Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Quality Assurance Manager - GxP - CAPA - Pharmaceuticals

Eingestellt von Elevate Direct

Gesuchte Skills: Design, Aris

Projektbeschreibung

QUALITY ASSURANCE MANAGER/BEERSE, BELGIUM/9 MONTHS CONTRACT/UP TO 74 EUR PER HR

The Manager is accountable for a larger section of the procedural framework and is responsible for ensuring that GxP and similar requirements are adequately described. The Manager has content knowledge of the area he/she is accountable for and works with partners form the business and other quality functions to ensure the process meets their requirements and aligns with their operations including the training development and roll-out. He/she is responsible for implementation, improvement and design projects related to the procedural framework for GxP and business processes, either as leader or key team member and has to design and implement Role Risk based training plans.

The Manager (BPM) will contribute to the development of a quality system that enables the Global Clinical Development Organization (GCDO) to conduct clinical trials in an efficient and compliant way, resulting in clinical programs that allow for seamless registration of the compounds.

ACCOUNTABILITIES:

The BPM will lead or participate in improvement projects to describe the new desired state of processes for compliance. Gather and analyze metrics, CAPA and other performance data of the existing process, describe requirements and develop with the partners to be processes.

1. The BPM will oversee detailed process development, procedural document development, training development in collaboration with the responsible functions to ensure content and requirements of the design are fully transferred and implemented. Collaborate with responsible leaders to ensure planning is met, providing input to the functions in a Matrix.

2. The BPM will collaborate with other BPM Managers to plan and prioritize projects. Maintain relevant planning tools.

3. The BPM will create high level process maps in ARIS and provide sufficient detail to ensure all levels of the process can be worked out. Create detailed process flows for selected projects. Review detailed process flows and approve through agreed stage-gate and versioning approaches. Develop the associated training material and have it deployed to the relevant target audience applying a role risk based training methodology.

4. The BPM can lead or participate in the development of departmental processes and tools to improve own and departmental work

5. The BPM will lead by example and ensure compliance systems are maintained and accurate (training plan, time registration, corporate compliance programs, etc)

6. The BPM will participate in partner organization leadership team meetings and individual meetings to ensure processes meet their requirements and keep them informed of progress.

The BPM is a professional function that contributes to the clinical development process in J&J R&D supported by BRQC. Decisions made and problems solved will involve process and training development, working with various stakeholder groups both within BRQC and outside of BRQC, providing technical and content expertise to teams, reporting and summarizing to cluster leads and management.

EDUCATION:

Masters degree or BS/BA with minimum of 8 years experience in a medium to large scale Matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences; Exceptional written and verbal communications skills;

Experience in R&D process requirements to successfully drive Q experience of the overall drug development process is an asset

Experience in quality activities, including audits of clinical investigative sites, compliance support and audits of regulatory submissions is an asset

NON TECHNICAL SKILLS AND ADDITIONAL DETAILS

Problem solver

Proactive strategic thinker

Strong leader and collaborator

Highly committed to quality

Flexible and persistent

Good conflict handling/negotiation skills

Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks

Excellent communicator and presenter, with excellent interpersonal skills and diplomacy

Excellent knowledge of English is required

Proficient in Microsoft Office applications

Able to create win-win situations with internal and external partners

Stakeholder contacts are frequent and require excellent interpersonal skills and diplomacy

Knowledge of the corporate structure and culture

THE COMPANY

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.

Projektdetails

  • Einsatzort:

    Beerse, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    9 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung, Medien/Design

  • Skills:

    design, aris

Elevate Direct

use Date;