Manager Quality Assurance

il y a 5 jours

Beerse, Flandre, Belgique Randstad Temps plein

For Johnson & Johnson, we are looking for a Quality Assurance Manager.

Scope of this role:

Provide QA support for External Manufacturer, based in Denmark. Lead QA objectives for 1 specific ongoing technology transfers, inspection readiness, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecules (drug substance manufacturing).Support the External Quality account owner on tech transfers and projects as assigned.The position requires solid knowledge in all quality systems concerning the manufacture of biological drug substance and extensive knowledge of Quality Assurance, Quality Control and Compliance and technology transfers.Demonstrated ability to operate with a minimum of supervision. Demonstrated ability to take ownership for and lead the resolution of complex Quality and Compliance issues.Position requires travel to External Manufacturer's sites (Denmark) to provide cGMP assistance and quality oversight. This fulltime job is open to European based candidates and is mostly remote with (up to 15%) travel to Denmark. You will provide these services to J&J via Randstad Professionals - Life Sciences Vlaanderen.
key responsibilities Serve as a contact point within the QA organization of other departments of both Janssen and the external manufacturer with respect to quality relevant subjects. Build relationships and influence external partners to continuously enhance quality culture and business excellence.Provide QA oversight for technology transfer including process validation, method transfer and cold chain implementation.Review and approve validation related documentation authored by both the external manufacturer and Janssen.Perform review of equipment and facility qualification, environmental monitoring, technical documents, supplier qualification, raw material specifications, analytical methods, sampling plans, and master batch records to ensure products and processes comply with cGMP requirements.Conduct quality investigations and provide timely input to support close out with a minimum impact on the supply chain.Lead the development of corrective action plans and monitor implementation.Review batch documentation of products in scope prior to their release by the external manufacturer's quality unitCoordinate change control documentation and approval process.Ensure the timely supply of Product Quality Reports (PQRs) from the external manufacturer according to schedule. Carry out a documented review of PQRs.Support JJRC audit and regulatory inspection readiness at the external manufacturer for Janssen products. Support response to and follow-up of audit outcomes.Pro-actively identify risks and potential issues and delays and, where possible, resolve them. Where resolution is not possible, escalation to the relevant level of management is necessary.Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time.Ensure that all relevant QA related concerns at the external manufacturer sites are raised to the External Quality Account Owner.
qualifications Bachelors Degree in engineering, science, or an equivalent technical disciplineWork experience: 10+ years relevant industry experienceExtensive (5y) knowledge of GMP, specifically biological drug substance experience is preferred (QA and/or production).Experience managing quality oversight for production and technology transfer programsAble to connect easily, team worker, able to manage across culturesAble to work independently while managing stakeholders, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are requiredExcellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.Ability to quickly process complex information and make critical decisions with limited informationProficient in written and spoken EnglishExcellent computer proficiency e.g. MS Office, Quality SystemsAmount of travel: up to 15% of travel required.
key benefits You will be contracted via Randstad Professionals. For Belgium based candidates: contracting as an employed consultant or freelancer. For European based candidates: freelance assignment. Interested in this assigment? Include your motivational letter answering the following questions: Specify your degree (min. Bachelors Degree in engineering, science, or an equivalent technical discipline).Specify your work experience: 10+ years relevant industry experienceSpecify your extensive (5y) knowledge of GMP, specifically biological drug substance experience is preferred (QA and/or production).Specify your experience managing quality oversight for production and technology transfer programsSpecify your excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.Are you able to travel: up to 15% of travel required to Denmark location?

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