MES Quality Lead

MES Quality Lead 

Location: Beerse

Duration: 12 months contract Hours: Part time (20 hours) 

Essential: MES experience within Pharma / Medtec, travel to sites in EMEA, 

The Janssen Supply Group, a member of the Johnson & Johnson family of companies, is searching for a Contractor - Lead – MES Quality Oversight for the QC Operations Execution Systems team.

The Role: 

MES Quality Oversight performs QA oversight for the MES (Manufacturing Execution Systems) relevant business processes.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.

Key Responsibilities:

• 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

• Drive quality process standardization and harmonization within the MES framework

• Escalate project issues to leadership to ensure areas of interdependency are appropriately accounted for and prioritized

• 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.

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

Qualifications & Experience

• A minimum of University/Bachelor’s degree in sciences (e.g., chemistry, biology, pharmacy, information technology, engineering). Master’s degree is preferred.

• 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.

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

https://www.jnj.com/

application process

We are looking to process the first round of applications within the next 2 working days.We do not accept applications via email.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.