Senior Manager, Corporate Quality Policy

Title:
Senior Manager, Corporate Quality Policy

Business Unit:
Quality

Job Grade: G9

Location:
Baroda

Author Global Documents in partnership with functional area SMEs and business co-owners ensuring that global documents are designed to a comprehensive level, and agreed upon by stakeholders.

Responsible for working with corporate functions, influencing process, tool and template improvement and helping to facilitate alignment across multiple functional manuals.

Additionally, this role will ensure all documents authored are aligned to compendial, ICH, FDA and other regulatory guidance expectations. The role requires to work independently and manage multiple assignments simultaneously with business co-owners and functional key SMEs.

Author and fully manage the lifecycle (development, review, change control, execution, approval, effective status, training activities, revision, obsoletion, periodic review etc.) of global documents.

Ensure all written documents are aligned and confirmed to an approved document format, standards, style, methodology and terminology.

Work using Sun Pharma's eDMS system ensuring proper workflows are utilized with appropriate review and approval for all global documents.

Function as the SME and keep abreast of updates on the applicable health agency regulations and best industry practices. Provide technical and regulatory guidance with respect to global regulations to internal and external stakeholders ensuring overall quality and compliance.

Oversee and drive implementation of global documents with regulated market site representatives in order to direct and facilitate implementation and guide sites to overcome hurdles in implementation as required by effectively facilitating discussions to attain consensus between business stakeholders.

Ensure that target dates for updates on Global document implementation to regulatory bodies, e.g., FDA, are met by timely preparation and site data collection.

Monitor progress of commitments made to regulatory bodies and GxP consultants for Global document creation/revision ensuring the effective document availability within committed timelines.

Own, execute or support the projects and initiatives to enhance processes, compliance and the global document collection e.g., review of site global documents implementation practices and harmonization/reduction/simplification/enhancement of Global documents,

Support site deployment and implementation of process sustainability and effectiveness as a continuous improvement efforts.

Perform periodic assessment of global documents regarding implementation feedback, status based on site inputs, observations based on site self-inspections, corporate audit and regulatory inspections as well as update to regulatory requirements.

Act as a contributing member of the global document SPOC forum, ensuring consistent approaches to document development and site implementation as appropriate.

Develop and manage global documentation implementation packages, request and review site gap assessment forms when necessary.

Conduct and attend cross-functional meetings, quality management review meetings to present global document strategy, status, implementation plan and progress on continuous improvement approach for global documents life cycle management.

Support the upgrade/enhancement of enterprise electronic systems by ensuring timely communications to aid site preparedness, e.g., notification of approved status of system GSOPs, to enable alignment of site readiness to Go-Live target dates.

Carry out effectiveness checks of Global document implementation e.g., performing spot checks on site/function procedures to assess alignment against the requirements in the Global Documents as applicable.

• At least 15 years of experience, good knowledge of GxP regulations (US, EU, Health Canada, TGA, Schedule M, WHO, PIC/S, ICH, etc.) related to 6 quality systems, especially manufacturing, compliance, quality assurance and QMS.
• The candidate should be a dynamic result driven and performance oriented professional with excellent competencies of collaboration & empowerment,…