QA Associate CSQ Laboratories

We are searching for the best talent for the position of QA Associate CSQ for the Laboratory team responsible for quality oversight and support of the cell and gene laboratories located at Leiden and their contract laboratories.

Purpose:

We are looking for a quality-oriented person with an analytical and scientific mindset to join our dynamic multidisciplinary team as a QA Associate CSQ that will be responsible for the site and operational compliance of the clinical laboratories. The QA Associate CSQ will review and approve procedures and documents that are supporting the analytical and microbiological activities, support external audits from heath authorities and customers, support/execute internal audits, and check rounds to monitor the compliance of the laboratory areas and the performance of the processes and activities, review and approve quality investigations and change controls, provide or support quality metrics in support of quality reporting. The QA Associate CSQ will closely interact with the CSQ lab team, business partners and other departments to ensure quality is incorporated in processes and support the informed decision-making process. Together with this exciting function in a dynamic and international environment, we ensure diversity in your work and support personal development.

You will be responsible for:

• Quality point of contact for cell and gene laboratories at Leiden and their contract laboratories.
• Acts as Quality Subject Matter Expert (SME) for assigned quality processes and/or analytical techniques ensuring an appropriate quality and compliance level by applying risk management in line with the intended use and phase of development.
• Establish and develop cooperative working relationships within and across the cell and gene laboratories, CSQ, global quality organization, including single quality voice in the analytical area.
• Review and approval of laboratory related documents such as validation/transfer/ investigation protocols and reports, procedures and work instructions.
• Handle quality issues, CAPAs, and change controls that are initiated by our business partners and/or their contractors and contract laboratories.
• Ensure that Quality and Compliance operational targets are met.
• Support quality oversight via periodic quality reviews e.g. internal audits, quality metrics, round tours.
• Work with the supported business partners and their contractors/contract organizations to improve the quality culture and positively influence Quality KPI.
• Report Quality trends and makes a positive contribution via ideas for improvement
• Involvement in implementation of new insights, process improvements and departmental strategic discussions.
• Support and act as spokesperson during Health Authority inspections and customer audits.
• Travel for short periods for training or business purposes.
• Comply to EHS and GMP-standards and acts according to J&J Credo principles.

Qualifications / Requirements:

• Master’s degree or equivalent by experience in science e.g. (bio-)pharmaceutical, chemical or biological sciences
• 3-5 years’ experience in pharmaceutical industry, preferably in Quality Assurance / Quality Control
• Operational experience and affinity with laboratory environment e.g. method development, method validation, release & stability testing, microbiology
• Operational experience in a quality role
• Technical experience in instrument qualification, automation is an asset.
• Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering in a global environment.
• Positively react to changes and show agile behavior e.g. dealing with different quality levels to support fit for purpose quality in an R&D environment.
• Knowledge of cGMP and ICH guidelines
• Experience with regulatory inspections as spokesperson, backroom role, preparation is an asset.
• Capable of working under pressure.
• Precise and eye for detail.
• Excellent verbal and written communication skills (Dutch & English)
• Demonstrates Divers & Inclusive behavior.
• Team player
• Excellent organization and interpersonal skills; ability to work with various partners and influence decision processes.
• Proactive in the identification of issues, demonstrates problem-solving capabilities, and timely implements solutions.
• Is willing to think and challenge beyond own expertise area.

Preferred Skills:

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

Hybrid Work