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JOB DESCRIPTION:

Within Advanced Therapies, we have an opportunity for an experienced Senior Supervisor to lead the Quality Assurance team located in our manufacturing facility in Sassenheim, the Netherlands. QA-AT supports the clinical and commercial manufacturing of Lentivirus, an important component for Johnson and Johnson’s CAR-T therapy.
The Senior Supervisor will focus on building and shaping a QA team that supports the daily operations and provides quality oversight over manufacturing. QA-AT plays a crucial role in ensuring that our processes meet the highest standards of quality and GMP compliance by supporting various base business activities needing quality assurance expertise. That includes among others, batch record review/approval, (raw) material and LV release, various documentation and changes review/approval , non conformances and deviations assessments/approval. Additionally, the Senior Supervisor will play a vital role in establishing and onboarding new processes aligned with aseptic manufacturing standards, for example AQL inspection (visual inspection of vials), QAPOP (Quality Aseptic Processing Oversight) etc.
The Senior Supervisor works in close collaboration with other local or global departments (Operations, Warehouse, QC, GET, MSAT and other site Quality teams).

EXPERIENCE AND SKILLS

• Previous experience as people leader, strong team management skills.
• Proven experience in quality assurance, preferably in aseptic or sterile manufacturing.
• Ability to support change management and process implementation activities.
• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.
• Problem solving, analytical thinking and decision making capabilities.
• Highly organized, capable of managing multiple tasks in a team environment, and able to work effectively under minimal supervision while maintaining a positive attitude.

• Lead and oversee the QA team. Assign and prioritize activities within the team to meet operational goals and deadlines.
• Responsible for the efficient and effective functioning of the team including coordination and direct supervision of activities, ensuring on time completion according to commitments.
• Collaborate with cross-functional teams to set up and implement new processes.
• Evaluates performance and provides opportunities for growth, conduct performance appraisals and ensure alignment of G&O of direct reports to the company objectives.
• Develop, coach and mentor direct reports.
• Recruitment and hiring of new people, ensuring proper onboarding and training.
• Ensures that GMP/GLP guidelines, compliance best practices, EHSS regulations are followed by team members.
• Monitor team performance metrics and drive continuous improvement initiatives to enhance quality and compliance.
• Act as primary contact for other teams/departments ensuring clear communication and alignment.