Senior Development Quality Manager - BD&L

Sandoz India; Telangana; Hybrid; INR 4,000,000 - 9,000,000; Full time

Benefits offered by this job

Flexible-hybrid work arrangement

Job summary

Sandoz India is seeking a senior Quality Assurance/BD&L professional with extensive experience in GMP/GDP, QA/QMS, and cross-functional leadership to evaluate regional and global BD&L opportunities. You will drive quality input for governance boards and coordinate with external partners to ensure compliance and robust data integrity.

Lead negotiations on Quality Agreements, oversee CAPA and investigations, and ensure smooth development-to-commercial transition while aligning with regulatory

Qualifications

• 15+ years of relevant experience in QA/BD&L or equivalent.
• Strong knowledge of GMP/GDP, quality systems, and regulatory expectations.
• Proven ability to negotiate quality agreements and lead cross-functional teams.

Responsibilities

• Conduct due diligence for BD&L opportunities, assessing quality, compliance, risks, and probability of success.
• Assess GMP/GDP compliance status and inspection history of potential partners and GMP sites.
• Identify risks and gaps; provide input to decision-making and governance.
• Lead the negotiation and implementation of Quality Agreements (QAA) for early development collaborations.
• Represent Quality as a stakeholder in cross-functional project teams and drive decisions.
• Ensure GDP and GMP alignment; evaluate investigations and CAPA measures.
• Review GMP-related changes and data quality for submissions (CMC, PDRs, stability).
• Support PAI readiness at third-party sites and contribute to dossier approvals.
• Escalate quality risks and communicate status to senior leadership.
• Foster relationships with third-party quality teams to ensure smooth development-to-commercial transition.

Skills

QA/QMS Expertise

Regulatory Knowledge

Negotiation

Stakeholder Management

Leadership

Education

Pharmacy or Life Sciences degree

Tools

QMS Software

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

Essential Requirements

What you’ll bring to the role:

• 15+ years of relevant experience
• Critical Negotiations
• Functional Breadth
• Operations Management and Execution
• Project Management

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

Essential Requirements

What you’ll bring to the role:

• 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!