External R&D; QA Project Leader (PL)

Candidate Profile and Recruitment Guidance The External R&D; QA Project Leader (PL) role is a specialized quality leadership position that supports externally developed pharmaceutical products from development through regulatory submission and commercialization. The role combines technical quality oversight, project leadership, third-party governance and risk management. It is significantly broader than a traditional QA reviewer role and requires individuals who can operate independently while coordinating with multiple internal stakeholders and external partners.

The ideal candidate should be comfortable working in a fast-paced project environment, managing multiple priorities, assessing quality risks and influencing both internal teams and external organizations to ensure projects progress in a compliant and timely manner

Key Capability Areas

Technical and Quality Expertise

Candidates should have a strong QA and GMP foundation with the ability to review technical documentation, assess quality risks, challenge investigations when necessary, and support quality decisions throughout product development. Strong analytical skills are important, as the role requires interpretation of stability data, validation reports, specifications, investigations and other development documentation.

Product Experience

Experience supporting sterile products is highly preferred, particularly ophthalmic products, injectable products, and pre-filled syringes (PFS). Exposure to multiple dosage forms is desirable, as the PL portfolio often includes a broad range of development programs requiring varying levels of quality oversight and technical understanding.

Combination Product and Device Knowledge

Candidates with knowledge of Combination Product regulations (21 CFR Part 4),



drug-device products, design controls and basic medical device regulatory requirements would be strong additions to the team. This area is becoming increasingly important as portfolio complexity continues to grow.

Technology Transfer and Development Experience

Preference should be given to candidates with experience supporting development projects, technology transfers, site transfers, process transfers or other pre-commercial activities where quality oversight must be balanced with project execution and regulatory timelines.

External Partner Management A significant portion of the role involves working with CMOs, CROs, suppliers, testing laboratories and development partners. Candidates should be able to build relationships, hold partners accountable, manage difficult conversations and drive resolution of quality and compliance issues without direct authority.

Project Leadership

Strong organization, prioritization, and project coordination skills are critical. The role requires managing multiple projects simultaneously while coordinating activities across Quality, Regulatory Affairs, Technical Operations, Supply Chain, Business Development, and external organizations

Communication and Influence

Successful PLs are strong communicators who can translate complex quality topics into practical business discussions, influence stakeholders, facilitate cross-functional decisions,



and effectively communicate quality risks to both technical and non-technical audiences.

Competency Areas and Relative Importance

Competency Area

Relative Importance

Technical Quality & GMP Knowledge

25%

Risk Assessment & Decision Making

15%

Project Leadership & Prioritization

12%

External Partner Management

12%

Communication & Influence Skills

10%

Regulatory & Submission Knowledge

10%

Complex Product Experience (Sterile, Biologics, Combination Products)

10%

Digital, Data & AI Literacy

6%

Preferred Candidate Profile The strongest candidates will typically have experience supporting sterile or complex pharmaceutical products, possess strong analytical and quality risk assessment capabilities, and demonstrate the ability to manage external partners and multiple projects simultaneously.

Experience with ophthalmics, injectables, pre-filled syringes, technology transfers, biologics, biosimilars and combination products would be considered a significant advantage. Familiarity with up-to-date quality systems, data analysis and digital tools is also desirable as the organization continues to focus on efficiency and process improvement.

When screening candidates, prioritize individuals who demonstrate a balance of technical expertise, project leadership and stakeholder management. The role is best suited for someone who can independently assess quality risks, navigate complex development projects, influence internal and external stakeholders and provide proactive quality oversight throughout the product development lifecycle. This is not a traditional document-review role, it is a quality leadership position that requires both technical depth and strong collaboration skills.

📌 Project Leader, External R&D QA (Bengaluru)
🏢 Apotex
📍 Bengaluru