Merck Group

Senior Quality Specialist

Merck Group  •  Singapore, SG (Onsite)  •  15 days ago
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Job Description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

We are a leading science and technology company. Our life science business offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.

Scope of Responsibility: Performs a Principal Quality expert role within a regulated environment e.g. GLP/GMP, leading high priority quality objectives/projects, performing a wide range of routine quality operational activities to support the business, leading/supporting key compliance, quality operational & targeted customer activities (may include global). Interacts with key internal & external stakeholders to ensure alignment and focus on global quality standards/initiatives.

What You Do

As a seasoned Quality professional, you will be instrumental in performing a wide scope of routine Quality & Compliance activities for the Singapore site in addition to driving and executing priority quality initiatives that may have both local and/or global impact to the business and/or customers. Your primary responsibilities will include:

  • Quality Operations Execution: Perform routine quality activities to support the Singapore business including auditing (data, supplier, client etc), QMS record management/review & other essential compliance & Quality Assurance activities.
  • Compliance and Risk Mitigation: Provide expert support and ensure adherence to relevant compliance requirements, quality standards, and industry regulations. Proactively identify and mitigate quality risks that could impact customer satisfaction or business operations at the local but also global level where applicable
  • Innovation and Continuous Improvement: Contribute to the development and implementation of future-focused quality tools, systems, and methodologies aimed at enhancing operational efficiency, reducing defects, and improving process quality.
  • Cross-Functional Collaboration: Partner with internal stakeholders—including Operations, Engineering, Supply Chain, and Project management—to promote a quality-centric culture and ensure consistent execution of quality strategies across the business.
  • Customer-Focused Quality Initiatives: Help translate customer-specific requirements into actionable quality plans and programs where required, ensuring timely delivery of solutions that meet or exceed expectations.

Essential Job Functions:

  • Conduct key activities supporting revenue generating work such as data auditing, and key quality/compliance activities such as internal/process inspections, supplier audits, client audits, regulatory onsite inspections, QAGs etc.
  • Active participation in document and SOP reviews driving global alignment where necessary
  • Lead/support activities on quality management systems and processes including events, CAPA, effectiveness checks, change controls, risk management etc
  • Act as a quality expert for quality related issues
  • Support global Quality Improvement with key improvement initiatives that mitigate potential errors & strengthen risk avoidance
  • Help drive the timely conduct of major customer investigations from events, OOS, complaints and/or data audits, as well as drive effective implementation of key CAPA with significant customer impact
  • Support/lead local and global quality training programs as required
  • Support Quality Customer Advocacy (customer support) where customer quality expectations are needed for targeted accounts in the APAC region.
  • Help drive identification of potential site quality risks, reinforcing best practices, and aligning internal operational stakeholders in mitigation & remediation
  • Liaise with other key stakeholders in effective contamination control strategy (CCS) both locally and across other CTS sites where required
  • Collaborate across different geographies (US, UK, SNG, DEU) and proactively seek support from key stakeholders to obtain the required input and alignment with key high priority quality-based objectives
  • Lead quality focused high priority quality projects/initiatives as directed to drive continuous improvement or increase efficiencies
  • Participate in or lead other activities as required by Senior Management. This will involve participation in meetings across different time zones.

Who You Are

Education and Experience:

  • Minimum of a B.S. in the Life Sciences, advanced degree preferred.
  • Certification or high level of technical quality expertise in a Quality related area supporting contract testing
  • 7+ years' experience within a Quality organization
  • 5+ years working in a cGMP/GLP environment/FDA/EMA regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics and a track record of quality improvement and support of customers in a services environment.
  • Strong relationship building and collaboration, the ability to drive and manage change.

Competencies:

  • Acts ethically and takes responsibility for quality of own work
  • Collaborates with various local and global teams to identify and implement improvements that add value to customers
  • Track record in dealing with customers within a GMP/GLP environment
  • Works with agility, drives, and implements changes on local and/or global scales.
  • Applies technology to drive digitalization, improve quality, and increase the value of customer service offerings.

Knowledge and Skills:

  • Fluent in both written and spoken English.
  • Excellent communication & interpersonal skills (internal & external)
  • Excellent working knowledge of applying QMS in a US/UK/SNG/DER GxP environment
  • Strong proficiency in customer communication and relationship management skills, including effective communication techniques.
  • Proficient in collecting, analyzing, and reporting quality data, using data visualization tools, and ability to advocate, from a quality impact perspective, for the customer within the organization
  • Direct experience in communicating with customers on quality & regulatory topics

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Merck Group

About Merck Group

This channel is not intended for U.S. and Canadian visitors. Merck operates in the U.S. and Canada as EMD Serono in Healthcare, MilliporeSigma in Life Science and EMD Electronics in Electronics. An unaffiliated and unrelated company, Merck & Co., Inc., Kenilworth, NJ, US holds the rights in the trademark MERCK in the U.S. and Canada.

_______________________________

We are Merck, a leading global science and technology company headquartered in Germany.

We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics.

Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet.

We believe in the positive power of science and technology. It has determined our actions since 1668 and inspires us to continue researching for a future worth living. As a family-owned company with over 350 years of experience, we stand for sustainability, responsibility, and innovative strength.

We take pride in being a diverse and inclusive company that values and fosters the talents and abilities of our employees. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Work your Magic and join Merck.

Legal Disclaimer: www.merckgroup.com/en/legal-disclaimer.html

Data Privacy Declaration: www.merckgroup.com/en/privacy-statement

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Darmstadt, DE
Year Founded
Unknown
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