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Sr. Manager
Il y a 3 mois
The Janssen Supply Group, a member of the Johnson & Johnson family of companies, is opening a position for a Sr.
Manager - Platform Data Governance & Integrity Lead for the design, deployment, and sustainability of the Pharm Data Governance & Integrity Process.
Position can be based in any of our Operating Companies globally.- *This role can be filled fully remote, hybrid or fully onsite. _
**While we observe the regulatory landscape evolving in setting expectations towards the implementation of Data Governance processes to guarantee sustainable and effective Data Integrity controls and measures as part of the company quality management framework, we are or adding some global Quality resources for driving the design, implementation, and sustainability of a risk-based data governance framework and the linked investment plan.
Key Responsibilities:
The Sr.
Manager - Platform Data Governance & Integrity Lead is responsible for the design, deployment, and sustainability of the Pharm Data Governance & Integrity Process, as well as for driving the strategy towards data integration optimization and control.
In the initial phase, the role will be leading in the design, shaping and deployment of the risk-based data governance framework while defining the investment plan.
In a later stage, towards sustainability, the role will migrate into taking full responsibility in the maintenance and continuous improvement of risk-based data governance framework, and in the execution of the investment plan per platform in collaboration with MAKE department.
Platform Data Governance & Integrity Lead entails:
- Platform Data Integrity SPOC
- Owns communication and change management framework in platform
- Accountable for the designs and maintains the Data Governance framework
- Provides initial train the trainer on Data Governance framework and owns the linked training framework adopted per platform, in support of the continuous knowledge management
- Accountable for maintaining the Data Integrity procedural framework adherence in platform, and supporting in the extension of the framework to the entire Pharm segment
- Accountable for implementing the data integrity framework in the platform: including assessment, risk based evaluation, control strategy definition and implementation, investment plan, and follow through execution
- Accountable for the site Process / Data flow mapping pilot & scaleout in platform, to unveil all sources of data integrity variability and vulnerability
- Accountable for a sustainable knowledge management framework in platform
- Accountable for enabling & empowering Critical Thinking & Risk Management as part of Data Governance & Integrity in platform to ensure active risk management, taking all aspects of patients safety & product quality into account
- Accountable for driving a sustainable Data Integrity gap remediation, leveragability & continuous improvement in platform
- Accountable for the data control strategy design, implementation, maintenance and monitoring in platform
- Accountable for supporting the site quality Data Integrity remediation lead in remediation plan design/approval as part of the global investment plan and for enabling a bidirectional handshake confirmation with the Pharm DI council
- Accountable for ensuring sustainability towards data governance through kpi monitoring, competency management, continuous monitoring & improvement and strong connection with pharm DI council
- Accountable for the codesign and rollout of the strategy towards data integration in platform, to enable more automated data collection for lowering data integrity vulnerabilities
- Accountable for defining in platform the nonpart11 compliant equipment investment plan and budget, and for executing upon the plan
- Accountable for defining and collecting KPI to support Metrics & platform QMR
The role is able to provide leadership, take balanced and risk based quality decisions in the space of Quality Data Governance.
Qualifications:
- 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+ years of experience in equivalent roles, within Quality Assurance, Quality Control, Validation or Engineering in 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 Data Integrity regulations is required. Working experience within an FDA/EMA GMP (Pharmaceutical) regulated environment is preferred. Familiarity with ISO requirements.
- Working knowledge of Quality systems such as: Risk Management, Investigation/CAPA, Change Control, Document Management, Management Review
