Supply Operation Quality Senior Manager

Location: Hybrid role based in Shanghai, China

Company

hirify.global is a global pharmaceutical company developing and supplying medicines and healthcare products.

What you will do

• Lead quality oversight for imported products and serve as the designated DMAH Quality Responsible Person for the China market.
• Manage compliance with GMP, GDP/GSP, DMAH regulations, NMPA, SH FDA, and hirify.global quality standards.
• Oversee product testing, release, storage, distribution, labelling, packaging, third-party logistics, contract laboratories, and local repackaging operations.
• Lead QMS activities, including deviations, investigations, CAPAs, change controls, complaints, market actions, product reviews, and quality KPI monitoring.
• Coordinate audits, regulatory inspections, QRT meetings, regulatory communications, annual product reports, and APQR submissions.
• Build the SOQ team and collaborate with regulatory, supply chain, medical, commercial, legal, and manufacturing stakeholders.

Requirements

• Bachelor’s or master’s degree in pharmacy, biology, chemistry, or a related scientific discipline.
• At least 7 years of relevant pharmaceutical quality experience, including Supply Operations Quality and quality systems.
• Licensed Pharmacist qualification required for DMAH Quality Responsible Person registration with SH FDA.
• Strong experience with DMAH, GSP, GMP, GDP, audits, inspections, supplier quality, CAPA, deviations, change control, complaints, and document control.
• Fluent written and verbal English and Chinese required.
• Proven ability to lead teams, develop direct reports, influence stakeholders, and work effectively in a complex matrix organization.

Nice to have

• Master’s degree with relevant pharmaceutical experience.
• Experience managing multiple projects, strategic initiatives, quality risk management, and conflict resolution.
• Experience assessing and developing talent and influencing senior management decisions.
• Experience using generative AI tools such as ChatGPT or Microsoft Copilot responsibly to improve productivity and problem-solving.

Culture & Benefits

• Hybrid work arrangement in Shanghai.
• Cross-functional collaboration across regional, global, and China-based functions.
• Opportunities to lead strategic quality initiatives and continuous improvement programs.
• Focus on accountability, ownership, continuous learning, proactive problem-solving, and operational excellence.