MQA Manager - Biologics CDMO

Position Summary

Mauricio C. Ducassi is looking for a Manufacturing Quality Assurance (MQA) Manager to lead all activities related to daily product manufacturing and lot release. As the primary Quality contact for internal teams, the MQA Manager spearheads initiatives to resolve product, process, and material issues. Key responsibilities include directing manufacturing quality operations, overseeing in-process and final product inspections, managing batch record reviews, supporting validation efforts, and addressing customer batch release queries. The role ensures that all products consistently meet regulatory, corporate, and customer standards for quality, safety, and efficacy.

Essential Duties and Responsibilities

• Direct and manage the Manufacturing Quality Assurance activities, including on-the-floor batch record review and 24/7 Quality Assurance oversight of manufacturing processes.
• Be on call to answer quality questions from Quality Assurance and Production employees as needed.
• Provide manufacturing and Quality Assurance technical expertise to internal departments.
• Provide training on cGMPs to the QA group and Production as needed.
• Support validation report closure, change control, investigation approval, and other QA systems-related issues.
• Direct and manage strategic/global projects by collaborating with plant management groups on new products, product changes, and services to ensure a consistent approach to Quality.
• Support quality and compliance process improvements and goals using current regulations and best-demonstrated practices.
• Lead continuous quality and cost improvement efforts effectively and efficiently.
• Hire, train, and develop MQA staff, conducting performance reviews to ensure a highly effective, team-oriented workforce.
• Develop and support departmental strategic goals to uphold the highest quality standards and regulatory compliance.
• Serve as the resident QA expert in manufacturing quality assurance functions, including product release, product inspection, batch record reviews, compliance, and issue resolution on the production floor.
• Read and interpret SOPs to ensure compliance.
• Maintain up-to-date training records.
• Perform other duties as assigned.

Education and Experience

• Bachelor’s degree in Science, Chemistry, Biology, or a related field.
• Minimum of five (5) years in Quality Assurance or Regulatory Compliance Management.
• Minimum of two (2) years in a leadership role.
• Minimum of five (5) years in an aseptic/sterile product facility with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing.
• Experience working with third-party contract manufacturing in the pharmaceutical industry (strongly preferred).
• Minimum of ten (10) years of progressively greater responsibilities in the pharmaceutical products/medical services industry, including QA, Regulatory, Operations, Project, Technical, and Laboratory experience (preferred).

Supervisory Responsibilities

This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. The MQA Manager fosters a positive work environment, provides guidance and support to team members, and evaluates performance to drive continuous improvement and achieve both departmental and organizational objectives