Senior Development Quality Manager - BD&L
Sandoz · Telangana (Sandoz)
Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!Provide quality assurance and compliance oversight to development and research functions. Drive the oversight of quality management systems and initiatives within the global, regional, and country organization, ensuring compliance with applicable health authority regulatory requirements (e.g., GCP, GLP, GMP, PV, IP) and Sandoz procedures and quality standards. Role model good quality behaviors while promoting a culture of quality (e.g., right first time, etc.) to positively impact the non-quality stakeholders (e.g., , SGD/Development). Develop, drive and/or support Quality plan initiatives in order to achieve organizational strategy, mission and vision.
Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Conduct comprehensive due diligence for regional & global early-stage Business Development & Licensing (BD&L) opportunities, assessing quality, compliance, risks, and probability of success.
- Assess GMP/GDP compliance status, quality systems, and inspection history of potential partners and GMP sites
- Identify critical risks, compliance gaps, and “showstoppers” impacting deal feasibility and probability of success (POS). Provide quality input to BD&L decision-making and governance boards
- Lead the negotiation and implementation of Quality Agreements (QAA) for early development collaborations, ensuring alignment with regulatory expectations and company standards.
- Represent Quality as a key stakeholder in cross-functional internal and external project teams, driving decision-making and ensuring quality considerations are embedded throughout development.
- Ensure alignment between Good Development Practices (GDP) and GMP requirements. Evaluate deviations, OOS (Out of Specification), and OOT (Out of Trend) investigations to ensure robust root cause analysis and implementation of effective CAPA measures.
- Review and approve GMP-relevant change controls impacting regulatory dossiers, ensuring compliance and data integrity. Assess quality aspects of submission-relevant data (e.g., CMC documentation, development reports) including:
- Analytical methods and method validation
- Master Batch Records (MBRs)
- Stability data
- Product Development Reports (PDRs)
- Specifications and justification of specifications, ensuring scientific rigor, consistency, and adherence to compendial and quality standards.
- Support pre-approval inspection (PAI) readiness at third-party manufacturing sites and contribute to successful regulatory inspections and dossier approvals.
- Escalate project quality risks and communicate status updates to senior leadership, enabling informed strategic decisions.
- Build and maintain strong working relationships with quality teams at third-party organizations to foster collaboration and facilitate smooth transition from development to commercial operations. Act as trusted advisor to BD&L and partner organizations on quality topics. Facilitate alignment across cultures, organizations, and quality systems
What you’ll bring to the role:
Essential Requirements:
- Industry/ Business Exposure
- 15+ years of relevant experience
- Critical Negotiations
- Functional Breadth
- Operations Management and Execution
- Collaborating across boundaries
- Project Management
- People Leadership
Skills:
- Agility
- Audit Management
- Auditing
- Business Partnering
- Continuous Learning
- Drug Development
- Health Authorities
- Influencing Skills
- Leadership
- Organizational Savvy
- People Management
- Quality Assurance (QA)
- Quality Management Systems (QMS)
- Risk Management
- Root Cause Analysis (RCA)
- Self-Awareness
- Stakeholder Management
- Technological Expertise
- Vendor Management
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
Join us!
Skills Desired
Agility, Auditing, Audit Management, Business Partnering, Continued Learning, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, ISO 9001, Leadership, Organizational Savvy, People Management, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Stakeholder Management, Technological Expertise, Vendor Management