MSAT LM DS Site Director (onsite)
Publication date:
18 July 2024Workload:
100%Contract type:
Unlimited employment- Place of work:Leiden
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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/.
Johnson & Johnson Innovative Medicine, Supply Chain is recruiting for a MSAT LM Site Director - Leiden, who has the responsibility for the management of the MSAT department in Leiden.
The MSAT Director manages a highly engaged world-class site MSAT team providing strategic leadership and direction aligned with the site, Large Molecules and Advanced Therapies network with the dedicated focus on:
- LCM - Technology transfer coordination at site / NPI Support
- PQ, validation execution (Process and Cleaning Validation)
- Process improvements execution
- Standards deployment, PAT, technology
The MSAT Director will report solid line to the MSAT LM Platform Lead and dotted line to the Site General Manager and have a strong connection with the MSAT Advanced Therapies Platform Lead and be a member of the site SLT. She/ He will lead a team of Managers, Scientists and Engineers (Cleaning and Process Validation Experts and Project Managers) across the Site Business Units in span of control of the site.
Being accountable for the Validation Masterplan and execution of related Performance Qualification, Life Cycle Management Process as well as Cleaning Validation. Being System Owner of Validation and PQ and therefore accountable for Regulatory Inspection for area of responsibility.
The MSAT Director/ is responsible for day-to-day PQ & Validation Management as well as related Project Execution, including supporting NPI or Life Cycle Management initiatives. In addition, he/ she will be responsible for the execution of standards and delivery of business results on site.
Responsibilities
The core responsibilities for this role are as follows:
- The MSAT Site Lead manages an MSAT team with focus on execution of Product Transfer /supporting Product Introduction for the Site, Life Cycle Management Process and cleaning validation, process improvements in support of technology and product technical life cycle management and deployment of standards.
- The MSAT Site Lead and his/her team are accountable for the Validation Masterplan and execution of related Performance qualification, and Process as well as Cleaning Validation.
- System Owner of Validation and PQ and therefore accountable for Regulatory Inspection for area of responsibility. This includes technical support in partnership with Quality on any regulatory audits and inspections and being the Spokesperson in Audits internal and external.
- Partnering with MAM and Production on Project Oversight of assigned projects.
- Partnering with Product Stream Leads and other MSAT platforms and COEs, site GM and BUs on project priorities.
- Single Point of Contact (SPOC) for Site MSAT needs responsible for managing MSAT team’s contribution towards manufacturing floor support, investigations of major/critical process deviations, impact assessments, process monitoring/continued process verification, /process improvements, process improvement projects, change management, and data analytics.
- Drives accountability of self and others and creates an environment of innovation and experimentation that facilitates creativity and idea sharing.
- Monitor technical process and product performance.
- Monitoring and continuous improvement of MSAT KPIs.
- Accountable for managing team in accordance with Site and MSAT priorities following the JSC Business Cascade (Budgeting, Resources).
- Motivates and inspires site MSAT team to drive significantly increased performance through technical innovation and change. Provides leadership and development to the team and ensures there is a diverse pipeline of high performing multi-skilled leaders of the future.
- Owns and executes initiatives and projects related improvement programs, implementation of new capabilities and capacity.
- Develops and deploys technology standards and its applications through assets and products.
- Drives a Credo-based culture.
- Handles all aspects of managing personnel, including hiring and terminations. Provides coaching and development opportunities. Evaluates performance and provides feedback. Implements disciplinary actions, as necessary.
Contact
Synthes GmbH