The External Site Quality Leader (ESQL) is responsible for providing Quality Oversight over one or more External Entities that manufactures or tests cell banks, biologic drug intermediates, biologic drug substances, or biologic drug products or both on behalf of our company.
Activities include the broadest possible involvement in every aspect of manufacturing and testing operations related to the quality and compliance of products produced.
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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The incumbent is responsible for all activities at the External Entity (EE) site associated with the manufacturing of our company’s products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes / methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.
This position reports to the EQA LM Platform Director, for general advice and instruction concerning Quality Operations, but functions independently.
This position also provides guidance as needed to team members in the Product Quality Manager role.
Primary responsibilities for this position include, but are not limited to, the following :
Independently manage and control all activities necessary for support of a Quality Operations program in support of External Manufacturing or Testing of Cell Banks, Biologics Drug Substance and / or Products at one or more External Entity (EE) sites.
Responsibility for oversight of an EE involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all our company’s applicable policies and procedures 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 EE Oversight Level 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.
Serves as EQA and our company’s Manufacturing Division 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 our Manufacturing Division.
Reviews all audit outcomes pertaining to the EE and ensures appropriate and timely corrective actions are identified and implemented.
Monitors efforts to improve the EE’s quality and reliability through ongoing oversight and formal communication programs and forums.
Provides support to the EE’s to facilitate and validate new product introductions.
Conducts quality due diligence assessments for pre-approval considerations of new EE’s or introduction of new products.
Develops presentations for Quality Council meetings, as requested. Provides oversight for presentation content and may support issuance of minutes.
Coordinates significant investigations including Fact Findings and product recalls as needed.
May act as the regulatory compliance liaison on our company’s behalf to interface with regulatory agencies.
Build and maintain strong relationship with External Entities, as well as our company’s 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 our Manufacturing Division and our company’s 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.
Education and Minimum Requirements :
Bachelor of Science degree, preferably in a science or engineering field with a minimum of 7 years’ relevant experience in the pharmaceutical industry and / or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
Must be competent in analyzing complex product, production and testing issues and have demonstrated scientific problem-solving capabilities.
Must have experience supporting regulatory inspections. Communicates in English, both verbally and in writing. Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships
Ability to travel up to 25% of the time.
Required Professional Competencies :
Strong interpersonal and leadership skills to communicate, collaborate and influence
High ethical standard
Ability to think End-to-End when analyzing problems and resolving project conflicts
Willingness to be flexible and to work in a rapidly changing environment
Independent and take ownership
Required Technical Competencies :
Quality Audit & External Entity Inspection Management
Deviation Management, Change Control and Batch Disposition
Quality Management System
Regulatory Standards & Compliance
Customer & Supplier Management
Quality Risk Management
Preferred Experience and Skills :
Experience with biologic and / or vaccine Quality Assurance and Quality Control
Extensive experience in Contract Manufacturing Oversight (CMOs, Labs, etc.)
Experience in biologic and / or vaccine manufacturing processes
Experience with Trackwise change control application
Experience with COMET SAP for batch disposition, deviation and CAPA management and PCR Trace
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 that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Our 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 (Weystrasse, 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.
The Weystrasse building located in the city center of Luzern is headquarter to the local and regional departments of the Animal Health Organization in Switzerland.
The site’s primary functions include Global Supply Chain Management, regional External Manufacturing and the European Finance Hub.
Who we are
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.
Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come.
We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing for Life, Impacting Lives while Inspiring Your Career Growth.