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
