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We are searching for the best talent for IM Transcend Program Quality Lead role.

Purpose: IM Transcend is a multi-year global business transformation initiative that will modernize our end-to-end business digital capabilities by harmonizing our disparate ERP ecosystem, standardizing our core business processes and products [across Commercial, R&D, Plan, Source, Make, Quality, Deliver, and Data], and enabling our integrated data strategy through a single SAP S/4 HANA instance.

Quality standards that need to be followed within technology programs originate from a variety of sources: regulators, internal quality standards, internal policies, product standards, procedural norms, etc.

The Program Quality Lead applies the specifications of the corporate and organizational Quality Systems and Quality Standards to ensure that the quality of processes and deliverables of programs continuously meet their specified corporate and regulatory requirements. In addition, the Program Quality Leader will be involved in the assessment of potential external partners and in the evaluation and tracking of remedial activities of such partners.

The PQL may be called up to manage Quality-oriented sub-tasks within a technology project, including but not necessarily limited to: supplier evaluation, validation, risk assessment, risk mitigation, audit follow-ups, etc.

The Lead will need to develop strong business partnerships across key stakeholder groups, including (but not limited to) the IM, Commercial, R&D, Quality, Regulatory, Enterprise Quality Central Finance program (CFIN), EPM, JJT, and Enterprise Sourcing.

You will be primarily responsible for:

Quality Management Framework

• Establishment of defined quality management framework for the program.
• Define quality practices for project or program
• Define and embed required quality-driven templates in the program
• Drive documentation of quality practices in SOPs (QM)
• Review and/or approve quality relevant deliverables (e.g. stage gate relevant content)
• Principle author of key quality-driven project deliverables (e.g. validation documentation functional risk assessments, etc.) in alignment with relevant compliance experts (via a Document Factory)

Ensuring quality execution for the Transcend program

• Monitor processes to ensure compliance with accepted framework, methodology, or quality standards (e.g. SDLC)
• Manage validation projects/sub-projects (PQM)
• Provide robust oversight of the risk management process
• Coordinate quality documentation/deliverables
• Work with the Testing Lead(s) to ensure testing adequately addresses program quality requirements.
• Ensure that testing is adequately documented to ensure reproducibility.
• Drive an efficient program quality framework, harmonizing the requirements from different frameworks
• Drive measurable continuous quality improvements e.g. % right first time through TQ reviews"

Establishing a Documentation Factory for the program

• Complete vendor selection (assuming RFP has already been initiated before the incumbent in in seat), in collaboration with procurement
• Define Documentation Governance Framework, Operating Model, Tools
  • Define documentation scope and standards
  • Select documentation tools and repository setup
  • Create documentation templates
  • Develop documentation plan and schedule
  • Define quality assurance/review process
  • Onboard vendor documentation team
  • Assign SMEs for content walkthroughs
  • Review and approve deliverables
  • Track progress and resolve issues
  • Handover documentation to BAU teams

Acting as the Program Quality “Advocate” with key stakeholders and as a Quality Consultant for the team

• Possess a high level current knowledge of the regulatory compliance landscape. Know whom to contact for deeper regulatory advice (e.g. ICFR, ISRM, TQ, BQ, Data Privacy etc.).
• Provide guidance to project teams on current program standards and quality practices. Be an SDLC SME.
• Develop and align on “Golden Templates” with the relevant Quality functions
• Collaborate and partner with the Quality functions, providing advocacy and influence for the program’s approach to quality.
• Maintain an active network with other quality managers and peers within compliance groups.

Qualifications / Requirements:

• Bachelor's/University or equivalent degree in Quality/Business/IT/Science or comparable experience. MBA preferred.
• Minimum 15 years of progressive experience in leadership roles within Quality, and ideally also Supply Chain, or large transformation programs.
• Minimum of 10 years of progressive experience with GxP regulated processes in the pharmaceutical industry, preferably Quality Assurance, Supply Chain, Manufacturing or HSE (Health, Safety & Environment).
• Hands-on experience of applying Business Quality (GXP) in an ERP setting, preferably using Agile methodology.
• Required experience of applying SDLC principles in an ERP setting.
• Minimum 3 years of hands-on experience working in CSV IT Projects.
• Deep knowledge of IM Quality across all functions required.
• Demonstrated hands-on project management/delivery required. Experience in management of project timelines and milestones in complex business environments required.
• A highly respected expert in the Quality Function.
• Ability to effectively lead and govern cross-functional decision-making bodies required.
• Good Technical Writing and GDP (Good Documentation Practice) skills as the PQM has to author major validation documents like Validation Plans, Reports and other documents. Additionally, knowledge in deploying standardized work processes, tools, and templates required.

OTHER:

• Requires proficiency in English (written and verbal) to communicate effectively and professionally.
• May require up to 20% of domestic and international travel.
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week.

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