Quality Leader: Qualified Person & CAPA Expert

Johnson & Johnson Innovation; Netherlands; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovation in Sassenheim, Netherlands, seeks a Quality Assurance professional to provide oversight of production, support quality investigations, and drive GMP compliance. You will coordinate CAPA and change controls, and serve as SME during regulatory inspections.

Minimum education includes a Bachelor’s degree in Biochemistry, Biology, or related field, with strong English skills and experience in GMP/regulatory environments.

Qualifications

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
• Proven knowledge of biotechnological/lentiviral/pharmaceutical industry.
• Proficiency in English both in word and in writing.

Responsibilities

• Provides Quality oversight to the production of Commercial and/or clinical AT Products (Lentiviral) at the site.
• Assess and review the outcome of Quality Investigations and monitor Root Cause investigations.
• Escalates serious quality, compliance and GMP incidents to Site or Global Management.
• Coordinates, reviews, and provides GMP training for site colleagues to ensure compliance to cGMP and company training requirements.
• Acts as Quality SME and participates in inspections (FDA, EMA etc.) to accomplish a successful audit.

Skills

Quality Oversight

GMP Compliance

QA Systems

Regulatory Knowledge

Risk Assessments

English Proficiency

Education

Bachelors in Biochemistry/Biology/Pharmaceutical Sciences

Job description

Johnson & Johnson Innovation in Sassenheim, Netherlands, seeks a Quality Assurance professional to provide oversight of production, support quality investigations, and drive GMP compliance. You will coordinate CAPA and change controls, and serve as SME during regulatory inspections.

Minimum education includes a Bachelor’s degree in Biochemistry, Biology, or related field, with strong English skills and experience in GMP/regulatory environments.