Director Quality Assurance Clinical Operations

il y a 1 mois

Antwerpen, Belgique Johnson & Johnson Temps plein

Essential tasks and responsibilities:
Leading the Operational QA groups in the pilot plants of Beerse, Schaffhausen and Leiden Advanced Therapies to ensure that the GMP activities as manufacturing, packaging and labelling of Investigational Medicinal Product (IMP) can be carried out as required by legislation and ensures quality and compliance of the IMP products.

Directly supervises teams that are responsible for Quality Assurance activities for Pilot Plants and for Qualification and Validation. The teams are located in Beerse (BE), Leiden (NL) and Schaffhausen (CH).

Acting as the Site Quality Head for the Advanced Therapies Pilot Plant Leiden.

Main responsibilities:
Quality Leadership
- Ensure that adequate resources are available to support business needs.
- Ensure that GMP R&R’s are clearly described for all employees and that organisation charts are available.
- Manage the quality organization in such a way that the departmental objectives are met.
- Support, coach, develop team in reaching their quality, business and personal objectives.
- Establish and maintain effective working relationships with the different business partners to ensure alignment of objectives and deliverables.

Operational Quality Performance
- Act as an expert resource in assessing and maintaining quality and compliance levels.
- Continuously challenge the status quo and lead the development and implementation of breakthrough innovative initiatives that deliver sustainable improvement in organisational, quality and compliance performance.
- Represent quality on different forums, steering committees, task forces.
- Ensure quality oversight of the operational activities by documented QA approval of GMP documentation and support/participation in the different quality review meetings.
- Ensure and manage the implementation and execution of the different quality system processes.

Management of Quality Activities
- Ensure that deviations/complaints are timely and properly investigated such that the internal and external customer expectations are met.
- Support in-depth investigations by providing technical, quality and compliance expertise.
- Ensure that adequate CAPA’s are defined for investigations with potential quality impact.

Management of Inspections
- Support the preparation, execution and follow-up of inspections and audits.
- Act as a quality spokesperson during inspections/audits.
- Ensure and support the execution and reporting of internal audits according to the internal audit plan.

Acting as Site Quality Head for the ATP Leiden
- Be the SPOC for communication with IGJ.
- Approve and sign all oversight documentation related to the site such as QSMR, Licenses, Site Master File.

Magnitude and complexity:
You are responsible for the QA oversight of 4 separate pilot plants: Pilot manufacturing Beerse, Clinical Packaging & Labeling Beerse, Fill-Finish Pilot plant Schaffhausen and Advanced Therapies Pilot Plant Leiden.

You will manage 4 Sr Managers with each additional direct reports. In total, the team consists of 25-30 members, potentially extended with contractors.

The type of products that are being produced in these plants are from the AT, LM, SM platforms and can be solid, liquids and sterile products.

Not meeting the Q&C requirements for these pilot plants might result in suspension of licenses and GMP certifications and could also potentially jeopardize the execution of the clinical trials.

**Qualifications**:

- Master’s degree in a life science study or equivalent experience.
- More than 10 years of experience in a pharmaceutical industry with demonstrated capability in quality leadership roles.
- In-depth understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes.
- Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation, legislations related to Clinical Trials and cGMP regulations (Eudralex, ICH, Ph.Eur., USP, etc) at global, regional and national levels.
- Experienced spokesperson for Health Authority (e.g. EU and FDA) inspections.
- Strong analytical thinking, decision-making and leadership skills.
- Excellent verbal and written communication skills to negotiate and communicate with external and internal customers and partners.
- Ability to define strategies and translate them into actionable items and an action plan.
- Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization, with the ability to manage/master complexity and to act as a sponsor for change.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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