Senior Compliance Specialist (GMP)

Location: Xian, Shaanxi, China; onsite at the Xian site

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions as part of Johnson & Johnson’s global healthcare organization.

What you will do

• Execute internal audits, compliance walk-throughs, audit reporting, and findings management.
• Prepare for and support external GMP audits and inspections involving health authorities, customers, and other external groups.
• Coordinate inspection readiness activities, mock inspections, SME coaching, inspection meetings, daily summaries, and site responses.
• Identify regulatory changes, perform gap analyses, and implement Johnson & Johnson compliance standards.
• Provide compliance subject matter expertise for site personnel, quality systems, projects, investigations, complaints, and field actions.
• Track remediation plans and compliance metrics, coordinate training, lead governance meetings, and collaborate on audits and investigations.

Requirements

• Bachelor’s degree in science or a related field.
• At least five years of experience in a GMP-regulated industry, including at least one year in regulatory compliance.
• Strong knowledge of global GMP regulations and experience preparing for, managing, or supporting inspections.
• Strong analytical, communication, problem-solving, and business writing skills.
• Ability to build credibility with Quality and Compliance stakeholders and deliver against committed timelines.

Nice to have

• QA or Regulatory Affairs certification.
• Experience performing internal or external audits.
• Experience in change management and project management.
• Ability to communicate in both Chinese and English.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Collaboration with Quality, Regulatory Affairs, Operations, Product Quality Management, and other compliance groups.
• Exposure to global GMP standards, regulatory inspections, compliance benchmarking, and healthcare manufacturing operations.