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Lonza

Global life sciences contract manufacturer

Quality Transition Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeHyderabad, Telangana, IndiaNo salary listed

About the Job

Requirements

  • At least 10 years of experience within BioPharma, Pharmaceutical Manufacturing, or CDMO environments, including at least 5 years of direct, hands-on operational experience in GMP-regulated Quality functions.
  • Hands-on operational background in at least 2–3 core areas: Quality Assurance, Quality Systems, Qualification and Validation, Data Integrity/Computerized Systems Validation (CSV), GMP Documentation, Deviation/CAPA, Change Control, or Supplier Management.
  • Proven track record of delivering complex process transitions, migrations, or organizational change initiatives; experience within a Global Capability Center (GCC), Global Business Services (GBS), or shared services setup is ideal.
  • Deep knowledge of GMP, GxP, and ICH guidelines, and familiarity with Quality systems such as TrackWise, Veeva Quality/Docs, MasterControl, LIMS, and ComplianceWire.
  • Strong working knowledge of Lean Six Sigma, Agile/Scrum, and continuous improvement methodologies.
  • Strong influencing skills and technical credibility to collaborate effectively with global Quality leaders and Subject Matter Experts (SMEs).
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related technical discipline.

Responsibilities

  • Lead end-to-end migrations of Quality processes from network sites into the Hyderabad Global Capability Center, ensuring full compliance and service continuity.
  • Partner with global site Quality organizations, manufacturing, and Quality Control (QC) teams to execute knowledge transfer and ensure operational readiness across all transition phases.
  • Develop transition strategies, stabilization plans, risk mitigation frameworks, and issue-resolution mechanisms.
  • Drive continuous improvement across migrated processes through standardization, simplification, and process automation in an agile working environment.
  • Guide and challenge global stakeholders on compliance, operational readiness, and transition risks to safeguard quality systems.
  • Mentor and build core technical Quality capability within the local Hyderabad team while fostering cross-functional alignment.
  • Support preparation and execution for regulatory inspections, customer audits, and Quality Management Reviews across transferred activities.

Desired Qualifications

  • Operational Quality Assurance experience is strongly preferred over experience as a pure project manager.
  • Experience delivering transitions in a GCC/GBS or shared services setup is ideal.

About the Company

Lonza

Global life sciences contract manufacturer

Lonza is a global provider of development and manufacturing services for the pharmaceutical, biotechnology, and nutrition sectors. It supports clients from early development through to commercial production, offering integrated processes such as process development, GMP manufacturing, formulation, fill-finish, and quality assurance to bring medicines and nutrition products to market. Lonza’s model is built on end-to-end CDMO capabilities, enabling companies to move from concept to scalable, compliant production with reliable supply chains. What sets Lonza apart is its long history and global footprint, combining decades of experience across chemistry, biology, and nutrition with a broad, end-to-end service network that supports projects from discovery to commercialization. The company aims to be a trusted, long-term partner in life sciences by helping customers efficiently develop and manufacture their products at scale while maintaining strict regulatory and quality standards.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1897

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