Senior Manager, Corporate Quality Policy

Responsibilities

• Author and manage the full lifecycle of global quality documents, including development, review, change control, and periodic review.
• Ensure all global documentation aligns with compendial, ICH, FDA, and other international regulatory guidance.
• Partner with functional SMEs and business owners to design comprehensive documents and facilitate alignment across multiple functional manuals.
• Act as a Subject Matter Expert (SME) on health agency regulations and industry best practices to provide technical guidance to stakeholders.
• Oversee the implementation of global documents at regulated market sites and facilitate discussions to achieve consensus.
• Monitor progress of commitments made to regulatory bodies and GxP consultants to ensure timely document availability.
• Drive continuous improvement initiatives to enhance processes, compliance, and the global document collection.
• Perform periodic assessments of global documents based on site feedback, audits, and regulatory inspection observations.

Requirements

• Minimum of 15 years of experience in GxP regulations (including US, EU, Health Canada, TGA, WHO, PIC/S, and ICH).
• Deep expertise in quality systems, specifically manufacturing, compliance, quality assurance, and QMS.
• Exceptional technical writing skills with a strong command of the English language.
• Proven ability to manage multiple assignments simultaneously and work independently.
• Strong competencies in collaboration, decision-making, change management, and leadership.

Preferred Qualifications

• M.Sc., Master of Pharmacy, or Ph.D. in a relevant scientific field.
• Experience working with electronic Document Management Systems (eDMS).

About the Company

Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company dedicated to providing high-quality medicines. We foster an environment where employees can grow, take charge of their professional journeys, and thrive within a supportive, collaborative community.