Quality Services Expert

Join to apply for the Quality Services Expert role at Merck Life Science . 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 In this exciting opening within our Quality Services organization, the Quality Service Expert role specializes in delivering Quality and regulatory support to key customers through the Life Science portfolio. You'll be interacting with multiple biopharma companies that lead this industry, to deliver quality knowledge and insight for critical quality issues or inquiries. The role requires close collaboration with cross‐functional teams in global sites, such as Sales, Technical, Customer Excellences, Manufacturing, Product Managers, Regulatory and other Quality functions. Responsible for Customer Quality and Regulatory resolution and follow‐up of Quality incidents. Foster customer intimacy and provide customers with updates to Quality complaint investigations, including face‐to‐face meetings as needed. Demonstrate expertise in project management, typically coordinating complex customer inquiries or investigations across global sites. Act as a Subject‐Matter Expert for other QS team members, possessing in‐depth knowledge of Life‐Science products and industry applications. Maintain an in‐depth understanding of relevant regulatory guidelines (i.e., GMP) as they relate to Pharma, BioPharma, IVD, Medical Devices, Food, Research Markets, etc. Deliver Quality Services, adopting a consultative approach to understand customer needs, explain our quality systems capabilities and communicate that commitment. Implement standards to ensure customer satisfaction for quality and regulatory matters for the whole Life‐Science portfolio. Apply policies, procedures and methods to provide quality and regulatory product and service information and continuously improve them. Collect data in partnership with business partners to monitor, report and improve Quality performance from a customer's perspective. Direct the resolution of highly complex or unusual business problems, applying advanced analytical thought and judgment. Use broad industry and commercial awareness to drive financial and quality performance across Life‐Science business sectors. Interact with Manufacturing, Marketing, Sales, Supply Chain, Regulatory and other Quality teams to ensure inquiries are moving forward; assist other QS team members with stalled inquiries. Contribute to and lead internal training/education courses relevant to quality services, operations, marketing, sales, etc. Quality Complaint Resolutions Facilitate the Quality complaints from key customers across Singapore and South East Asia via face‐to‐face and online meetings to clarify specific Quality needs and deliver pain points to Quality Investigators. Engage in investigation letter generation with manufacturing site quality investigators and ensure key customers' concerns are well addressed. Act as a local interface for the APAC Quality Investigation Center – receipt and progression of the complaint investigation process. Direct the resolution of highly complex Quality defects and issues through effective coordination of the investigation process with the Quality Investigation Center, site quality and other stakeholders such as R&D, Product Managers, Technical experts, etc.; address customer expectations with advanced analytical thought in a scientific manner. Monitor and report the Quality complaint metrics; contribute to improving product Quality performance from a customer's perspective. Who You Are Bachelor's in Biological Sciences (Microbiology, Biochemistry, Molecular Biology, Biotechnology, etc.). Master's degree in a related scientific area is preferred. 4–9 years of professional GMP background from pharmaceutical QC, QA or Production, with hands‐on deviation investigation experience. Certified Lead Investigator, Deviation reviewer/approver. Excellent interpersonal, verbal and written communication skills. Strong understanding of Biopharma Quality concepts and working knowledge of FDA and/or EMA cGMP regulatory requirements. In‐depth understanding and hands‐on ability to lead deviations, OOS investigations and CAPA planning in compliance with GMP. Strong problem‐solving skills; ability to communicate complex Quality topics and regulations with customers. Strong collaboration and communication skills, mindfulness and empathy. Ability to work cross‐functionally and globally with diversity and inclusivity. Proficient in MS Office; experience with SAP, Trackwise and Salesforce is an advantage. 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 progressApply now and become a part of a team that is dedicated to sparking discovery and elevating humanity#J-18808-Ljbffr