Assoc. Director External Quality Assurance - D&L (Asia Pac) Job - Singapore
Ensure that all products are stored and distributed in accordance with all applicable MSD and regulatory requirements to meet both internal and external customer demands, the Product License, GDPs and contractual obligations.
Ensures the quality performance of the D&L network and external partners through direct oversight, support and technical advice, counseling to the partners' site leadership and providing on-site supervision as appropriate. This includes overseeing activities such as Partner Selection and GDP Due Diligence including establishing Quality Agreements; Quality Assurance including permanent audit readiness, tracking partner Quality metrics, providing coaching and training; Quality Control such as atypical investigations and change control requests. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities. Other primary activities include:
Reports to the External Quality Assurance Lead – D&L AP, for general advice and instruction concerning Quality Operations, but functions independently. Receives guidance, management, and direction and when necessary; executes all responsibilities independently. Keeps the EQA-D&L Lead 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 MSD's products to MSD's patients. Acts as MSD Quality point of contact for the external partner and acts as a liaison for contact and communications between the partner and internal MSD personnel in the region.
Works with Supply Chain Management and any External Partner to ensure that effective and robust Quality Systems and Quality management are in place for D&L activities. Ensures on-site guidance is available in the preparation of metrics, procedures and guidelines where warranted. Ensures proactive support in training and coaching to initiate quality improvements within Operations and Quality.
Assures the development and maintenance of a Quality Agreement with the external partners. Acts as the Quality expert on MSD's behalf regarding D&L practices and contractual negotiations. Provides input into the development of commercial contractual agreements with the external partners on quality related terms.
Executes a program of calibrated Quality oversight based on the scope of operations, product type, capabilities, and quality and compliance performance of the D&L network.
Ensures appropriate investigations are conducted by the external partners' operations into abnormal operational occurrences such as product inventory rejections, atypical events, customer complaints, temperature excursions etc. Coordinates support from appropriate staff groups and recommends corrective measures; leads in the coordination of significant investigations including Fact Findings and the coordination of product recalls as required.
Assures QO requirements on Change Requests submitted by the partners and/or MSD are appropriate and conform to all requirements.
Participates in quality due diligence assessments for pre-approval considerations of new external partners within his/her area. Ensures support to the partner in remediation of due diligence and/or pre-contract audit gaps. Supports CAPA development with partner in support of GMP audits. Ensures audit follow-up to oversee that corrective actions are implemented in a timely manner where warranted.
Monitors efforts to improve the D&L network and external partner's quality and reliability through ongoing oversight and formal metrics, communication programs and forums.
Leverages the SCM functions within the internal network to support the D&L business.
May support the regulatory compliance liaison on MSD’s behalf to interface with regulatory Agencies.
Ensures strategic and tactical collaboration with other regions, Global Logistics and central expert groups, to continuously improve MSD's effectiveness and efficiency in quality management of the D&L network.
- Bachelor degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, or Engineering;
- Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
- Must have excellent 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;
- Must have the ability to influence management of complex operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
- Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguity
- Must have exemplary people/team collaboration experience, including speaking candidly, and motivating teams.
Job: Qual Assurce - 3rd Party Manuf Job Title:Assoc. Dir, External Quality
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Microbiology, Medical, Manager, Pharmacy, Engineer, Science, Healthcare, Management, Engineering