Commercial Quality Senior Executive

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Petaling Jaya, Selangor, Malaysia

Job Description:

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com

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/relabe...