Quality Senior Professional, Customer Compliance& QAAs

Overview

The QA Expert Compliance ensures that quality agreements (QAAs) and related processes meet regulatory, contractual, and organizational requirements, directly supporting quality negotiations with global customers and alignment between internal stakeholders and customers.

What you'll do

• Support and execute timely negotiations with global customers to define, align, and finalize customer QAAs for Lonza.
• Ensure compliance with GMP and other relevant regulations as well as contractual requirements by maintaining up-to-date quality standards and procedures.
• Verify that customer QAAs meet minimum Lonza QAA requirements.
• Serve as point of contact for internal stakeholders on all QAA-related matters.
• Coordinate with cross-functional teams, including Legal, Quality, Operations and Commercial, to ensure consistency during implementation.
• Prepare and manage QAA updates, including periodic reviews or withdrawal of QAAs.
• Contribute to continuous improvement initiatives within quality compliance processes.
• Analyze current workflows and propose optimizations to increase efficiency and reduce turnaround times.
• Support the implementation of (digital) tools and automation following lean management.
• Provide consistency between Lonza internal processes and commitments in QAAs.
• Collaborate with Global Quality and other sites to drive improvements, harmonize processes, and increase efficiency.
• Provide expert guidance and knowledge sharing across the organization to strengthen compliance awareness.
• Serve as a subject matter expert on compliance-related topics for the business unit and other sites.
• Manage TrackWise records as required.
• Support as a compliance representative in customer audits, inspections, and quality-related discussions as required.

What you'll need

• Superior negotiation and communication of quality-related items.
• Excellent problem solving, decision making and organisational skills.
• Strong analytical capabilities to assess complex regulatory requirements and interpret contractual obligations.
• Strong cross-functional stakeholder management.
• Clear setting of priorities.
• Clear customer focus (internal/external).
• Excellent English skills (spoken and written).

Details

• Location: Hyderabad, India.
• Office-first role: primarily in the office, with flexibility to work remotely for 40% of your time (two days per week).
• Relocation assistance is available for eligible candidates and their families, if needed.