Global Head-Quality,Shirwal,ACG Pharmapack

7 days ago

india ACG Full time

/Primary Responsibilities/g

Strategic and planning
Work closely with APPL CEO and AAPL / NNPL leadership team and any other relevant stakeholders to develop the Quality and Regulatory Affairs Strategy for APPL across the globe
Cascade the strategy to all APPL locations across the globe.
Provide functional guidance to all departments to ensure delivery against Quality strategy.
Drive continuous improvement and innovation across all quality operations.
Survey the environment for latest developments in Quality management, quality systems and best practices around regulatory affairs.
Build and maintain networks with regulatory authorities in all geographies as relevant for APPL’s business needs.

Functional
Review, approve customer requirements and Regulatory Matters based on inputs provided by and approvals from business leadership (CEO), Head-Operational Excellence, Head Production, Head HR and Admin, Head SCM, Head Sales and Marketing, and other stakeholders.
Review and finalise detailing of the customer requirements in terms of activity level break down, interim milestones, timelines for various activities, projected risks, critical path activities, etc.
Prepare risk mitigation strategies/ action plans for each identified risk including credible alternate/ backup options and implement and ensure adherence to the same.
Conduct regular Review Meetings with the business leadership to monitor the progress on all project activities and identify necessary actions to ensure conformance with or make suitable changes to the overall execution plan.
Verify the detailed scope of customer compliances based on the material specifications, quality levels and timelines as agreed upon.
Assist the procurement team in understanding the technical and regulatory requirements of any item to be procured especially in case of new vendor development.

Internal Processes
Define policies, practices and Standard Operating Procedures (SOPs) for the operations and ensure adherence to the same by respective departments.
Define the quality assurance and quality control (QA/ QC) norms to ensure all manufacturing activities adhere to the expected quality standards.
Responsible for all regulatory compliances related to product and manufacturing.
Ensure that any amendments to the Quality agreements with customers/service providers are drafted correctly and are validated by the Legal team, before they are effective.
Provide assistance to various Manufacturing, Sales and Business Development functions in case of any issue/ escalation to ensure effective functioning of the Manufacturing and adhering customer requirements.

People development
Take overall responsibility for people development initiatives and building up in-house capabilities,drive a performance driven culture in the team by timely monitoring, review of performance parameters and feedback to the team members.
Contribute towards development of talent for the department by providing subordinates with adequate exposure and growth opportunities to enable readiness for higher roles.
Actively participate in HR initiatives
Develop digital capabilities within APPL
Identify and create clear succession plans and execute them on an ongoing basis

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