Senior Specialist Quality Assurance

Job Description

At our company, we believe that every team member plays a vital role in ensuring the safety and quality of our products. We are looking for a passionate and dedicated Quality Assurance Specialist to join our diverse team, where your expertise will help us deliver exceptional service to our patients. If you are ready to make a meaningful impact in the biotech and pharmaceutical industry, we would love to welcome you aboard!

Welcome to Our Team

We are looking for a Quality Assurance Specialist to join our global Distribution and Logistics (D&L) Quality team. Our team supports to ensure that all products are handled and transported in accordance with all applicable company and regulatory requirements to meet both internal and external customer demands, the product license, Good Distribution Practices (GDPs) and contractual obligations. The Quality Assurance Specialist reports into the EMEA Regional Lead of D&L Quality and directly works with an experienced team of Quality professionals in both the internal and the external network to ensure the compliant and reliable supply of our products to our patients.

Purpose of the Position

• As a Quality Assurance Specialist, you will support our mission to ensure that all products are handled and transported in accordance with company and regulatory requirements. Your role is crucial in meeting both internal and external customer demands while adhering to Good Distribution Practices (GDPs) and contractual obligations.

• Main Responsibilities

• Quality Compliance Oversight: Support quality compliance oversight to ensure adherence to our global Quality Management System (QMS).

• Operational Quality Oversight: Provide quality oversight on Distribution & Logistics (D&L) operational activities, ensuring the quality performance of assigned suppliers, including Logistics Service Providers and Temperature Monitoring Devices suppliers.

• Collaboration for Improvement: Work closely with internal and external stakeholders to enhance the performance of transportation lanes by reviewing and addressing KPIs, CAPA effectiveness, and audit findings.

• Supplier Investigations: Lead investigations into supplier deviations related to transportation, logistics, and distribution.

• Change Control Management: Manage change control requests associated with D&L activities.

• Support Shipping Sites: Assist internal and external shipping sites in setting up and managing transportation lanes.

• GDP Requirements Support: Provide guidance to stakeholders regarding GDP requirements.

• Quality Agreement Negotiation: Collaborate with suppliers on due diligence and Quality Agreement negotiations.

• Audit Support: Support the Global Auditing Team in planning and scheduling external audits, and participate in the qualification and routine audits of suppliers/service providers.

• CAPA Review: Review and approve CAPA plans for audit observations, ensuring documentation is accurate and entered into the Audit Tracking System promptly.

• Thermal Protection Systems: Participate in the launch and approval of thermal protection systems, ensuring compliance with QMS requirements.

Your Profile

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, Engineering, or a related field.

• Relevant experience in the biotech/pharmaceutical or food industry.

• Expertise in Quality Systems, Quality Assurance, and Quality Control and good documentation practices.

• Experience with GDP/GMP is preferred

• Strong problem-solving skills grounded in science, data, and regulatory understanding, with the ability to apply sound risk management in complex environments.

• Excellent interpersonal, communication, and leadership skills, enabling effective collaboration across cultures in challenging situations.

• Fluency in English.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end bonus;

• 35,5 days of leave;

• Attractive collective health care insurance package with considerable reduction rates;

• Solid Pension Plan;

• Incentive Plan;

• Travel allowance for commuting;

• On-site sports facilities

• Numerous training, coaching and e-learning modules for long term job opportunities and development

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Audit Documentation, cGMP Regulations, Change Management, Compliance Oversight, Compliance Reviews, Deviation Management, Good Automated Manufacturing Practice (GAMP), Intellectual Property Licensing, Management Process, Manufacturing Compliance, Manufacturing Quality Control, Microbiology, Molecular Microbiology, Pharmaceutical Quality Assurance, Product Disposition, Quality Assurance (QA), Quality Auditing, Quality Control Management, Quality Management, Quality Management Standards, Quality Management System Auditing, Quality Standards, Regulatory Compliance {+ 5 more}

Preferred Skills:

Job Posting End Date:

06/27/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the 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: R351758