QA Manager – Validation Position Available In St. Louis City, Missouri

Job Title:

QA Manager – Validation Job Description This role serves as a subject matter authority for validation quality assurance, overseeing QA validation projects and participating on project teams as a representative of the QA validation department. You will be involved in validation projects concerning equipment, instruments, facilities, utilities, processes (such as cleaning and sterilization), computer systems, and test methods, applying the validation lifecycle approach in accordance with SOPs and validation plans. Responsibilities Review and approve validation lifecycle documentation. Guide colleagues on the creation of system requirements and specifications. Coordinate with team members to ensure the quality of validation activities. Advise on the resolution of discrepancies and exceptions required for validation activities. Review and approve exceptions to protocols. Essential Skills Quality assurance and quality management system expertise. CAPA, compliance, regulatory, and audit experience. Experience in a GMP or regulated industry. Knowledge of quality systems including change control, deviations, documentation management, and training systems. Experience with electronic Quality and Training Management Systems, Quality Control, and Inspection. Additional Skills & Qualifications Bachelor’s Degree in Life Sciences preferred. Proven track record in pharmaceutical validation, QA Validation, or equivalent industry experience. Expertise in two or more of the following areas: Validation of computerized systems, software, automation, analytical instruments, utilities, manufacturing equipment, cleaning, sterilization, or test methods. Experience with validation lifecycle management and quality assessments. In-depth knowledge of industry validation standards and cGMP regulations. Ability to work autonomously and prioritize activities in a continuously evolving environment. Strong interpersonal and communication skills with the ability to positively influence others. Critical thinking and logical decision-making skills. Desire to seek process improvements that drive the best quality practices. Work Environment The team supports large-scale biological and chemistry pharma operations, making biologics used for pharmaceutical products. You will be part of a culture dedicated to impactful work, innovative thinking, and working the right way with the customer always top of mind. The organization values passion and unique contributions, offering resources and opportunities to make a difference while building an exciting career. Work involves helping customers find cures for cancer, protecting the environment, ensuring food safety, and delivering solutions for global challenges.