31 Jul
|
BIOCON BIOLOGICS
|
Bengaluru
31 Jul
BIOCON BIOLOGICS
Bengaluru
Job Description Role description
n 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.
n Key Responsibilities
n 1. Program Management
n n Develop and maintain integrated trackers, milestones, timelines, budgets, and governance dashboards.
n Track progress and ensure on-time delivery of key manufacturing, quality, regulatory, and supply chain deliverables.
n Lead operations reviews and provide management updates on risks, opportunities, and mitigation plans.
n Drive accountability across cross-functional teams to achieve project objectives.
n n 2. Quality & Compliance
n n Partner with Quality teams to ensure compliance with GMP, regulatory requirements, and company quality standards.
n Oversee project-related deviations, CAPAs, change controls, investigations, and quality risk management activities.
n n 3. Cross-functional Leadership
n n Collaborate with Manufacturing, QA, QC, Regulatory Affairs, MSAT, Supply Chain, Procurement, R&D;, and External Manufacturing teams.
n Facilitate decision-making and issue resolution among stakeholders.
n Drive alignment across global and regional teams to meet business priorities.
n n 4. Risk & Stakeholder Management
n n Identify project risks and develop mitigation strategies.
n Escalate critical issues proactively and drive timely resolutions.
n Manage communication with senior leadership and present project progress, challenges, and recommendations.
n n Qualifications & Experience
n n Bachelor's or Master's degree in Pharmacy, Biotechnology, Life Sciences, Chemical Engineering, or related discipline.
n 8–15 years of experience in pharmaceutical manufacturing, quality, technical operations, program management, or related functions.
n Proven experience managing complex pharmaceutical projects, preferably in generics manufacturing and commercialization.
n Solid understanding of GMP, regulatory requirements, technology transfer, validation, and quality systems.
n n Key Competencies
n n Program & Portfolio Management
n Manufacturing Operations
n Quality Systems & Compliance
n Risk Management
n Regulatory Knowledge
n Leadership & Influencing Skills
n Stakeholder Management
n Problem Solving & Decision Making
n Executive Communication
n
📌 Project Manager (Generics Manufacturing & Quality) (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru