Distribution & Logistics Quality Manager

**Join the premier biopharmaceutical company that has been in Asia Pacific for over 60 years.**

**THE OPPORTUNITY**

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Distribution & Logistics (D&L) Quality (AP) consists of 1 Quality Manager and is managed by the Associate Director D&L Quality AP

**WHAT YOU WILL DO**

Reporting into the Associate Director D&L Quality AP, you will support to ensure that all products are handled and transported in accordance with all applicable company and regulatory requirements to meet both internal and external customer demands, the Product License, GDPs and contractual obligations.

Reports into the APCJ Regional Lead of D&L Quality, for general advice and instruction concerning Quality Operations. Receives guidance, management, and directions when necessary. Keeps the APCJ Regional Lead of D&L Quality informed on the status of operations and when challenges, opportunities and/or issues arise. Directly works with an experienced team of Quality professionals in both the internal and the external network to ensure the compliant and reliable supply of our products to our patients.
- Provides support to quality compliance oversight to ensure compliance on topics related to our global Quality Management System (QMS).
- Provides quality oversight on Distribution & Logistics (D&L) operational activities such as:

- Ensures the quality performance of assigned suppliers under D&L Quality oversight, e.g. Logistics Service Providers, Thermal Protection System (TPS) Suppliers, TPS Testing labs, Temperature Monitoring Devices suppliers
- Collaborates with internal and external stakeholders to continuously improve the performance of transportation lanes, by periodically reviewing and addressing internal and external KPIs, CAPA effectiveness and audit findings.
- Lead supplier deviation investigations within transportations, logistics & distribution.
- Manage change control requests related to D&L activities.
- Supports Internal and External Shipping Sites on the set-up and management of transportation lanes.
- Provides support to internal and external stakeholders related to GDP requirements.
- Due Diligence and collaborates with suppliers on Quality Agreement negotiation activities.
- Supports our Global Auditing Team to ensure that all required external audits are planned and scheduled.
- Supports during qualification, routine, for-cause audits of suppliers / service providers to ensure compliance with Global and Local our and applicable regulatory requirements.
- Reviews and approves CAPA plans for audit observations. Ensures that audit documentation is accurate, complete, and entered in the Audit Tracking System within the required timeframe.
- Participates in the launch and approval of thermal protection systems, including quality oversight requirements as per QMS related topic.

**WHAT YOU MUST HAVE**
- Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management or Engineering or similar.
- At least 5 years of relevant work experience in the biotech/pharmaceutical industry. Regional experience preferred.
- Expertise and broad experience in Quality Systems, Quality Assurance or a QA role within Quality Control including solid knowledge of global GMP/GDP and regulatory requirements and good documentation practices.
- Strong demonstrated interpersonal, communication, and leadership skills to work effectively across cultures on non-routine matters in challenging situations. Able to handle organizational complexity and ambiguity.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for**

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intell