Commercial Quality Senior Executive

Johnson & Johnson Johnson & Johnson · Pharma · Petaling Jaya, Selangor, Malaysia

This role is for a Commercial Quality Senior Executive at Johnson & Johnson in Malaysia. The position involves leading and implementing the Quality Management System (QMS) for operations in Malaysia & Brunei, overseeing critical processes like Change Control, Non-Conformance, CAPA, and Complaint Management. The role also requires managing quality oversight for labelling, packaging, and distribution, acting as a Subject Matter Expert (SME) for audits and inspections, and ensuring compliance with J&J standards and local regulations. Experience with digital tools like SAP, Power BI, and Power Automate is mentioned, but the core function is quality management in a regulated healthcare environment.

What you'd actually do

  1. Lead site Quality Management System (QMS) establishment, implementation, maintenance, and continuous improvement for Malaysia & Brunei operations, including distribution centres.
  2. Lead and oversee Change Control, Non-Conformance (NC), CAPA, and Complaint Management processes, ensuring timely investigations, impact/risk assessments, root cause analysis, effectiveness, trend analysis, and continuous improvement.
  3. Manage quality oversight for labelling, packaging, repack/relabel operations, controlled substances, and combination products to ensure regulatory and J&J compliance.
  4. Provide quality support for new product introductions, product discontinuations, product release, temperature excursions, field actions, and trade returns.
  5. Act as Site Quality SME for audit readiness and inspection management, including regulatory inspections and internal audits.

Skills

Required

  • Big Data Management
  • Efficiency Analysis
  • Stakeholder Engagement
  • Stakeholder Management
  • Subject Matter Experts (SME) Collaboration
  • Bachelor’s degree in Science, Engineering, Pharmacy, Data Science, or related field with 4–5 years of relevant industry experience.
  • Strong knowledge of regulatory requirements, industry standards, and Quality Management Systems (QMS), preferably within a pharmaceutical environment.
  • Proven experience in audit readiness, inspection management, risk-based quality execution, and training activities.
  • Strong analytical, problem-solving, and root-cause analysis skills with a continuous improvement approach.
  • Excellent verbal and written communication skills with the ability to influence cross-functional and external partners.
  • High integrity, strong attention to detail, adaptability, and resilience in a fast-paced, highly regulated environment.

Nice to have

  • Audit Management
  • Business Behavior
  • Coaching
  • Compliance Management
  • Continuous Improvement
  • Data Analysis
  • Detail-Oriented
  • Goal Attainment
  • Internal Controls
  • Issue Escalation
  • Problem Solving
  • Process Oriented
  • Quality Control (QC)
  • Quality Management Systems (QMS)
  • Quality Standards
  • Regulatory Environment
  • MS Office
  • SAP
  • Power BI
  • Power Automate
  • Power Apps

What the JD emphasized

  • highly regulated environment