Job Detail

Role: CMO Lead (North / South)
Reporting to: Head External Supply
Location: Bangalore (South)
Basic Requirements:
Education: B Pharma / M Pharma or BE with around 20 years of experience
Has exposure to Formulation Plant operation / quality / production / operations excellence / EHS
Contract Manufacturing experience is preferred
Has experience in working in manufacturing Sites

Responsibilities:
Job Purpose:
To ensure that products are delivered from cluster sites as per commitment with right standards of quality, cost, EHS and compliance.

Key Responsibilities:

To oversee cluster of CMO sites in the North / south region, with MIP / PIP reporting to him for delivering of finished products and ensuring that all GSK standards (Quality, EHS and Compliance) are met.
To act as Cluster Head and will be responsible for overall deliverables of the CMO sites
To monitor Performance Dash board and participate in meetings with External Supply Head and External Supply QH periodically to discuss performance
To visit CMO sites from time to time and monitor the performance of the product manufacturing
To ensure Implementation of GSK QMS requirements at contract sites and to ensure that product is getting manufactured at the site as per cGMP requirements
To anchor the regulatory compliance at contract sites and to ensure no disruption of supply & no regulatory sanctions
To ensure and handhold PIPs for all time ESA audit readiness. Regularly get involved in Audit Management. He is expected to drive all the audits for eg. ES Audits at site / E&Y / KPMG / EHS, etc.
Perform QMS gap analysis and follow-up for effective QMS implementation along with OQ Leads from Quality Team
He will also lead a team comprising of PIPs, ES Technical, Key Account Manager and EHS & needs to work closely with OQ Leads ensuring CMO oversight. Provide leadership to set objectives and ensure performance standards are met, developing standards of accountability and reporting of Direct reports.
Monitor wastages/Write off destruction process and take accountability as per GSK norms
Monitor Environmental, Safety and Health indicators of Site. Report Safety incidents to the ES-EHS
To support timely release and delivery of finish products by timely resolution of quality related issues
To ensure contract sites continuously improve contribution to business performance management.
Handle quality issues related to raw and packing materials, review and approve destruction or return of defective raw and packing materials to vendor
To assist in smooth Product Transfers and meeting on FSTM
To run the cost saving projects as per the GPS Guidelines
Interact with SLT / Plant Head of CMO on regular intervals
Timely escalate issues to Head ES for resolution
Oversee employee compliance child labor, PF payments, Employee discipline (as per factory act)
Prepare Risk charter for Site and discuss with ES Head on six monthly basis and participate in RMCB and other ES governance meeting
Assist in the development and implementation of the Sites direction and long term strategic plan.
Develop the operating and capital budget for manufacturing and packaging departments.
Communicate key findings and best practices to Senior Leadership Team and Site Director.
Responsible for delivery of CTP with Quality, Cost, EHS and Compliance at a cluster level.
Monitor overall business performance of cluster sites on parameters like - CTP, OOS, Safety, Environment, Cost, Wastage.
Responsible for product quality , quality processes and systems adherence.
Focus on remediation sites and ensure that the remediation process is implemented on time and within the desired cost.
Review and mitigate site level risk charter
Control cost of waste at cluster level.
Review site CAPA action plan.
Coordinate EHS audit with EHS Auditors.
Ensure AMR applicability and Site readiness
Keep track of Drug and cosmetic act, Industrial registration and factories act, Pollution and control legislation, Goods service tax laws and custom laws,
Implement quality improvement plan for respective site level