Principal GMP Quality Engineer

Labcorp is expanding its global BioPharmaceutical Chemistry Manufacturing and Control (CMC) footprint and is opening a new CMC facility in Mechelen Belgium.

Biopharmaceutical CMC provides independent objective GMP analytical testing for manufactured medicinal products from late discovery through post-market approval on behalf of global clients. With a strong portfolio of clients and over 25 years of expertise the BioCMC team provides advanced characterization method development stability and routine QC release for biologics vaccines ATMPs and a breadth of other complex biomolecules.

With this new laboratory in Belgium we aim to offer a more comprehensive solution and accelerate the availability of new products for patients. The new site has been strategically developed to complement our existing capabilities in York and Harrogate (UK) and Greenfield (US) and introduce a new CMC analytical testing solution for commercial drug products in the European Union (EU).

This expansion is a key milestone in our long-term plan to strengthen support for pharmaceutical and biotechnology partners who rely on Labcorp for complex CMC and regulatory testing services. If you would like to join us and be a part of this exciting journey take a look at the fantastic opportunities we have to offer.

Location: Onsite

Were looking for a handson Principal Quality Engineer GMP to establish and drive the quality operation for our new Mechelen facility.

In this role you will oversee the GMP quality management system approve key quality records host client audits and act as the primary QA contact for the site.

You will lead a small team collaborate closely with global QA colleagues and play an active role in company-wide quality reviews.

Daytoday youll manage audits handle escalations review documentation and engage directly with clients.

In the first months youll help bring the facility online supporting equipment and facility validation building QA documentation and preparing for regulatory inspection and certification.

This is a unique opportunity to shape a new site solve problems and lead local operations within a global quality framework.

Job Responsibilities:

• Plays a leading role in the implementation of a quality management system that complies with domestic and international regulations. Ensures local compliance with the QMS requirements.
• Leads/influences the organization by providing niche subject matter expertise managing QA-to-QA relationships with clients and/or overseeing global initiatives aimed at improving compliance and/or QA efficiency
• Supervisory responsibility for a segment of the QA team providing workload assignment recruitment performance evaluation professional and personal training and development implementation and follow-up of site departmental objectives etc.
• Oversees and approves Quality Related Issue Resolutions Corrective / Preventive Actions (CAPA) Change Controls Vendor Management Complaint Handling Continual Improvement and NCM/MRB systems as appropriate. Engineers solutions to address product and process quality issues.
• Promote quality improvement and compliance with the applicable regulations and associated quality management system by leading the development / delivery of regulatory based training application of quality risk management and effective reporting and responding to quality metrics and data trends supporting the Management Review Process; leads the assessment and reporting of post-market surveillance data in accordance with regulatory requirements.
• Supports the annual audit program by scheduling planning leading reporting and following up of internal audits leading / supporting external vendor assessments and hosting regulatory and client inspections
• Study Specific Oversight
  • Pharmaceutical GMP Studies: Provides regulatory approval and accountability for release (or rejection) of study related documentation (i.e. batch records methods protocols reports certificates of analysis etc.) and/or pharmaceutical material/product for use in clinical trials. Note that release of IMP in UK requires batch certification by a Qualified Person (QP).
  • CDx Studies: Support the research development and manufacturing of CDX in-vitro diagnostic (IVD) medical device products. Lead the planning design preparation execution reporting and analysis of design verification and validation efforts to qualify materials tools equipment systems processes and software used in the testing processing manufacturing storing and distribution of IVD products.
• Represents QA on key projects to ensures facilities utilities equipment and computer systems are appropriately validated/qualified; approval of key validation deliverables
• Reviews and approves controlled documents (SOPs Policies etc.) to ensure compliance with applicable regulations Labcorp document management procedures and other relevant quality standards
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities as indicated in applicable controlled documents are followed.
• Other duties as assigned by management.

Minimum Qualifications:

• Minimum: Bachelor Degree e.g. Biology Biochemistry Chemistry Pharmacy or relevant Engineering discipline
• Minimum 7 years of experience in GMP Quality Assurance role in manufacturing or testing environment
• Minimum a first leadership experience
• Experience with review and approval of CAPA change control deviations
• Fluency in English and Dutch

Preferred Qualifications:

• Relevant post graduate degree (MSc PhD etc.) preferable
• Higher level qualification and/or equipment management /regulatory qualifications
• Experience of equipment validation/qualification
• Preferably holds a relevant quality accreditation such as Lead Auditor Certification Quality Engineer Certification Sigma Black Belt
• Experience with lab set-up and initiation in a GMP regulated environment

Additional Job Standards:

• In depth understanding of applicable regulations and quality management systems / principles tools and standards.
• Excellent leadership and interpersonal / organizational skills e.g. communication decision making problem solving data analysis negotiating influencing
• Client facing and audit experience
• Qualified Person (QP) Eligibility as required (GMP QA only)
• Open for occasional travel to other sites when appropriate

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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