M&S-China EM&S QA Manager-Shanghai

Location: Shanghai, China

Company

hirify.global is a global healthcare company focused on developing and delivering medicines through science and innovation.

What you will do

• Provide on-site production and quality supervision at contract manufacturing organizations, including incoming quality control and cross-contamination risk management.
• Act as the liaison between the MAH quality organization and external CMOs, maintaining communication and responding to potential quality or supply-chain issues.
• Supervise sampling and analysis of key materials, intermediates, and finished products, while ensuring contract laboratory compliance.
• Review batch analysis records, batch production records, deviations, and OOS investigations before product release.
• Manage validation documents, deviations, change controls, CAPA, product complaints, recalls, PQRs, and long-term stability OOS results.
• Support CMO and supplier audits, self-inspections, regulatory actions, and continuous improvement activities.

Requirements

• Master’s degree or higher in Pharmacy, Chemistry, Biology, Biochemistry, or a related field.
• At least 5 years of experience in pharmaceutical production and quality management, including at least 3 years in sterile drug production and quality management.
• Experience with pharmaceutical process control and quality inspection; MAH system experience is preferred.
• Knowledge of NMPA and EMA GMP regulations, ICH guidelines, MAH requirements, and biological product quality and production processes.
• Strong inspection management, analytical, problem-solving, judgment, communication, coordination, execution, and resilience skills.
• Good English skills are required.

Culture & Benefits

• Supportive, future-focused international healthcare environment.
• Opportunities for career growth through promotions and lateral moves.
• Rewards package recognizing individual contribution.
• Healthcare, prevention, and wellness benefits for employees and families.
• At least 14 weeks of gender-neutral parental leave.