Director Schaffhausen MES Deployment

Job Detail

Job-ID 302296

Job-Beschreibung

Johnson & Johnson is currently seeking a Schaffhausen Manufacturing Execution System (MES) Project Lead to join our team located in Schaffhausen, Switzerland.At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.The successful candidate will be responsible for leading the site project team to deliver the major site transformation project in implementing a Manufacturing Execution System for the manufacturing operations in Schaffhausen using new integrated technologies called Next Gen Manufacturing platform. This will be a phased project involving conversion of all manufacturing batch information/records from a document-based system to a full integrated digital system with workflow management. The system will be integrated to multiple key systems (e.g. Manufacturing equipment, SAP, LIMS, Truvault etc.).ROLE:

Lead & deliver MES Project for Schaffhausen site
Primary contact between project team, sponsor and steering committee
Ensure project team representation is aligned with project objectives and delivers integrated MES solution for Schaffhausen business
Project expert and project manager for the Schaffhausen site
Champion for project execution

RESPONSIBILITY:

Own overall execution and program delivery within scope, schedule, budget and quality/regulatory requirements.
Responsible for verifying planned changes and gaps with local stakeholders / users
Responsible for project Risk Mitigation planning
Maintain a strong relationship with DOTS, to drive E2E deployment excellence for systems, and JJT, to co-develop new technical capabilities into Next gen Manufacturing platform
Confirm, monitor and deliver all Final Project Objectives (FPO’s)
Overall accountability and responsibility for successful and on time and in budget execution of deployment, across all work streams and functions
Manage the deployment to ensure timely/high quality deliverables
Own project planning, resourcing, monitoring and adherence to plan
Maintain and control project budget
Work with Cross Deployment Leader to provide clear and consistent communications to Steering Committee and Project Sponsor & escalations
Ensures conformance to the Global Template and deployment methodology
Partner with the Business Lead to ensure that the end-state, integrated, solution meets business needs across all impacted functions (end-to-end)
Strongly collaborate with the Next Gen MES Deployment Lead and Excellence Lead in DOTS to define and execute deployment standards
In alignment with Deployment Excellence lead setup concepts to efficiently and effectively deliver the MES execution with highest RFT
Manage template changes/ customization in response to business statutory & regulatory needs
Ensure integration of functional experts and business SME’s, in order to establish a holistic project execution team
Provide proactive communications about project activities to key stakeholders, managing internal (Site) and external (global organization) stakeholders
In strong partnership with Business Lead, drive change management to align the organization with new business capabilities

Minimum of a Bachelor’s degree in science-based discipline is required. A Bachelor’s or higher degree in Life Sciences discipline, Pharmacy or Chemical Engineering is preferred.
Minimum 10 years of experience in operations and project management in Pharmaceuticals.
Knowledge of the applicable regulations and regulatory processes.
Demonstrated knowledge of Good Manufacturing Practice (GMP) regulations; proven understanding of GAMP and SDLC requirements is preferred
Knowledge in Quality and/or Regulatory Compliance field, preferably in Pharmaceuticals is considered an asset.
Ability to work across organizational boundaries in a global matrix organization, through influence, negotiation and partnering for changes requiring buy-in from all stakeholders at all levels.
Strong decision making and problem solving competencies
Strong conceptual leadership skills
Knowledge of Automation and IT related systems in regulated environment
Language capability – Must be proficient in English & German (oral and written).

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong