Project manager (generics manufacturing & quality)

Role description

Lead tracking & reporting of end-to-end execution of generics manufacturing and quality programs for commercial manufacturing. Drive cross-functional coordination to ensure timely delivery, regulatory compliance, product quality, supply continuity, and successful commercialization of generic pharmaceutical products.

Key Responsibilities

1. Program Management

Develop and maintain integrated trackers, milestones, timelines, budgets, and governance dashboards. Track progress and ensure on-time delivery of key manufacturing, quality, regulatory, and supply chain deliverables. Lead operations reviews and provide management updates on risks, opportunities, and mitigation plans. Drive accountability across cross-functional teams to achieve project objectives.

2. Quality & Compliance

Partner with Quality teams to ensure compliance with GMP, regulatory requirements, and company quality standards. Oversee project-related deviations, CAPAs, change controls, investigations, and quality risk management activities.

3. Cross-functional Leadership

Collaborate with Manufacturing, QA, QC, Regulatory Affairs, MSAT, Supply Chain, Procurement, R& D, and External Manufacturing teams. Facilitate decision-making and issue resolution among stakeholders. Drive alignment across global and regional teams to meet business priorities.

4. Risk & Stakeholder Management

Identify project risks and develop mitigation strategies. Escalate critical issues proactively and drive timely resolutions. Manage communication with senior leadership and present project progress, challenges, and recommendations.

Qualifications & Experience

Bachelor's or Master's degree in Pharmacy, Biotechnology, Life Sciences, Chemical Engineering, or related discipline. 8–15 years of experience in pharmaceutical manufacturing, quality, technical operations, program management, or related functions. Proven experience managing complex pharmaceutical projects, preferably in generics manufacturing and commercialization. Strong understanding of GMP, regulatory requirements, technology transfer, validation, and quality systems.

Key Competencies

Program & Portfolio Management Manufacturing Operations Quality Systems & Compliance Risk Management Regulatory Knowledge Leadership & Influencing Skills Stakeholder Management Problem Solving & Decision Making Executive Communication