Sr. Manager - CMO (ROW) Lead

ROW Lead is a highly experienced professional responsible for define establish, and monitor quality management systems at as per cGMP and Glenmark Quality policies to ensure the quality of drug products.

ROW Lead is responsible to ensure regulatory compliance for Drug products manufactured by External Manufacturing sites at and for RCIS, Latum APAC and MEA regions

ROW Lead has to ensure the renewal, registration, and maintenance of product dossiers & regulatory status of drug products.

Product Due diligence:

Ensure product due diligence and approval within stipulated time and timely new launches.

Quality agreement (QAg):

Establish Quality agreement between Glenmark and CMO's: Facilitate negotiations and ensure valid Quality agreement in place and updated whenever there is a change in relevant sections of QAg

Quality management system:

Define, Implement & Maintain Quality management Systems.

Ensure that local regulatory requirements and specificities are managed in alignment with the Global quality roadmap.

Oversight of the CMOs:

Perform risk ranking for CMO's as per the Glenmark procedure and define the mitigation plan associated for medium and high risk CMO

Escalate any Quality issues as per the Global procedures.

Identify proactively any risk related to the CMO compliance to regulations and QAg and define the mitigation plan to address these risks

Technology Transfer:

Ensure smooth manufacturing/analytical technology transfer through close working with transferring site and receiving site

Ensure timely approval activities related to review and approval of transfer protocol, assessment of site laboratory readiness, sharing of methods, standards, test samples etc. as applicable.

Release of product:

Ensure timely approval of commercial batches is released in compliance with specifications.

Deviation / Investigation Management:

To achieve closure of the investigations within timeline defined by ensuring regulatory, quality compliance and put CAPA in place.

Regulatory and compliance

Ensure that Maintaining the Regulatory status at External Manufacturing sites.

Ensure that the critical regulatory queries for local and export markets responded in a timely manner.

Product Dossier Management

Ensuring the renewal of product dossiers in timely manner.

Regulatory Compliance:

Ensure that Maintaining the Regulatory status at External Manufacturing sites.

Ensure that the critical regulatory queries for local and export markets responded in a timely manner.

Regulatory Authorities Inspection:

Ensuring timely completion of the compliance to the local and export regulatory audits of the contract manufacturing sites.

Act as SME submission of Finished Product Samples/ working standards to Reg. Authorities when asked for Follow-up and replies to complaints received.

Artwork Management

To ensure compliance of artwork and the general requirements as per SOP

Knowledge, Skills & Competencies:

Sound Knowledge on Current GMP requirements of local and various international regulatory agencies, Drugs and Cosmetics Act and Rules, Pharmacopoeias, and ICH guidelines.

Exposure to regulated, semi regulated markets and experience of handling regulatory audits.