JJ
Associate Director in R&D Neuroscience at Johnson & Johnson developing precision medicines for complex brain health challenges. Collaborating with cross - functional teams to drive implementation of innovative strategies.
About the role
- Director responsible for leading the Incoming Materials program transformation at GSK. Harnessing technology and data within pharmaceutical manufacturing to improve processes.
Responsibilities
- Lead the Incoming Materials program team which is a matrix team to deliver the strategy and execution plan for the transformation
- Define and detail the GSC Incoming Material standards and strategy leveraging the best practices on harmonized data standards and common testing methods based on the Pharmacopeial standards.
- Work closely with the ERP Master data management and LES design teams to ensure clear requirements and catalogs are defined and built ready for the implementation phases.
- Define a roll-out methodology for the new processes and standards that can accelerate the delivery across the GSC sites.
- Working with the LES program teams translate the roll-out methodology into detailed implementation plans for the impacted sites.
- Develop the training and communication deliverables to manage the transition from the current state into the future state design.
- Define the future state Business As Usual (BAU data and test method update processes including change request processes and defining the appropriate governance model that will support this.
- Develop and ensure consistent and harmonized Master data structures in QC platforms are maintained across the systems and sites in alignment with Data Integrity and Regulatory requirements.
Requirements
- Degree in a Science, Computer Science, Chemistry or other related discipline
- Expert user for one or more laboratory applications including chromatography data systems (such as Empower) and laboratory information management systems (such as Labware or LabVantage)
- Significant experience in pharmaceutical laboratory testing activities, Analytical methods and instrumentation.
- Experience working with the Pharmacopeial standards
- Experience in Data management, Data Governance and reporting/ analytics.
- Ability to create a healthy, engaged and inclusive working environment that is sustainable over time.
- Organize, manage, and direct a complex variety of activities, people and tasks based at multiple locations globally, prioritizing conflicting demands in a measured, business focused way.
- Ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers to achieve business goals and objectives
- Ability to analyze complex data/information/scenarios and make rational, risk based decisions which are communicated and/or escalated clearly and confidently.
- Addresses challenges to Quality and compliance decisions/positions in a knowledgeable and assertive manner.
- Excellent interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels of management and peers.
- Excellent consultative, listening, communications and analytical skills
- Must be flexible, adaptable and a strong team player
- Negotiation and conflict resolutions skills
- Technical breadth in order to build integrated program plans.
- Strong knowledge of GPS desirable
- Technical Business and Technical expertise in pharmaceutical computer systems delivery.
- Broad Knowledge and experience to understand the links and identification / management of Risks between the Business, Technical, Operational and Support aspects of project delivery.
- Experience with Data management, standards and governance
- Experience and knowledge of program and system life cycles.
- The ability to plan effectively in order to deliver sustainable business change programs
- Breadth in quality systems principles and practical application of QMS and Regulatory submission filings in multiple complex markets.
- Ability to motivate highly skilled and trained individuals.
Benefits
- Health insurance
- Flexible working hours
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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