Overview
Quality Assurance Manager Jobs in Missouri, United States at AL Solutions
Title: Quality Assurance Manager
Company: AL Solutions
Location: Missouri, United States
Mauricio Ducassi is looking for an onsite Manager of Quality Assurance for a CDMO client based on New Jersey.
About the Company: Join a fast-growing and highly respected Contract Development and Manufacturing Organization (CDMO) that partners with leading pharmaceutical and biotech companies globally. Specializing in advanced therapies, including Active Pharmaceutical Ingredients (APIs) and cell and gene therapies, this organization is renowned for its commitment to quality, compliance, and innovation.
Position Overview: We are seeking an accomplished Manager of Quality Assurance to lead the quality functions and play a pivotal role in commercializing a state-of-the-art manufacturing site. This position will drive the development and implementation of robust quality systems and compliance frameworks to support the site’s transition to full commercial production, ensuring all regulatory standards are met and maintained.
Key Responsibilities:
Develop and implement quality systems, policies, and procedures to ensure the site’s readiness for commercial manufacturing.
Lead all Quality Assurance functions, with a focus on achieving GMP, FDA, and other regulatory compliance for commercial operations.
Collaborate cross-functionally with manufacturing, process development, and regulatory teams to align quality objectives with commercial milestones.
Conduct comprehensive risk assessments and internal audits to prepare the site for commercial production.
Serve as the primary point of contact for regulatory inspections and client audits, driving successful outcomes that support commercialization goals.
Lead the pre approval inspections
Qualifications:
Bachelor’s degree in a scientific discipline; advanced degree preferred.
Significant experience in Quality Assurance within a CDMO, pharmaceutical, or biotech environment, ideally with expertise in site commercialization.
Strong knowledge of regulatory standards, including GMP, FDA, and international quality standards.
Proven leadership skills, with a background in building and guiding high-performing QA teams.
Experience leading the Pre Approval Inspections
What We Offer: This role offers an exceptional opportunity to lead a critical phase in the site’s development and commercialization journey. Our client provides competitive compensation, excellent benefits, and the chance to make a meaningful impact in a collaborative, quality-driven environment.
