Project Leader - External R&D Quality Assurance

About the Role and Company

Apotex Inc., a leading Canadian-owned pharmaceutical company with global reach, is seeking a Project Leader for External Research & Development Quality Assurance based in Bengaluru, India. The company boasts over 10,000 employees worldwide, producing more than 300 generic pharmaceuticals with extensive regulatory approvals and an impressive international footprint.

Role Overview

The Project Leader in External R&D QA plays a critical leadership role managing quality oversight for externally developed pharmaceutical products from development through regulatory approval to market launch. It involves comprehensive quality management beyond routine QA tasks, including risk assessment, third-party governance, and cross-functional coordination.

Key Responsibilities

• Provide strong technical quality leadership and oversight throughout product development phases.
• Review technical documents and evaluate quality risks.
• Challenge and support investigations to ensure compliance and quality output.
• Ensure timely progression of projects by influencing both internal stakeholders and external partners.
• Manage relationships and governance of CROs, CMOs, suppliers, testing labs, and development collaborators.
• Coordinate project activities across Quality, Regulatory Affairs, Operations, Supply Chain, and Business Development teams.
• Effectively communicate complex quality and regulatory issues to diverse audiences to facilitate informed decision-making.

Requirements and Qualifications

• B.Sc degree in any specialization.
• Strong foundation in Quality Assurance and GMP principles with experience in reviewing technical and stability data, validation documents, and investigations.
• Preferred experience with sterile pharmaceutical products like ophthalmics, injectables, and pre-filled syringes, and exposure to multiple dosage forms.
• Knowledge of Combination Product regulations (21 CFR Part 4), drug-device products, design controls, and medical device regulations is highly valued.
• Experience in development projects including technology transfers, site and process transfers, balancing quality with regulatory timelines.
• Proven ability to manage external partners and suppliers including accountability and issue resolution without direct authority.
• Strong project management skills to prioritize and manage multiple projects concurrently.
• Excellent communication skills to explain complex quality aspects and influence internal and external stakeholders.
• Familiarity with modern quality systems, data analysis, and digital tools is a plus.

Additional Information

The role is designed for individuals who thrive in fast-paced environments, are proactive in quality risk management across development projects, and possess strong leadership and stakeholder engagement capabilities. This position demands both technical expertise and collaboration to ensure compliance and successful product commercialization.