Senior Quality Specialist

About the Role

Join Merck Life Science as a Senior Quality Specialist in Singapore, where you will play a key role in supporting high-priority quality objectives within a regulated environment such as GLP and GMP. As a principal quality expert, you will lead and execute diverse quality and compliance initiatives, ensuring alignment with global standards and delivering excellence to customers in the biotech and pharmaceutical sectors.

Primary Responsibilities

• Carry out routine quality operations for the Singapore site including various audits (data, supplier, client), manage quality management system records, and execute compliance and quality assurance tasks.
• Provide expert guidance on compliance with regulatory requirements and proactively identify and mitigate quality risks affecting business operations and customer satisfaction both locally and globally.
• Drive innovation by contributing to new quality tools, systems, and processes that enhance efficiency, reduce defects, and elevate process quality.
• Collaborate closely with internal teams such as Operations, Engineering, Supply Chain, and Project Management to embed a quality-centric culture and reinforce consistent quality strategy implementation.
• Translate customer-specific quality requirements into actionable plans to ensure timely delivery of quality solutions that exceed expectations.

Key Functions

• Lead and participate in audits, inspections, and quality/compliance activities supporting revenue-generating processes and regulatory adherence.
• Take part in reviewing and aligning documents and SOPs at a global level.
• Drive quality management processes including handling events, CAPA, change controls, effectiveness checks, and risk management efforts.
• Serve as a quality expert addressing quality-related challenges and advocate for continuous improvements to mitigate errors and reduce risks.
• Lead major customer investigations related to events, out-of-specification results, complaints, and data audits, ensuring effective CAPA implementation.
• Support and lead quality training programs and quality customer advocacy efforts targeting APAC region accounts.
• Participate in contamination control strategies and collaborate with cross-site stakeholders locally and internationally.
• Manage and lead high-priority quality projects aimed at continuous quality enhancement and operational efficiency gains.
• Engage with senior management and participate in global meetings across multiple time zones as required.

Candidate Profile

• Possess a Bachelor of Science degree in Life Sciences; advanced degrees are preferred.
• Hold certification or demonstrate significant technical expertise in a quality-related discipline supporting contract testing.
• Bring over 7 years of experience in a quality organization, with a minimum of 5 years in a cGMP/GLP environment regulated by FDA, EMA, or similar authorities within pharmaceutical, biopharmaceutical, devices, or diagnostics industries.
• Demonstrate strong skills in relationship-building, collaboration, change management, and driving quality improvements.
• Exhibit ethical responsibility, agility in implementing changes at local and global scales, and proficiency in leveraging technology to digitize and enhance quality processes.

Required Knowledge and Skills

• Fluent in both written and spoken English.
• Excellent communication and interpersonal skills for engaging both internal stakeholders and customers.
• In-depth knowledge of quality management systems applicable to global GxP environments including US, UK, Singapore, and Germany.
• Strong customer relationship management skills with experience in communicating quality and regulatory topics.
• Competent in data collection, analysis, reporting, and visualization from a quality perspective.

What We Offer

At Merck Life Science, we nourish curiosity, embrace diverse perspectives and experiences, and foster a culture of inclusion and belonging. Together, we lead the way in science and technology, empowering individuals to advance their careers at their own pace while delivering impactful innovation that benefits humanity. Join us to ignite discovery and accelerate progress!