Senior QA Associate / Senior QA Officer
Department: QA CMO/PDQ
The Quality Assurance department at Janssen Vaccines & Prevention in Leiden is a fast-developing department. Janssen Vaccines & Prevention is currently working on a full Vaccine pipeline, developed at our site in Leiden and by external collaborations. The QA team is responsible for overseeing and supporting the quality systems, projects and facilities. The opportunities and responsibility for the Quality Assurance department to shape and deliver the right quality are key for the success of Janssen Vaccines & Prevention. The team is most successful with employees that are pro-active and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.
The Senior QA Associate assures compliance with regulatory requirements and internal Johnson and Johnson procedures via appropriate oversight and planning, conducting, and reporting quality inspections, report audits, internal and external facility evaluations, system audits, and data reviews that support company late stage development projects. Furthermore, the Senior QA Associate supports release activities.
Key responsibilities for the function as a Senior QA Associate / Senior QA Officer:
- Supplier management including auditing, monitoring and maintenance of Quality agreements suppliers including external manufacturing, laboratories, GMP services and GMP raw material suppliers;
- QA oversight of validation, qualification activities connected to drug substance and drug product manufacturing;
- Assesses compliance with regulations for late stage development matters;
- Participates in regulatory agency inspections, (global) project team meetings, and training activities;
- Communicates effectively with professional staff and leadership across departments;
- Effective stakeholder manager, able to influence. The ‘go-to’ person on difficult content issues;
- Challenges the status-quo. Involved in conception of new ideas with respect to improvement of business processes or procedures;
- Leads the execution of systems aimed at evaluating and maintaining quality and compliance;
- Complies to EHS and GMP-standards and has solid JnJ Credo awareness acting accordingly;
- Drafts, revises, reviews and contributes quality assurance guidelines to research and development standard operating procedures;
- Leads process improvements and contributes to the ongoing development of new procedures, techniques and departmental guidelines;
- Is able to independently prepare batch (DS and DP) dossiers to facilitate technical release.
Key requirements for the function of a Senior QA Associate / Senior QA Officer:
- Independent and organized accurate worker, with eye for detail and good writing skills;
- Is able to think and challenge beyond own expertise area, conceptual (end to end) thinker;
- Is pro-active in the identification of issues, has problem-solving capabilities, and timely implements solutions;
- Technically skilled (DS and DP manufacturing, Quality Systems, Process Validation, etc);
- Personal targets.
Specific professional/technical requirements:
- Minimally MSc in a relevant discipline, like Pharmacy or Bio-Pharmaceutical Sciences;
- English required;
- Minimal 8 years of experience, of which 5 years relevant to this position (industrial setting/manufacturing and/or Quality Assurance area).
You will receive a contract till the end of the year. Desired startdate is august 5th.
More information about the Senior QA Associate / Senior QA Officer? Please contact Leonie Koomen at Leonie@heraklespharma.n or 06-1051 83 23.