Senior QA Specialist - cGMP, Investigations & Inspections

Leiden Bio Science Park; Leiden; On-site; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Health programs

Service awards

Insurance plans

Holiday allowance

Job summary

Leiden Bio Science Park is seeking a quality professional to support investigations, risk management, inspection readiness, and compliance initiatives across the site. You will provide timely guidance on cGMP topics and lead investigations, CAPAs, and QA activities with cross-functional partners.

The role includes reviewing deviation-related change controls and ensuring studies and reports are conducted in a controlled, compliant manner, including validation and stability studies, while aiding

Qualifications

• Bachelor's degree in Bioscience, Chemistry, Pharmacy, or a related scientific discipline with 4–6 years of relevant experience.
• Master's degree in Bioscience, Chemistry, Pharmacy, or a related scientific discipline with 2–4 years of relevant experience.
• Experience in Quality Assurance within the pharmaceutical industry or a related regulated environment is preferred.
• Experience with quality investigations, root cause analysis, and quality risk management.
• Strong analytical and problem-solving skills.
• Knowledge of GMP regulations and quality systems.

Responsibilities

• Providing timely and practical quality guidance on cGMP and quality-related topics
• Leading and supporting site investigations and helping ensure corrective and preventive actions (CAPAs) are implemented effectively within agreed timelines
• Supporting preparation activities for regulatory inspections, including FDA and EMA inspections
• Reviewing, assessing, and approving deviation-related change controls
• Partnering with site colleagues to help ensure projects and changes are executed in compliance with cGMP requirements and company standards
• Assessing, reviewing, and approving study protocols and reports to help ensure activities are conducted in a controlled and compliant manner, including validation and stability studies
• Participating in Quality Risk Management activities and root cause investigation sessions
• Contributing to quality and compliance initiatives that support continuous improvement across the organization

Skills

GMP knowledge

Quality Assurance

Root cause analysis

Analytical skills

Dutch language

English language

Cross-functional collaboration

AI concepts awareness

Education

Bachelors in Bioscience/Chemistry/Pharmacy

Masters in Bioscience/Chemistry/Pharmacy

Tools

Lean tools

Quality systems

Job description

Leiden Bio Science Park is seeking a quality professional to support investigations, risk management, inspection readiness, and compliance initiatives across the site. You will provide timely guidance on cGMP topics and lead investigations, CAPAs, and QA activities with cross-functional partners.

The role includes reviewing deviation-related change controls and ensuring studies and reports are conducted in a controlled, compliant manner, including validation and stability studies, while aiding