Experienced Specialist QA

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

You will support quality investigations, quality risk management activities, inspection readiness, and compliance initiatives while working closely with cross‑functional partners across the site.

The role includes participation in investigations, risk management activities, inspection readiness initiatives, and change management processes, while helping ensure compliance with company standards and regulatory requirements.

Key responsibilities include providing timely and practical quality guidance on cGMP and quality‑related topics, leading and supporting site investigations, supporting preparation activities for regulatory inspections (including FDA and EMA), reviewing deviation‑related change controls, and assessing study protocols and reports.

Key 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

Strong communication, collaboration, and advisory skills in Dutch and English, both written and verbal

• Up‑to‑date knowledge of GMP regulations and quality systems
• 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
• Familiarity with Process Excellence, Lean tools, concepts, and methodologies is preferred
• Strong analytical and problem‑solving skills
• Ability to work effectively across teams and manage multiple priorities in a dynamic environment
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

• An annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions
• Vacation days
• Parental leave for a minimum of 12 weeks
• Bereavement leave, caregiver leave, volunteer leave
• Well‑being reimbursement
• Programs for financial, physical and mental health
• Service anniversary and recognition awards
• Employees - and in some location’s eligible dependents - can participate in several insurance plans
• The annual base pay includes an 8% holiday allowance

Education Requirements

• Bachelor's degree in Bioscience, Chemistry, Pharmacy, or a related scientific discipline with 4–6 years of relevant experience, or
• Master's degree in Bioscience, Chemistry, Pharmacy, or a related scientific discipline with 2–4 years of relevant experience