledge, Skills & Abilities

Thorough knowledge of FDA regulations, including 21 CFR Parts 210 and 211.

Strong understanding of quality management systems, 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.

Excellent verbal and written communication skills.

Strong organizational, problem-solving, and project management abilities.

Ability to build collaborative relationships across departments and with external partners.

Self-motivated with exceptional attention to detail and strong follow-through.

Ability to thrive in a fast-paced, highly regulated environment.

Demonstrated commitment to quality, compliance, and continuous improvement.

Experience Level

Intermediate Level

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 in Hoover,AL.

This position is anticipated to close on Aug 7, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [email protected] 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.