Senior QA Manager - Bio Alliance & Launch Governance

Job Description Summary

At Sandoz STO we have committed ourselves to serving 4 billion patients, achieving 1 billion USD in productivity, and generating 1 billion USD in cash by 2029 - all while caring for our people & our planet. This job profile drives integration of Quality Assurance (QA) into Business Development (BD) activities for the Biopharmaceutical portfolio and ensure that potential partnerships, in-licensing opportunities, new product introductions, CMOs/CDMOs, meet the organization’s quality, compliance, and regulatory expectations. The role acts as a strategic QA partner to BD, facilitating risk-based decisions, due diligence assessments, and quality negotiations.
As part of Launch governance, oversee end to end quality readiness for new product introductions, major market expansions within the biopharmaceutical & GLP-1 portfolio and ensure that launch milestones are achieved in compliance with global GxP and internal quality standards.

Job Description

Major Accountabilities:

1. Due Diligence & Quality Risk Assessment

• Perform due diligence for new business opportunities, acquisitions, licensing deals, and new external supply chains.

• Assess manufacturing, testing, and quality systems of potential partners or CMOs/CDMOs.

• Identify quality risks, gaps, and remediation needs; prepare consolidated risk assessment reports.

• Support BD with technical and compliance insights to enable informed decision-making.

•  Provide QA recommendations / mitigations to BD, Legal, and Leadership during deal negotiations

2. Cross-Functional Quality Leadership

• Provide quality leadership during early-stage evaluations, feasibility assessments, and lifecycle planning.

• Support internal QA line functions with timely due diligence summaries and risk-based recommendations.

• Participate in contract negotiations with External Partner focusing on Quality Agreements, compliance clauses, and technical requirements.

• Propose QA budget & resource estimation for Projects.

• Provide QA support during internal or external inspections where needed.

• Collaborate with Project teams – Development, Regulatory, STO/ESO, Manufacturing Science & Technology (MS&T), Supply Chain.

3. QA Launch Governance

• Ensure end‑to‑end QA readiness for assigned new product launches by tracking key deliverables, risks, and submission progress.

• Align on realistic project timelines, monitor milestones, and drive timely risk mitigation across QA functions.

• Provide consolidated QA launch status to governance bodies and support continuous improvement through lessons learned.

• Maintain strong cross‑functional connectivity while ensuring execution remains with site QA teams.

4. General responsibilities

• Support development, upkeep, and continuous improvement of QA standards and best practices for due diligence and launch governance.

• Ensure adherence to regulatory expectations, GxP requirements, and the Sandoz Quality Management System.

• Maintain accurate, high‑quality documentation, records, and governance reporting.

• Drive lean, efficient QA governance processes while maintaining essential compliance.

Qualifications & Experience

Required

• Bachelor/Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.

• 10 + years of experience in Biopharma Industry with at least 5 years in Quality Assurance, with exposure to external manufacturing or business development.

• Strong knowledge of GMP, QMS, and global regulatory frameworks.

Preferred

• Experience with biologics / biosimilars.

• Prior involvement in Business Development, licensing evaluations, or technical negotiations.

• Strong analytical, communication, and project management skills.

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!

Skills Desired

Audit Management, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management, People Management and Leadership, Product Release, Qa (Quality Assurance), Self-Awareness, Technological Expertise