Job DescriptionOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide.
Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.Our Quality Assurance 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 dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.The Senior Specialist – External Quality Vaccines acts as Product Quality Manager (PQM), responsible for ensuring that all our products managed by External Quality Assurance (EQA) are manufactured, packaged, analysed, released, stored, and distributed in accordance with our expectations and all applicable regulatory requirements.
The role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Partners (EP/ExP's) manufacture and release of vaccine drug substance and drug products by means of risk-based quality oversight and on-site supervision, as appropriate.They will support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported, production volumes, number and complexity of in-markets, historical performance (production and compliance), new product or market launches, historical relationship between our company and the partner, manufacturing process complexity.
This position will report to the Quality Director or Associate Director, External Quality, for general advice and instruction concerning project, but functions independently.
The position is based in Europe.Responsibilities:Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulationsReview and approve changes to master batch recordsManage routine and complex deviations and complaints and assist in the coordination of significant investigations including Fact FindingsAssist in the coordination of any product recall involving the external manufacturerProvide support for audits of EP/ExP by ourselves and regulatory agenciesReview audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warrantedConduct routine and solve complex analytical change requests and support process modification change controlsStability Program management, including review of stability reports, and Annual Product Review assemblyProvide on-site guidance in the preparation of metrics, procedures, and guidelinesProvide proactive support in training and coaching to initiate quality improvementsTrack and monitor operational and quality performance of the EP/ExP and can work with supplier to develop Corrective and preventive action (CAPA) plansAssist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registrationResponsible for shipment under quarantineSupport routine process validation; review and approve validation reports/tech transferPrepare pre-PAI assessments, support document requests for regulatory filings and post approval changesRegular site visits to build relationships and monitor efforts to improve the external manufacturer's quality and reliability through ongoing oversight and formal communication programs and forumsQualifications and Experience:Educational background in a relevant disciplinePrevious experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including general GMP Quality Systems and regulatory requirements preferredSolves complex problems; takes a new perspective using existing solutionsWorks independently with minimal guidanceActs as a resource for colleagues with less experience within own discipline; can provide guidance on issue resolution and act as SMEMay act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides othersExplains difficult issues and works to build alignment around a complex situationAccountable for a medium project with minimal resource requirements, risk and/or complexityAbility to work across boundaries; demonstrated interpersonal, relationship building and leadership skillsCommunicates easily in English both verbally and in writingStrong knowledge of External Manufacturing management, supply chain, and operations, preferably direct experience with managing external partnersPreferred Experience and Skills:Additional languages (French, German, Italian) are an assetExperience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines.
Aseptic manufacturing experiencePrevious experience with regulatory communications such as Biologics License Applications (BLAs), New Drug Applications (NDAs)Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ)Competency in Analytical Method Validation/Verification/Transfer and Analytical StandardsQuality Risk Management (QRM) ExperienceLean Six Sigma / our Production Systems trainingTHE COMPANYOur company has had a presence in Switzerland since 1963.
With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations.
Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens).
A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world.
The new location has a target date of 2021 for operational readiness.We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.Our Tribschenstrasse office, located in the city of Luzern has a rich diversity of employees at this location including Global Supply Chain Management, Regional External Manufacturing and one of our European Finance Hubs.
The site also serves as our regional and local headquarters for our company's Animal Health Division in Switzerland.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & 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:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:05/20/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe 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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📌 Senior Specialist, External Quality (M / F / D)
🏢 Merck
📍 Madrid