Sr. Manager Global Regulatory Compliance

Shanghai, China ( Hybrid )

Full Time

What you will do

The Senior Manager, Global Regulatory Compliance (GRC), is responsible for maintaining sustainable compliance programs that are aligned with Client Regulatory Compliance processes, as well as segment and franchise requirements. This role will provide cGMP compliance insight for key operational activities regulated by local Health authorities, and other relevant regulatory bodies. This role will work closely with site quality, compliance, operations, and technical operations leadership to cultivate GMP awareness, issue identification, risk mitigation, inspection readiness, and BOH management. This role will have responsibility for maintaining relationships through interdependent partnering and forming alliances with cross functional business partners to drive compliant completion of key goals and objectives. This position will primarily support the Client businesses within China, and other APAC markets as appropriate

Key Responsibilities

• Lead regulatory compliance and quality risk management activities across assigned sites, proactively identifying, assessing, and escalating compliance risks to leadership.
• Monitor compliance performance through data analysis, quality records reviews, audits, inspections, investigations, CAPAs, complaints, and regulatory communications.
• Drive timely resolution of compliance issues by partnering with site teams on corrective and preventive actions (CAPAs), risk mitigation plans, and continuous improvement initiatives.
• Provide expert guidance on cGMP requirements, regulatory expectations, quality systems, and critical quality or regulatory compliance matters.
• Support Health Authority inspections and audits by preparing sites, facilitating inspection readiness, managing responses, and overseeing post-inspection commitments.
• Collaborate with site leaders, process owners, and cross-functional stakeholders to ensure compliance considerations are embedded in product lifecycle management, supply chain projects, and quality system changes.
• Maintain alignment of site policies and standards with corporate requirements while providing insight into new and emerging regulatory expectations across the APAC region.
• Participate in governance forums, crisis management, and enterprise compliance programs to strengthen risk management, drive strategic consistency, and promote a culture of quality and compliance.

What We Are Looking For

Required Qualifications

• Bachelor’s degree required; advanced degree preferred, ideally in Science, Engineering, or a related technical discipline.
• Minimum 8 years of experience in Quality, Compliance, Manufacturing, or Operations within the pharmaceutical, medical device, or cosmetic industries; China experience strongly preferred.
• Strong knowledge of APAC and Chinese GxP regulations, GMP requirements, and regulated manufacturing environments.
• Experience supporting regulatory inspections, responding to Health Authority observations, and managing compliance within quality systems.
• Proven ability to analyze data, manage complex projects, and operate effectively in global and multicultural environments.

Who Are You?

• A strategic and independent problem solver who can assess risks, make sound decisions, and drive solutions in complex business environments.
• A strong leader and collaborator with the ability to influence, negotiate, and build trusted relationships across cross-functional teams.
• An effective communicator who can translate complex technical and regulatory information into clear business recommendations; fluent in both English and Chinese.
• A change agent who can navigate resistance, foster alignment, and lead stakeholders through regulatory and quality initiatives.
• A results-driven professional with strong organizational skills and proficiency in MS Office tools, analytics, and presentation software.