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This position requires a broad experience in working in a GMP environment and fast changing environment. The QA Manager demonstrates exceptional leadership with the ability to set and drive direction of a highly diverse team. This position requires the ability to work in a cross functional leadership team and provide direction with respect to GMP compliance and business efficiency. This person requires the ability to assess the work of the team and set goals and priorities accordingly to ensure that work is completed in a compliant and most efficient manner.
Job Responsibility:
Ensure production areas receive the resources and QA support needed to maintain GMP compliance while meeting batch release timelines
Lead performance planning, goal accountability, and development for all direct reports, providing consistent coaching and mentoring
Foster collaboration between QA Project Managers and Production QA Representatives to support product transfers that meet customer expectations and regulatory requirements
Build and maintain a qualified QA production support team through strategic staffing, training, and organizational development
Drive continual improvement of the Site Quality Management System in alignment with cGMP standards (ICH Q7, ISO 9001, Food GMP) and corporate Health Care quality systems
Ensure compliance with all internal, customer, and regulatory quality commitments while supporting internal/external audits and authority inspections
Maintain and report key KPIs, lead departmental improvement initiatives—especially those focused on efficiency and digitalization—and stay current on GMP trends
Oversee development of GMP paper/electronic data systems and provide delegated backup support for the Quality Assurance Director
Requirements:
BS in chemistry, engineering, science, or equivalent experience
8+ years industrial experience in a GMP environment preferred
Extensive GMP compliance knowledge for products such as APIs, Food Additives, Excipients
Ability to apply compliance standards to production