MSD External Site Quality Lead – Large Molecule Drug Product m/f/d 

Switzerland, Lucerne 

860841769

Job Description

We are currently seeking an Associate Director level (EQA) External site Quality Lead – Large Molecule Drug Product who will bring energy, knowledge, innovation and leadership to carry out the following:

• Responsibility for oversight of an External Entity (EE) involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the company and compliance with all governing regulations

• Responsibility for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation and deviation investigations

• Assures the development and maintenance of a Quality Agreement with the EE. Provides input into the development of contractual agreements with the EE

• Executes a program of Calibrated Quality Oversight based on the product type, capabilities, and quality and compliance performance of the EE

• Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews. This also includes providing support to build effective quality systems at the EE and supporting continuous improvement activities

• Oversees qualification and start-up activities by providing technical project management leadership and quality oversight for manufacture and testing of vaccine products

• Provides support to the EE's to facilitate and validate new product introductions

• Serves as EQA and the Manufacturing division`s subject matter expert in specific Quality systems, technology platforms, regulatory expectations and/or EE management. Utilizes this expertise to drive improved and compliant processes/systems for EQA and Manufacturing Division

• Coordinates significant investigations including Fact Findings and product recalls as needed

• May act as the regulatory compliance liaison on company`s behalf to interface with regulatory agencies

• Builds and maintains strong relationship with External Entities, as well as company operations, technology, analytical and procurement organizations

• Closely collaborates with appropriate business and functional areas to conduct Tier meetings, and Joint Steering Committee meetings (as applicable) to achieve the Manufacturing division and company objectives

• In addition to supporting the quality operations activities at the External Entity, will support the execution of Strategic Initiatives related to compliant supply, operationalizing quality and developing an engaged and capable workforce

• This role can be based in Switzerland or Ireland supporting External Entities in Europe

• Amount of Travel Required: Ability to travel up to 25% of the time

What skills you will need:

In order to excel in this role, you will more than likely have:

• At least 8years' pharmaceuticalmanufacturing experience(GMP) with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality Systems and regulatory requirements

• Aseptic manufacturing experience, experience with regulatory inspections and knowledge of multi-national regulatory agency cGMP expectations required

• Communicates easily in English both verbally and in writing

• Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships

• Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines

• Direct experience with managing external partners strongly preferred

• Familiarity with analytical assays for sterile vaccine/biologic drug product preferred

• Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ) preferred

• Quality Risk Management (QRM) Experience (e.g. Risk Lead, Facilitator) preferred

Current Contingent Workers apply

Not ApplicableNot Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:08/01/2024

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.