Job Detail

JOB DESCRIPTION

Job Description

An amazing opportunity has arisen for an External Site Quality Lead.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Responsibility for oversight of an External Entity involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable company 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 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 our 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.


• 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 site 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.

What skills you will need:

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

• At least 10 years 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. 


• Meet the requirements of a Qualified Person as per EU Directive 2001/83/EC and 2001/20/EC 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.

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. 

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.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Number of Openings:

1

Requisition ID:R93315