Head- Quality, APAC

Purpose

JOB DESCRIPTION

• Define, establish, and monitor quality management systems at EM&S APAC as per cGMP and Sanofi Global Quality policies to ensure the quality of products DP and DS.
• To ensure regulatory compliance for domestic and export Drug products and API manufactured by External Manufacturing sites of Sanofi.
• Collaborate with Quality Operations Cluster Head Quality Operations for rolling-out best practices and governance for CMO Quality Management within the EM&S APAC Quality network, ensuring quality oversight.
• Lead and coordinate quality and compliance of transversal projects for the EM&S APAC.
• Ensuring the renewal, registration, and maintenance of product dossiers & regulatory status for export and local markets for drug products and Drug substances.

Key Areas

Quality Management System

Define, Implement & Maintain Quality management Systems for EM&S APAC products.

Ensure the compliance of the EM&S APAC quality system to the GOPs.

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

Oversight of the CMOs and other third parties managed by EM&s India

Perform risk ranking for CMO's as per the Sanofi Directive 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 QTA and to EM&S APAC activities and define the mitigation plan to address these risks

Closely monitor CMO performance assessing KPIs, audit outcomes, responsiveness and other quality indicators

Quality Agreement

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

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 the process validation document for compliance and ensure that commercial batches are released in compliance with specifications.

Audit Management & Periodic Quality Risk Assessment

Perform a Quality Risk assessment as necessary when the audit resulted with critical observation

Follow-up the implementation of the CMO audit CAPAs

Deviation / Investigation Management

To achieve closure of the investigations within timeline defined by ensuring regulatory, quality compliance and put CAPA in place. To evaluate risk and escalate as per Sanofi GOP and perform assessment and CAPA.

Supplier Exit Or Change Of Supply

Ensure the QA aspects (for example Stability, APR / PQR management etc.) associated with withdrawal or termination of a CMO.

Product Dossier Management for Export Products for Drug Product & Drug substance

Ensuring the renewal of product dossiers of DP & DS in timely manner.

Ensure to implement and follow GRA processes for all export product dossier management.

Regulatory Compliance

Ensure that Maintaining the Regulatory status at External Manufacturing sites – preparation of applications – to procure new manufacturing licenses / additional products / surrender of license.

Ensure that the critical regulatory queries for local and export markets responded on 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.

Support to Business development projects. Participate and support EM&S / global entities for Selection and Approval of CMO Or Due diligences (for acquisition of new products)

Ensure adequately staffed quality unit, define individual roles and responsibilities, Provide technical support to the sites and quality agents to resolve issues related to quality.

Identify key associates and their training / developmental needs, organize to provide requisite training and monitor their development to ensure that they are developed for taking up higher responsibilities.

To ensure the compliance of artwork Sanofi global guidelines and the general requirements as per Sanofi approved standards and SOP.

In absence the responsibility of Operation topics is delegated to Head QA and regulatory topics are delegated to Regulatory Managers.

Pre-requisites

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.

Skills for Effective communication, networking, interpersonal relations, assertiveness, and leadership.

Qualifications

B.Pharm / M.Pharm / Ph.D / MS / MSc

15 to 20 years total experience in the Pharmaceutical Industry out of which at least 10 to 15 years should be in Quality Function and rest in one more department like manufacturing or formulation department.

Minimum 4-5 Years' Experience In Senior Leadership Role

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Skills Required

Risk Assessment, Technology Transfer, audit management, Regulatory Compliance