Job
Description
As the Head Quality - Emerging Market at the company, you will be responsible for holding overall QA & QC GMP responsibility for the site in the Emerging Markets. Your role will involve providing strong leadership to ensure QA, QC, and all other QMS activities are carried out effectively. You will be accountable for assuring the supply of high-quality, GMP compliant drug products to Sun Pharma customers and markets, leading quality goals, objectives, and maintaining compliance at all sites. - Ensure all Finished products and APIs intended for use in the market meet cGMP requirements, regulatory commitments, Sun policies & SOPs. - Track, trend, maintain, and report all Quality and business metrics to monitor and action all QA & QC compliance activities. - Prevent Quality or regulatory non-compliance issues that could negatively impact the quality, financial performance, and reputation of the company. - Rationalize and manage Quality processes, operations, and systems, and perform gap analysis for continuous improvements. - Plan and monitor resource allocation, budget, and organizational development. - Lead continuous Quality & Compliance improvement initiatives, standardizations, and efficiency gains. - Coach and develop direct and indirect reports, provide training and development opportunities. - Lead Global Projects in collaboration with GQLT and act as a key resource for global regulations. - Maintain a network of subject matter experts in critical GMP Operations and support global strategy development. **Qualifications Required:** - Educational Requirements: Masters Degree in Chemistry, Pharmacy, or relevant life scientific field is required. Ph.D. in a related discipline would be an asset. - Industrial Experience & Knowledge: Minimum 25+ years of experience in pharmaceutical quality management leadership role, strong knowledge of GMPs, and global regulatory requirements. Excellent leadership, communication, and negotiation skills are essential. Ability to work effectively in an international multicultural matrix organization is preferred. As the Head Quality - Emerging Market at the company, you will be responsible for holding overall QA & QC GMP responsibility for the site in the Emerging Markets. Your role will involve providing strong leadership to ensure QA, QC, and all other QMS activities are carried out effectively. You will be accountable for assuring the supply of high-quality, GMP compliant drug products to Sun Pharma customers and markets, leading quality goals, objectives, and maintaining compliance at all sites. - Ensure all Finished products and APIs intended for use in the market meet cGMP requirements, regulatory commitments, Sun policies & SOPs. - Track, trend, maintain, and report all Quality and business metrics to monitor and action all QA & QC compliance activities. - Prevent Quality or regulatory non-compliance issues that could negatively impact the quality, financial performance, and reputation of the company. - Rationalize and manage Quality processes, operations, and systems, and perform gap analysis for continuous improvements. - Plan and monitor resource allocation, budget, and organizational development. - Lead continuous Quality & Compliance improvement initiatives, standardizations, and efficiency gains. - Coach and develop direct and indirect reports, provide training and development opportunities. - Lead Global Projects in collaboration with GQLT and act as a key resource for global regulations. - Maintain a network of subject matter experts in critical GMP Operations and support global strategy development. **Qualifications Required:** - Educational Requirements: Masters Degree in Chemistry, Pharmacy, or relevant life scientific field is required. Ph.D. in a related discipline would be an asset. - Industrial Experience & Knowledge: Minimum 25+ years of experience in pharmaceutical quality management leadership role, strong knowledge of GMPs, and global regulatory requirements. Excellent leadership, communication, and negotiation skills are essential. Ability to work effectively in an international multicultural matrix organization is preferred.
