Manufacturing Quality Lead

  • Location: BEERSE
  • Type: Contracting
  • Job #19820

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Manufacturing Quality Lead
Location: Beerse

Scope of work:

In this role you perform QA oversight for the MES (Manufacturing Execution Systems), relevant business processes supporting the QC Operations group as well as provide QA and compliance mentorship for Global MES initiatives and projects. You are accountable to support the implementation and maintenance of the Q&C Vision in decision making process.

The role is accountable to provide operational quality oversight for MES and ensures maintenance of the right level of compliance of MES platform business usage

 

  • Operational quality oversight entails:
    • Establish and provide leadership to ensure quality and compliance is maintained in MES processes during execution and deployment.
    • Responsible for leading any MES system’s deployment from a Quality Process perspective, according to system roadmap
  • Ensure all activities are executed according to expectations
  • Ensure project timelines and deliverables are met
  • Drive quality process standardization and harmonization within the MES framework
  • Promote stakeholder engagement
  • Escalate project issues to leadership to ensure areas of interdependency are appropriately accounted for and prioritized
  • Ensure oversight of user accesses to critical roles.
  • Prepare and Lead MES system’s Quality Management Review meetings, CAPA and Change Control Boards
  • Responsible for improving the key MES system GxP processes between the sites (user access review, role design, Exception handling, Release by exception, Auto closure, Batch Record Review, Master Batch Record verification) by connecting the QA users across the different sites.
  • Act as Quality approver for any global document linked to MES (Examles; MES incident management, MES Change Management).
  • Act as Quality approver for any global Investigation, CAPA or Change Control related to MES systems.
  • Maintains MES system’s audit readiness. Support Periodic Review exercises led on MES systems.
  • Facilitate System Forums/Community of Practice meetings. Lead decision making processes for above site Quality processes in partnership with site Quality teams

 

The candidate will be collaborating with Quality, Make, IT, Technical Quality and leadership in the Enterprise, Global and site organizations.

The successful applicant is able to provide leadership, take balanced and risk based quality decisions in the space of Manufacturing operations as well as in the execution system space.

 

Who are you?

  • A minimum of University/Bachelor’s degree in sciences (e.g., chemistry, biology, pharmacy, information technology, engineering). Master’s degree is preferred. Or equivalent in experience
  • Generally requires 10+ combined years of experience in Manufacturing, Quality Assurance, Quality Control, Validation or Engineering in vaccines/pharmaceutical industry. Solid understanding of the business environment inside a quality organization, across various roles (e.g., quality operations, quality control, quality systems, etc.) is preferred.
  • Proven knowledge of applicable regulations is required. Working experience within an FDA/EMA GMP (Pharmaceutical, Medical Devices) regulated environment is preferred. Familiarity with ISO requirements.
  • Working knowledge of Quality systems such as: Investigation/CAPA, Change Control, Document Management, Management Review process, etc. required.
  • Strong leadership/facilitation skills and ability to build respectful and productive partnership relationships with peers. Should effectively influence/negotiate at all levels of the organization. Independent thinking. Pragmatism. Ability to zoom-in and out.
  • Working experience in navigating and dealing effectively within a matrix organization, managing complexity, engaging and collaborating with multi-disciplined teams across boundaries and influencing without line authority, including remote team members.
  • Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adaptability required.
  • Results oriented with strong track record of success in delivering on objectives. Sense of urgency and ability to zoom-in / zoom out.
  • Conflict resolution and problem solver. Results and action oriented and highly collaborative. Ability to act independently and know when to involve/collaborate with others.
  • Project Management skills and experiences. Knowledge of Project methodologies and process excellence.

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

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