Job Description

THE OPPORTUNITY

• Be part of the team that ensures sustainable products meets standard quality and committed to deliver to customers worldwide!
• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statistaxe2x80x99s list of Best Employers in Singapore for three consecutive years (2021, 2022, 2023).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

Our Quality 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 DOGeneral ResponsibilitiesSupports to ensure that all company products are stored, handled and transported from 3rd Party Providers (3PLs) in accordance with all applicable company and regulatory requirements to meet both internal and external customer demands, the product license, GxP (e.g. Good Distribution Practices (GDPs), Good Manufacturing Practices (GMP)) and contractual and Quality Agreement obligations.Reports into the APCJ Regional Lead of D&L Quality, for general advice and instruction concerning Quality Operations. Receives guidance, management, and directions when necessary. Keeps the APCJ Regional Lead of D&L Quality informed on the status of operations and when challenges, opportunities and/or issues arise.Directly works with an experienced team of Quality professionals in both the internal and the external network to ensure the compliant and reliable supply of our products to our patients.Core Responsibilities

• Provides support to quality compliance oversight to ensure compliance on topics related to our global Quality Management System (QMS).
• Supports to hold wholesale and import license in Singapore.
• Provides quality oversight on specific Regional Distribution Centers (RDC) and Distribution & Logistics (D&L) operational activities such as:

• Ensures that Quality of RDCs in Singapore is in state of GxP compliance and that all regulatory requirements regarding Quality, Compliance for Storage and Distribution within company scope are met, including Health Authority interactions on product and distribution Quality matters.
• Ensures the quality performance of assigned 3PLs under D&L Quality oversight, e.g. Logistics Service Providers, Thermal Protection System (TPS) Suppliers, TPS Testing labs, Temperature Monitoring Devices suppliers
• Collaborates with internal and external stakeholders to continuously improve the performance of RDCs, transportation lanes, by periodically reviewing and addressing internal and external KPIs, CAPA effectiveness and audit findings.
• Lead supplier deviation investigations within storage, transportations, logistics & distribution.
• Manage change control requests related to RDC and D&L activities.
• Supports Internal and External Shipping Sites on the set-up and management of transportation lanes.
• Provides support to internal and external stakeholders related to GDP requirements.
• Due Diligence and collaborates with suppliers on Quality Agreement negotiation activities.
• Supports Company Global Auditing Team to ensure that all required external audits are planned and scheduled.
• Supports during qualification, routine, for-cause audits of suppliers / service providers to ensure compliance with Global and Local company and applicable regulatory requirements.
• Reviews and approves CAPA plans for audit observations. Ensures that audit documentation is accurate, complete, and entered in the Audit Tracking System within the required timeframe.
• Participates in the launch and approval of thermal protection systems, including quality oversight requirements as per QMS related topic.

WHAT YOU MUST HAVEEducation Requirements

• Bachelorxe2x80x99s degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, Engineering or similar.

Required Experience and Skills

• At least 4 years of relevant work experience in the biotech/pharmaceutical industry (preferably with Distribution and Logistics environment).
• Must be locally registered pharmacist with a valid registered pharmacist license for Singapore
• Expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GDP/GMP, regulatory requirements and good documentation practices.
• Demonstrate strong problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management.
• Strong demonstrated interpersonal, communication, and leadership skills to work effectively across cultures on non-routine matters in challenging situations. Able to handle organizational complexity and ambiguity.
• Creates an inclusive working environment and is a strong collaborator, including speaking candidly.
• Fluent in English.

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Manufacturing; well-structured career path
• A state-of-the-art facility that delivers solution to its customers world-wide

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 thatxe2x80x99s committed to delivering a high quality, reliable supply to customers and patients on time, every time.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anotherxe2x80x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 12/28/2024*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.

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