Head of Qualification Support
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What you'll do
- Maintain overall accountability for qualification and validation compliance across equipment, facilities, utilities, and computerized systems for cGMP pharmaceutical manufacturing.
- Direct, enable, and mentor multidisciplinary QA C&Q teams (≥15 FTEs covering Equipment, CSV, Facilities/Utilities, and Enabling Qualification) to achieve consistent high performance.
- Oversee complete commissioning and qualification (C&Q) lifecycles—from initial qualification through routine operations, periodic reviews, and decommissioning.
- Serve as the senior Global QA representative for LCC Quality in global/cross-functional forums to define and harmonize global engineering and quality standards.
- Translate evolving global regulatory guidance (e.g., FDA, Swissmedic, EMA) and inspection outcomes into actionable quality strategies and continuous inspection readiness.
- Evaluate and strengthen data integrity practices, driving standardized processes and continuous improvement initiatives across qualification lifecycles.
- Partner closely with Global & Site Engineering Leads, LCC Quality Leadership, and site QA teams to ensure seamless project execution and alignment.
What they're looking for
- Bachelor’s or Master’s degree in Engineering (Biologics or Chemical) or Biological Sciences.
- 10+ years of relevant experience in a regulated pharmaceutical environment covering QA, manufacturing, engineering, R&D, or regulatory affairs.
- Proven management experience in EMA/FDA-regulated environments with in-depth knowledge of cGMP, ICH, PIC/S, EU, and US regulatory standards.
- Demonstrated experience in QA aspects of facility design, CQV lifecycle management, CSV, equipment validation, change management, and decommissioning.
- Strong people management track record in complex global matrix environments, with proven capability in resource allocation, budget management, and coaching.
- Advanced problem-solving, project management, and risk-based decision-making capabilities.
- Exceptional English communication and interpersonal skills, with the ability to influence cross-functional leaders across global sites.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Quality LCC, Head of Qualification Support
The actual location of this job is in Hyderabad, India. Relocation assistance is available for eligible candidates and their families, if needed.
Lead and shape the qualification, validation, and computerized systems compliance strategies for global cGMP pharmaceutical manufacturing operations from the Lonza Capability Center (LCC) in Hyderabad. In this high-impact executive role, you will lead a dedicated team of QA professionals, drive compliance across international regulatory standards, and elevate global quality engineering practices.
This is an office‑first role. Working together in person supports close, real‑time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).
What you will get:
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
A variety of benefits dependent on role and location.
The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do:
cGMP Compliance Leadership: Maintain overall accountability for qualification and validation compliance across equipment, facilities, utilities, and computerized systems for cGMP pharmaceutical manufacturing.
Team Leadership & Development: Direct, enable, and mentor multidisciplinary QA C&Q teams (≥15 FTEs covering Equipment, CSV, Facilities/Utilities, and Enabling Qualification) to achieve consistent high performance.
End-to-End Lifecycle QA Oversight: Oversee complete commissioning and qualification (C&Q) lifecycles—from initial qualification through routine operations, periodic reviews, and decommissioning.
Global Harmonization & Representation: Serve as the senior Global QA representative for LCC Quality in global/cross-functional forums to define and harmonize global engineering and quality standards.
Regulatory Compliance & Inspection Readiness: Translate evolving global regulatory guidance (e.g., FDA, Swissmedic, EMA) and inspection outcomes into actionable quality strategies and continuous inspection readiness.
Data Integrity & Process Improvement: Evaluate and strengthen data integrity practices, driving standardized processes and continuous improvement initiatives across qualification lifecycles.
Cross-Functional Stakeholder Alignment: Partner closely with Global & Site Engineering Leads, LCC Quality Leadership, and site QA teams to ensure seamless project execution and alignment.
What we are looking for:
Education: Bachelor’s or Master’s degree in Engineering (Biologics or Chemical) or Biological Sciences.
Industry Experience: 10+ years of relevant experience in a regulated pharmaceutical environment covering QA, manufacturing, engineering, R&D, or regulatory affairs.
Regulatory Mastery: Proven management experience in EMA/FDA-regulated environments with in-depth knowledge of cGMP, ICH, PIC/S, EU, and US regulatory standards.
Facility & C&Q Lifecycle Expertise: Demonstrated experience in QA aspects of facility design, CQV lifecycle management, CSV, equipment validation, change management, and decommissioning.
People & Matrix Leadership: Strong people management track record in complex global matrix environments, with proven capability in resource allocation, budget management, and coaching.
Strategic & Analytical Skills: Advanced problem-solving, project management, and risk-based decision-making capabilities.
Communication & Influence: Exceptional English communication and interpersonal skills, with the ability to influence cross-functional leaders across global sites.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Company
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