Quality Assurance Specialist

EPM Scientific; Beerse; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

EPM Scientific is seeking an experienced Quality Assurance professional to lead global serialization quality and support a Manufacturing Digital Connect integration in Beerse. The role oversees QA governance across cross-functional teams, ensuring alignment with evolving regulatory requirements and quality standards.

The position focuses on developing a unified global serialization quality framework and coordinating with Regulatory, IT, and Manufacturing to embed quality-by-design principles

Qualifications

• Minimum 8 years' experience in Quality within pharmaceutical, biotechnology, or regulated manufacturing environments.
• At least 3 years' experience supporting global serialization, track-and-trace, or supply chain compliance programmes.
• Proven experience authoring, implementing, and maintaining global GxP procedures, work instructions, and quality management documentation.
• Strong understanding of international serialization regulations, including US DSCSA and China NMPA traceability requirements.
• Technical knowledge of serialization systems, exposure to manufacturing automation and data integrity principles is desirable.
• Demonstrated expertise in risk management, change control, and quality compliance within regulated environments.
• Strong stakeholder management skills with the ability to influence and collaborate across Global Quality, Regulatory Affairs, IT/Digital, Manufacturing Operations, and commercial stakeholders.
• Excellent written and verbal communication skills, particularly in developing global procedures and delivering training.

Responsabilités

• Serve as Global Quality SME for serialization-related quality and compliance activities.
• Lead the development, harmonisation, and deployment of a single global serialization SOP framework replacing local site docs.
• Interpret global regulatory requirements into practical quality processes and site procedures.
• Drive alignment across manufacturing sites for consistent serialization standards and quality expectations.
• Lead quality training and competency development for new global procedures.
• Provide guidance on change controls, risk assessments, deviations, and compliance for serialization processes.
• Act as Quality lead for Manufacturing Digital Connect integration program and assess quality impact of new digital capabilities.
• Define global quality requirements and documentation standards as programs evolve.
• Collaborate with Quality, IT, Digital, Operations, and Regulatory teams to embed quality-by-design throughout implementation.

Connaissances

Quality management

GxP

Risk management

Change control

Documentation

Training & development

Stakeholder management

Communication

Formation

Bachelor's degree in Pharmacy, Life Sciences, Engineering or related discipline

Advanced degree or quality certifications

Description du poste

We are seeking an experienced Quality Assurance professional to join two strategic global initiatives within a pharmaceutical manufacturing environment. Acting as the Quality representative, you will provide leadership, governance, and compliance oversight across global cross-functional teams, ensuring alignment with evolving regulatory requirements and quality standards.

The position is primarily focused on developing and implementing a unified global serialization quality framework, while also supporting the introduction of a new Manufacturing Digital Connect integration platform and its associated quality requirements.

Contract Length: 12 months freelance contract

Start Date: ASAP

Location: Beerse - 3 days on site and 2 days wfh

Key Responsibilities

Global Serialization Program (Primary Focus)

• Serve as the Global Quality representative and subject matter expert (SME) for serialization-related quality and compliance activities.
• Lead the development, harmonisation, and deployment of a single global serialization SOP framework, including procedures and work instructions, replacing local site-specific documentation.
• Interpret and translate global regulatory requirements into practical quality processes, controls, and site-level procedures.
• Drive alignment across manufacturing sites to ensure consistent implementation of serialization standards and quality expectations.
• Lead quality training and competency development activities, ensuring effective adoption of new global procedures.
• Provide guidance on change controls, risk assessments, deviations, and compliance considerations related to serialization processes.

Manufacturing Digital Connect Program (Secondary Focus)

• Act as the Quality lead for the implementation of a new manufacturing integration layer, Manufacturing Digital Connect.
• Assess the quality and compliance impact of new digital manufacturing capabilities.
• Define global quality requirements and documentation standards as the program evolves.
• Collaborate with Quality, IT, Digital, Operations, and Regulatory teams to ensure quality-by-design principles are embedded throughout implementation.

Required Experience & Qualifications

• Minimum 8 years' experience in Quality within pharmaceutical, biotechnology, or regulated manufacturing environments.
• At least 3 years' experience supporting global serialization, track-and-trace, or supply chain compliance programmes.
• Proven experience authoring, implementing, and maintaining global GxP procedures, work instructions, and quality management documentation.
• Strong understanding of international serialization regulations, including:
• US Drug Supply Chain Security Act (DSCSA)
• China NMPA traceability requirements or similar national repository models
• Technical knowledge of serialization systems, with exposure to manufacturing automation and data integrity principles considered highly desirable.
• Demonstrated expertise in risk management, change control, and quality compliance within regulated environments.
• Strong stakeholder management skills with the ability to influence and collaborate across Global Quality, Regulatory Affairs, IT/Digital, Manufacturing Operations, and commercial stakeholders.
• Excellent written and verbal communication skills, particularly in developing global procedures and delivering training.

Education

• Bachelor's degree in Pharmacy, Life Sciences, Engineering, or a related discipline.
• Advanced degree or relevant quality certifications would be advantageous.