Senior Quality Assurance Manager

Région
Beerse
Publication
mercredi 11 octobre 2017
Date limite
samedi 11 novembre 2017
Réf
73E5AXPE-BE
Contact
Andrea Baetens
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Senior Quality Assurance Manager Organisation description:

Interested to develop your career as a Senior Consultant in Quality Assurance at XPE Pharma & Science?

As Quality Assurance Expert you are accountable for a larger section of the procedural framework and for ensuring that GxP and similar requirements are adequately described. You are accountable for the content knowledge of the area you work in and you will work with partners form the business and colleagues of other quality functions to ensure the process meets their requirements and aligns with their operations including the training development and roll-out.

Your task will be to design, improve and implement projects related to business processes and the procedural framework for GxP, either as leader or key team member and has to implement a risk based methodology, both on the process as well as on the training side (role & risk based training plans).

Job description:

Process Alignment & Training Support:

1. You 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.

2. You 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.

3. You collaborate with other QA experts to plan and prioritize projects. Maintain relevant planning tools.

4. You 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.

5. You lead or participate in the development of departmental processes and tools to improve own and departmental work.

6. You lead by example and ensure compliance systems are maintained and accurate (training plan, time registration, corporate compliance programs, etc).

7. You participate in partner organization leadership team meetings and individual meetings to ensure processes meet their requirements and keep them informed of progress.


Decision Making & Problem Solving:

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.


Reporting Relationships:

As QA Expert you are functionally aligned to the Head of Quality Management within BRQC, or one of his/her delegates. You will be assigned the Quality Management - BPM training curriculum.


Profile:

Position Qualifications:

You have a Master 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&D area is required. Requires knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques as well as adult training development expertise.


Related Experience:

  • Project Management Skillset
  • Ability to interpret data to develop action plans to improve business;
  • Must have strong personal leadership with demonstrated competency interfacing with all levels of the organization including senior leaders;
  • Strong networking and relationship building skills;
  • Ability to create an open and inviting environment;
  • Embraces generational differences
  • Exceptional written and verbal communications skills;
  • Ability to translate data into information and strategies into executable action plans;
  • Ability to independently plan, organize, coordinate, manage and execute assigned tasks;
  • Experience of quality related business processes and practices; experience of the overall drug development process is an asset.


General Skills:

  • Problem solver;
  • Proactive strategic thinker;
  • Strong leader and collaborator;
  • Highly committed to quality;
  • Flexible and persistent;
  • 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;
  • Stakeholder contacts are frequent and require excellent interpersonal skills and diplomacy.
Offer:

Why work as a consultant for XPE Pharma & Science?

• XPE is a part of Adecco, one of the Top 5 companies within the 'Great Place to Work' ranking

Dynamic colleagues with passion and drive

• The opportunity to develop yourself, your competences and skills within our organization

• An interesting salary with extra-legal benefits. We offer meal vouchers, group- and hospitality insurance.




Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713