Senior Specialist, Quality Assurance

Job Description

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.

WHAT YOU WILL DO 

This position will:

• Lead and perform internal audits (system and walkthrough) at the our Singapore site.

• Maintain current technical, compliance, regulatory, and audit skill knowledge to ensure audit program effectiveness.

• Perform audits at regional our company sites and host regional guest auditors (as applicable).

• Lead by example and apply cutting edge, risk-based audit techniques.

• Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.

• Effectively communicate audit/inspection results to stakeholders and site leaders.

• Evaluate and approve root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.

• Generate and report metrics / trends for program adherence to requirements and effectiveness.

• Perform routine risk communication for Site (Quality Council), Regional, and Divisional Management.

• Maintain Site Master Files and Manufacturing License. Lead laboratory Compliance activities. 

• Evaluate Change control (impact assessment to SMF, ML and Japan accreditation). 

• Contribute to and lead changes and improvement initiatives related to audits, inspections, and CAPA. 

• Actively participate in and contribute to the Auditor Community of Practice and Guest Auditor Program at the Divisional level.

• Take a leadership role in the Auditor Community of Practice and Guest Auditor Program. 

WHAT YOU MUST HAVE 

Qualification and Skills Requirements (Includes but are not limited to) 

Education: 

• Bachelor’s Degree in Science, Life Sciences, Pharmaceutical Sciences, or Engineering

Experience: 

• Minimum of 5 years of manufacturing. technology, laboratory, and/or quality operations experience within GMP environment. 

Expertise, Professional and Functional Competencies: 

• Understanding of Lean. 

• Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements. 

• Continuous improvement mindset. Demonstrates active skill in challenging the status quo, offering practical alternatives. Actively seeks opportunities for improving department processes and increasing efficiency. 

• Basic knowledge of scientific and technical concepts. Understands quality processes. 

• Demonstrates capability in the application of appropriate troubleshooting, root cause analysis and problem-solving techniques. 

• Project management skills. 

• Good writing (incl. technical writing) skills. 

Other Personal Attributes: 

• Learning agility – ability to continually learn new technical, quality/compliance, & regulation knowledge and apply. 

• Act with Courage and Candor - ability and willingness to advocate for compliance position with management using objective evidence. 

• Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues. 

• Collaboration – maintain productive communication channels with stakeholders. 

• Good organization and time management skills. 

• Able to work independently and with a team. 

• Meticulous with high integrity. 

• Good interpersonal and communication skills, with ability to work in cross-functional teams. 

• Positive attitude and self-motivated. 

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.  

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, 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 intellectually curious, join us—and start making your impact today.

Required Skills:

Adaptability, cGMP Regulations, Change Management, Communication, Deviation Management, Documentations, Good Automated Manufacturing Practice (GAMP), Manufacturing Quality Control, Pharmaceutical Quality Assurance, Product Disposition, Quality Assurance (QA), Quality Auditing, Quality Management Standards, Quality Standards, Regulatory Compliance, Risk Management, Self Motivation, Strategic Planning

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.