Quality Services Expert at Merck Serono SA

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

31 Jan, 26

Salary

0.0

Posted On

02 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Services, Regulatory Support, Project Management, Customer Satisfaction, GMP Guidelines, Deviation Investigation, CAPA Planning, Interpersonal Skills, Communication Skills, Collaboration, Analytical Skills, Problem Solving, Biopharma Quality Concepts, MS Office, SAP, Salesforce

Industry

Pharmaceutical Manufacturing

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 In this exciting opening within our Quality Services organization, Quality Service Expert role specializes in delivering Quality and regulatory support to key customers through all Life Science portfolio. You’ll be interacting with multiple biopharma companies that are leading this industry, to deliver quality knowledge and insight for the critical quality issues or inquiries. The role needs to closely collaborate with cross-functional teams in global, such as, Sales, Technical, Customer Excellences, Manufacturing sites, Product managers, Regulatory and other Quality functions. We are looking for bright, enthusiastic candidates who have the ambition to success in the growing biopharmaceutical industry. Ideal candidate would be a good team-player and work well under pressure. Hands on experience from biopharma Quality or Production would be preferred. What You Do Quality Services Is 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 in the form of coordinating complex customer inquiries or investigations across global sites. Possess an in-depth knowledge of company Life Sciences products and industry applications and act a Subject Matter Expert for other QS Team Members. In-depth understanding relevant regulatory guidelines (i.e., GMP) as it relates to the 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. Implements standards to ensure customer satisfaction for quality and regulatory matters for the whole Life Science portfolio. Implements policies, procedures and methods to provide quality and regulatory product and service information and continuously improves the same. Collects data in partnership with Business partner for the Commercial and Business Areas to monitor, report and improve Quality performance from a customer’s perspective. Directs the resolution of highly complex or unusual business problems applying advanced analytical thought and judgment. Applies broad industry and commercial awareness to drive financial and quality performance across Life Science business sector. Interacting with Manufacturing site, Marketing, Sales, Supply Chain, Regulatory and other Quality teams to ensure inquiries are moving forward. Assists other QS Team Members with Inquires that have stalled. Contributes / Leads internal facing relevant (quality services, operations, marketing, sales, etc.) training/ education courses Quality Complaint Resolutions Facilitate the Quality complaints from key customers across Singapore and South East Asia. F2F and online customer meetings to clarify customer's specific Quality needs and deliver pain points to the Quality Investigators. Engage with investigation letter generation with different manufacturing site Quality Investigators and ensure key customers' concerns are well addressed. Act as a local interface for APAC Quality Investigation Center. Receipt and proceed the complaint investigation process. Directs the resolution of highly complex Quality defect and issues through effective coordination of investigation process together with Quality investigation Center, site Quality and other stakeholders, such as, R&D, Product Managers, Technical experts, etc. Address customer expectations to investigation letter based on advanced analytical thought and judgment in a scientific manner. Monitor and report the Quality complaint metrics. Contribute to improve product Quality performance from a customer’s perspective. Who You Are Bachelors' in Biological Sciences (Microbiology, Biochemistry, Molecular biology, Biotechnology, etc.). Master's degree with related scientific area would be 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. Good understanding on the Biopharma Quality concepts and working knowledge of FDA and/or EMA, cGMP regulatory requirements. In-depth understanding and hands-on ability to lead the deviation, OOS investigation and CAPA planning in compliance with GMP standpoint. Strong problem solver. Ability to independently communicate and discuss complex Quality topics and regulations with customers. Strong Collaboration, Communication skills with mindfulness and empathy. Ability to work with people in cross-functional and global with diversity and inclusivity. Proficient in MS Office programs. Experience in SAP, Trackwise and Salesforce would be 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 progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

The Quality Services Expert is responsible for delivering quality and regulatory support to key customers in the Life Science portfolio, addressing quality incidents and fostering customer intimacy. This role involves coordinating complex customer inquiries and collaborating with cross-functional teams globally.