Daicel Chiral Technologies - Senior Manager - Quality Assurance (14-16 yrs)

About the Role:

As a Senior Manager - Quality Assurance, you will lead the QA team, ensuring compliance with regulatory standards and driving continuous improvement.

You will oversee quality systems, regulatory inspections, and training programs while collaborating with cross-functional teams to maintain high-quality standards in pharmaceutical and biopharma analytical services.

Key Responsibilities:

- Lead and manage the QA team's daily planning and execution

- Oversee quality objectives, ensuring effective implementation

- Review and approve all quality-related documents, SOPs, and compliance reports

- Handle QMS processes, including Change Controls, Incidents, Deviations, OOS, OOT, and audit observations

- Participate in critical investigations to identify root causes

- Ensure training programs on cGMP, GLP, GDP, and regulatory requirements are effectively implemented

- Collaborate with internal teams to resolve quality-related issues

- Manage customer and vendor quality agreements

- Report QMS performance to top management

- Identify areas for QA improvement and develop sustainable solutions

Qualifications:

- M.Sc.(Chemistry) / M.Pharmacy

- 14 to 16 years of QA experience in Pharma/Biopharma Analytical Services

- Proven expertise in handling US-FDA inspections