Senior Specialist, External Quality

Job Description

Our Quality Assurance group ensures that products are manufactured, processed, tested, packaged, stored and distributed aligned with our 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 External Quality Senior Specialist is responsible for ensuring that all our products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements.   

Primary activities include, but are not limited to: 

• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign. 

• Evaluate and/or release products with the assurance that the goods were manufactured in conformance to all applicable policies/procedures of the Company and compliance with all governing regulations; review and approve master batch records and changes to batch records and laboratory methods/specifications. 

• Perform annual product reviews 

• Review executed batch records 

• Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements. 

• Accountable for oversight of EEs 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. 

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

As this role is a remote role in Ireland travel is required - 25%, occasionally on short notice. You must be based in Ireland and will be connected to the Leopardstown office.

REQUIRED: Education and Experience: 

• Education: degree in Science, Engineering or other relevant technical discipline  

• Minimum of 5 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. 

• Experience in batch disposition, deviation management and/or change controls 

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

• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership 

Preferred Experience and Skills: 

• Experience with biologic products and sterile drug products 

• Eligible to be named as a Qualified Person (QP) 

• Experience with managing external partners (CMOs, Labs, etc.) 

• Previous experience participating in regulatory inspections. 

• Be conversant with all domestic and foreign regulations and compendia governing plant operations. 

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.  

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.  

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.  

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model 

So, if you are ready to: 

Invent solutions to meet unmet healthcare needs, please apply today. 

Current Employees apply HERE

Current Contingent Workers apply HERE

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Search Firm Representatives Please Read Carefully 
Merck & 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R278295