Commercial Quality Senior Executive

Job Responsibilities

Lead site Quality Management System (QMS) establishment, implementation, maintenance, and continuous improvement for Malaysia & Brunei operations, including distribution centres.

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.

Manage quality oversight for labelling, packaging, repack/relabel operations, controlled substances, and combination products to ensure regulatory and J&J compliance.

Provide quality support for new product introductions, product discontinuations, product release, temperature excursions, field actions, and trade returns.

Act as Site Quality SME for audit readiness and inspection management, including regulatory inspections and internal audits.

Establish, maintain, and govern site quality documentation, including Quality Manual, document control, records retention, and training compliance.

Lead and conduct Quality System Management Review and metrics reporting.

Lead supplier/distributor qualification and monitoring activities related to purchasing control.

Provide distributor quality oversight to ensure compliance with J&J standards and local regulations across product release/returns, storage and handling, temperature control, traceability, repack/relabel activities, controlled substances, and NC/CAPA management.

Serve as Subject Matter Expert for assigned centralised quality systems across Southeast Asia & India, supporting regional quality initiatives and projects as assigned.

Job Requirements

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 proficiency in MS Office, SAP, and digital tools; experience with Power BI, Power Automate, and Power Apps is preferred.

Ability to work independently in a matrix, multinational environment while managing multiple priorities and tight deadlines.

High integrity, strong attention to detail, adaptability, and resilience in a fast-paced, highly regulated environment.