Job Information
J&J Family of Companies Senior QA Associate in South Holland, Netherlands
Senior QA Associate - 2406183529W
Description
We are seeking a highly skilled and motivated Risk Management and Regulatory Compliance Specialist to join our team.
In this role, you will be responsible for leading various aspects of risk management, regulatory compliance, and governance activities within our QA Organization supporting Advanced Therapies Clinical Productions. Your expertise in risk management, regulatory requirements, and compliance to global standards will contribute to ensuring a safe and compliant working environment.
Responsibilities:
Risk Management Expertise: Assess and implement risk management strategies, methodologies, and processes to identify, evaluate, and mitigate risks across the organization.
Adopting Regulatory Requirements Lead: Stay informed about regulatory requirements in the industry and ensure their adoption within our organization. Proactively analyze and interpret new regulations, conducting assessments to identify their impact and developing appropriate implementation plans.
New Regulation Screening and Assessment SPOC: Act as the single point of contact for the screening and assessment of new regulations. Collaborate with relevant stakeholders to evaluate the impact of new regulations on existing processes and develop action plans for compliance.
Compliance to Global Standards and Global SOPs SME: Serve as a subject matter expert on compliance with global standards and global standard operating procedures (SOPs). Provide guidance and support to ensure adherence to established standards and SOPs, facilitating continuous improvement to meet regulatory requirements.
Metrics Reporting: Collect and analyze data related to risk management and compliance metrics. Prepare reports and presentations to document and communicate the performance of risk management processes and compliance activities to relevant stakeholders.
Governance Meetings Coordinator: Plan and coordinate governance meetings, including agendas, presentations, and minutes. Ensure timely follow-up on action items and monitor the progress of assigned tasks.
Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
Qualifications
A minimum of a Master Degree in Engineering, Pharmacy, Science or equivalent technical area is required
5 years of relevant experience
Experience with Quality Assurance and Quality Systems is required
Strong knowledge of regulatory requirements and standards, including the ability to interpret and apply them effectively.
Previous experience interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc, and a history of success and credibility resolving complex regulatory compliance issues
Extensive experience in risk management, regulatory compliance, and governance within a similar industry.
Knowledge of the business environment inside a Quality organization across various roles is required
Experience in Biologics and/or Cell therapy is preferred
Experience in Change management and project management.
Ability to analyze issues and determine how to apply policies and processes to meet goals
Ability to resolve and manage operational and quality problems
Excellent organizational skills with the ability to manage multiple tasks and priorities.
Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.
Attention to detail and a strong focus on accuracy in documentation and reporting.
Proficiency in using relevant software and tools for risk management, compliance, and reporting.
Fluent verbal and written English communication skills; other language skills advantageous
Join our team and contribute to maintaining a strong risk management framework and regulatory compliance to ensure the highest quality standards in our operations.
Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization Janssen Vaccines & Prevention BV (8852)
Job Function Quality Assurance
Req ID: 2406183529W