Operational QA consultant - 12 Months

Location: Leiden, Netherlands
Contract Duration: 12 Months
Industry: Biotechnology / Pharmaceutical Manufacturing
Function: Quality Assurance

Overview

An established biotechnology manufacturing site in Leiden is seeking an experienced Quality Assurance professional to join its Quality in the Plant team on a 12-month contract.

This position plays a critical role in supporting manufacturing operations through real-time quality oversight, ensuring compliance with GMP requirements, and driving quality excellence on the shop floor. The successful candidate will work closely with Operations, Manufacturing Science & Technology (MSAT), Engineering, Quality Control, Warehouse, and Training teams to ensure quality is embedded throughout manufacturing processes.

This is a highly visible role requiring strong decision-making skills, a collaborative mindset, and the ability to provide quality guidance within a fast-paced GMP-regulated environment.

Key Responsibilities

Shop Floor Quality Oversight

• Maintain a strong QA presence within manufacturing areas during assigned shifts.
• Provide real-time quality support during commercial and clinical manufacturing activities.
• Monitor critical process steps and GMP operations, including aseptic and cleanroom activities where applicable.
• Conduct routine GMP observations, floor walks, and GEMBA activities.
• Ensure compliance with procedures, data integrity requirements, contamination control strategies, and cleanroom behaviours.
• Support process confirmation and manufacturing oversight activities.

Operational Quality Support

• Serve as the primary QA contact for manufacturing-related quality events and operational queries.
• Support the initiation, assessment, containment, and escalation of non-conformances and deviations.
• Participate in investigations, fact-finding activities, and operator interviews.
• Assess quality impact and support risk-based decision making.
• Partner with manufacturing teams while maintaining independent quality oversight.

Quality Systems & Compliance

• Review and approve deviations, investigations, CAPAs, change controls, and GMP documentation within the assigned scope.
• Participate in root cause investigations and quality risk assessments.
• Support site inspection readiness activities.
• Ensure ongoing compliance with applicable GMP regulations and internal quality standards.
• Contribute to continuous improvement initiatives across quality systems and manufacturing processes.

Operational Integration

• Participate in daily operational meetings and shift handovers.
• Review significant manufacturing events and quality issues.
• Support electronic manufacturing systems, exception management processes, material status activities, and related quality workflows.
• Collaborate effectively with cross-functional teams to support compliant manufacturing operations.

Quality Culture & Coaching

• Promote GMP excellence and quality ownership throughout manufacturing operations.
• Coach operators and operational teams on quality expectations and compliance requirements.
• Support continuous improvement and inspection readiness initiatives.
• Act as a trusted quality partner and role model across site operations.

Candidate Requirements

Education

• Bachelor's degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.

Experience

• Minimum 6 years' experience within a GMP-regulated environment with a Bachelor's degree, or 4 years' experience with a Master's degree.
• Previous experience in Quality Assurance, Manufacturing Operations, Quality Control, Compliance, or a related pharmaceutical function.
• Demonstrated experience managing deviations, investigations, CAPAs, and quality risk assessments.
• Experience making compliance-based decisions within manufacturing environments.
• Experience supporting aseptic processing, sterile manufacturing, biologics production, or contamination-controlled operations is highly desirable.

Knowledge & Skills

• Strong working knowledge of GMP requirements and pharmaceutical manufacturing processes.
• Experience with deviation management, change control, CAPA, and quality risk management systems.
• Understanding of manufacturing operations and shop floor processes.
• Strong communication, stakeholder management, coaching, and influencing skills.
• Ability to make sound, risk-based quality decisions in a dynamic operational environment.
• Experience using electronic quality systems, MES, SAP, or related manufacturing platforms is advantageous.
• Strong analytical and problem-solving capabilities.

Working Pattern

The role will initially operate on a daytime schedule to support onboarding and qualification activities.

Following onboarding, the position will transition into a shift-based Quality in the Plant model supporting extended manufacturing operations:

• Early Shift: 07:00 - 15:30
• Late Shift: 15:00 - 23:30