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**Job Function: **
Quality
**Job Sub Function: **
Quality Systems
Job Category:
People Leader
All Job Posting Locations:
Leiden, Netherlands
Job Description:
J&J Innovative Medicine is recruiting for a Contamination Control Program Lead reporting to the Site Quality Head Leiden Biotherapeutics and to be based in Leiden (Netherlands).
Job Summary
Key microbiological expert, partnering with site leadership to develop, maintain, and improve contamination prevention and hygiene programs. You will act as the primary subject matter expert, providing pragmatic guidance on contamination risk prevention under cGMP standards.
Key Responsibilities
- Lead contamination control program, risk assessments and strategies in line with cGMP, Johnson & Johnson, and regulatory standards.
- Drive initiatives to reduce contamination risks and enhance microbiological hygiene practices.
- Oversee environmental monitoring programs, trend analysis, and microbiological investigations for excursions.
- Design, implement, and deliver microbiology training and contamination control measures, including aseptic techniques, cleaning, disinfection, and sterilization.
- Collaborate on equipment and facility design, validation, and critical change approvals.
- Review quality control documents such as SOPs and work instructions.
- Innovate strategies for contamination reduction, including hand hygiene, gowning, and hygiene practices.
- Ensure microbiological quality standards are met for cleaning, sterilization, filtration, and depyrogenation.
- Advise on aseptic techniques and operator behaviors to minimize cross-contamination.
- Analyze microbiological and particulate trends, supporting corrective and preventative actions.
- Coordinate with microbiology and contamination control teams and ensure supplier compliance.
- Support regulatory compliance, safety policies, and best practices.
- Collaborate across teams to share best practices and support resource planning.
Requirements:
- Minimum of 10 years GMP experience in microbiology, preferably within the pharmaceutical or biotech industry
- Master’s degree or PhD in Microbiology or a related field
- Fluent in English (spoken and written)
- Proven leadership experience, including leading teams and projects, with demonstrated ability to operate effectively in a matrix organization
- Strong understanding of microbiological testing methods, validation, and regulatory compliance
Preferred Skills:
- Experience working in a highly regulated environment
- Excellent communication, organizational, and problem-solving skills
- Ability to work independently and as part of a multidisciplinary team
This role offers an exciting opportunity to impact microbiological quality and contamination control in a dynamic manufacturing environment.
"The anticipated base pay range for this position is 82,900 EUR to 144,210 EUR on an annual basis and includes 8% holiday allowance"
**Required Skills: **
Contamination Control, Quality Control Systems
Preferred Skills:
Data Quality, Developing Others, Leadership, Quality Control (QC), Quality Management Systems (QMS), System Integration, Team Management
The anticipated base pay range for this position is:
€82 900,00 - €144 210,00
Benefits:
In addition to base pay, we offer the following benefits*: 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. Moreover, we offer 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. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.