External Site Quality Leader - AD, global role

Merck Gruppe - MSD Sharp & Dohme; Rahway (NJ); Remote; USD 100,000 - 150,000; Full time

Job summary

A leading biopharmaceutical organization is seeking an External Site Quality Leader to ensure compliance and quality standards in its operations. The role involves oversight of manufacturing processes, regulatory adherence, and maintaining quality in product testing. Ideal candidates will possess significant industry experience and a strong educational background in science or engineering.

Benefits

Flexible working arrangements

Opportunity for continuous improvement initiatives

Qualifications

• 8 years of experience in the pharmaceutical/biotechnology industry.
• Knowledge of global GMP and regulatory requirements.
• Experience in manufacturing operations and analytical expertise in biologics.

Responsibilities

• Provide quality oversight for external manufacturing/testing entities.
• Ensure compliance with company policies and regulations.
• Manage quality control functions and handle regulatory inspections.

Skills

Problem Solving

Interpersonal Skills

Communication

Quality Assurance

Adaptability

Education

Bachelor's or Master's Degree in Science or Engineering

Job description

Job Description

Join our company, a premier research-intensive biopharmaceutical organization, where we are at the forefront of delivering innovative health solutions. As an External Site Quality Leader (ESQL), you will play a critical role in ensuring the highest standards of quality and compliance in our manufacturing and testing operations. This is an exciting opportunity to be part of a global network dedicated to delivering reliable and compliant products to our customers and patients.

Your Core Responsibilities

• Provide Quality Oversight for External Entities manufacturing or testing cell banks, biologic drug intermediates, substances, or products.
• Ensure products comply with our company's policies, procedures, and regulations before further processing.
• Oversee Quality Control functions, including product testing, batch documentation review, and deviation investigations.
• Manage the complete processes of transfers, including Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness, and Quality System Oversight Implementation.
• Ensure audit readiness, support regulatory inspections, and manage complaints effectively.
• Oversee change control, conduct metric reviews, and perform annual product reviews.
• Build effective quality systems at External Entities and drive continuous improvement initiatives.
• Exhibit our company's Leadership Behaviors and set a leadership example for the team.
• Maintain compliance with established policies/procedures and all applicable governmental regulations, both domestic and foreign.

Who You Are

You are ready if you have:

• Bachelor's or master’s degree in Science, Engineering, or a related field.
• Eight years of relevant experience in the pharmaceutical/biotechnology industry with knowledge of Quality Systems, Quality Assurance, and Quality Control, including global GMP and regulatory requirements.
• Experience with manufacturing operations and/or analytical expertise in biologics and/or vaccines, including aseptic manufacturing.
• Competent in analyzing complex product, production, and testing issues with demonstrated scientific problem-solving capabilities.
• Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills.
• Ability to work independently with minimal guidance and proficient in verbal and written communication in English.

Nice to have, but not essential:

• Direct experience managing external partners (CMOs, Labs, etc.).
• Experience in batch disposition, deviation management, change control, and participating in regulatory inspections.
• Knowledge of compliance regulations and standards in regions outside of Europe, such as North America, Asia-Pacific, Latin America, or other relevant markets.

As this role is a remote role in Ireland, Switzerland or Spain travel is required (outside of the EU) - 20%, occasionally on short notice.You must be based in one of these countries for your application to be considered.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

As a company, we are committed to 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.

So, if you are ready to:

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

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Applied Engineering, Complaint Management, Decision Making, Deviation Investigations, Deviation Management, GMP Compliance, Interpersonal Relationships, Management Process, Negotiation, Partner Relationship Management (PRM), Persuasion, Process Improvements, Quality Agreements, Quality Assurance (QA), Quality Assurance Processes, Quality Control (QC), Quality Control Management, Quality Management, Quality Management Systems (QMS), Regulatory Compliance, Regulatory Compliance Audits, Regulatory Inspections, Risk Management {+ 4 more}

Preferred Skills:

Job Posting End Date:

06/13/2025

*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.

Requisition ID:R353077