Quality Assurance Specialist

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.