QC Project Leader (m/f/d) fixed term sick leave coverage

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

QC Project Leader (m/f/d) fixed term sick leave coverage

Job-ID: R-01350791

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Location/Division Specific Information

• Multi-product, multi-client biopharmaceutical site with development and manufacturing facilities supporting Phase I, II, and III clinical trials, as well as commercial applications.

• Environment operating under strict Good Manufacturing Practice (GMP) requirements and regulations enforced by national and international health authorities.

• High-value intermediate and finished products requiring an exceptionally rigorous level of control.

• Extensive interaction with internal teams (Production, Analytical Development, Quality Assurance (QA), and Project Management) as well as external partners (clients).

Discover Impactful Work:

The QC Project Leader is responsible for the end-to-end coordination and execution of Quality Control (QC) activities for assigned projects within a GMP-regulated biopharmaceutical environment. The role covers the entire product lifecycle, from development and engineering batches through clinical and commercial applications.

In this capacity, the QC Project Leader defines analytical strategies, ensures the timely delivery of QC deliverables, and oversees the generation of documentation and results that comply with both client and regulatory requirements.

A day in the Life:

Analytical Strategy and Project Setup

• Define the QC analytical testing panel (in-house and outsourced methods) in collaboration with the client and Analytical Development (DevA).

• Ensure the implementation of analytical Master Batch Records/Testing Specifications (GFE) for raw materials and products, in coordination with Production, Supply Chain, and contractual milestones.

• Ensure method transfer activities are planned and executed before the first engineering batch.

• Inform QC laboratories of incoming R&D samples (bioburden, endotoxins, etc.).

Planning and Coordination of QC Activities

• Develop and maintain sampling plans for engineering and clinical batches in accordance with regulatory and contractual requirements.

• Define and maintain stability plans, with client approval.

• Coordinate sample flows between Production and QC.

• Interface with QC Managers and Manufacturing to ensure deadlines are met.

LIMS and Systems Management

• Configure and maintain QC projects within the LIMS, including creation of specifications (MLPs), certificate templates, and workflows for engineering and clinical batches.

• Create product samples in the LIMS for assigned projects.

• Ensure data accuracy and integrity across all systems (LIMS, SAP, Documentum).

• Perform associated SAP activities.

Engineering and Clinical Batches

• Define specifications and sampling plans with key stakeholders (client, DevA, QC) for engineering and clinical batches.

• Establish, adapt, and manage stability protocols for Drug Substance (DS) and Drug Product (DP).

• Replicate and adapt engineering-phase processes for clinical batches, including LIMS configuration.

• Oversee data entry, execution, and reporting of QC tests and results within established timelines.

• Coordinate preparation of Certificates of Analysis (CoAs), manage approval workflows, and ensure compliance and QA approval.

Documentation and Reporting

• Draft and review Certificates of Analysis (CoAs), stability reports, and shelf-life reports.

• Ensure traceability, version control, and compliance of all QC documentation.

• Notify the Qualified Person (QP) when a Certificate of Analysis is issued to enable batch release.

• Ensure the release of raw materials tested by QC technicians (including conditional releases where applicable) once all analyses have been completed.

• Support client audits by providing QC documentation and technical explanations.

Commercial Batch and Lifecycle Activities

• Monitor the QC status of raw materials.

• Track ongoing stability studies.

• Contribute to Continued Process Verification (CPV) activities for PPQ and commercial batches through integration of QC raw data.

• Support the preparation and review of Annual Product Reviews (APRs).

• Assess and implement change orders impacting QC activities.

Client and Stakeholder Management

• Serve as the primary QC point of contact for assigned projects.

• Communicate schedules, results, and technical information to clients.

• Respond to client requests related to analytical testing, including access to raw data.

• Ensure alignment between QC, Project Management, Analytical Development, Production, and external partners.

• Participate in client audits for documentation under their responsibility.

Quality, Compliance, and Safety

• Ensure full compliance with GMP requirements and internal quality standards.

• Maintain data integrity and inspection readiness.

• Apply individual and collective safety rules, including the use of Personal Protective Equipment (PPE).

• Maintain work areas in a clean and organized condition.

• Participate in continuous improvement initiatives.

• Perform additional duties within their area of expertise as requested by management.

Keys to Success:

Education

• Master's degree (Bac+5) in Biology, Biochemistry, Chemistry, or a related field.

Experience

• Minimum of 5 years of proven experience in Pharmaceutical or Biopharmaceutical Quality Control (QC).

• Experience working in a Quality Control laboratory within a GMP-regulated environment.

Technical Skills

• Strong understanding of QC operations, GMP requirements, and regulatory expectations.

• Proficiency in LIMS, SAP, and data management systems.

• Project planning and coordination skills, including the use of Gantt charts, scheduling tools, and dependency management.

• Strong analytical and problem-solving abilities.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Language:

• French: Fluent/Professional proficiency (mandatory)

• English: Fluent/Professional proficiency (mandatory)

• Dutch: Considered an asset

What we offer:

• Employment with an innovative, future-oriented organisation

• Outstanding career and development prospects

• Company pension scheme and other fringe benefits

• Exciting company culture which stands for integrity, intensity, involvement and innovation

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.

Apply today!

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