Senior Quality Lead

Responsibilities:

• Design and Implementation of Quality Strategies:

  •  Establish relationships with business stakeholders and lead the development of molecule/product/process/affiliate-level approaches with appropriate measures (CtQ Factors)

  • Analyze quality data to identify trends and risks, providing insights to business partners

• Delivery of Activities to Assess Quality Status

  • Lead and perform complex audits and quality assessments.

  • Synthesize individual audit issues into systematic conclusions and present findings and associated risks to senior stakeholders, ensuring quality data fulfills regulatory requirements and supports organizational goals

• Demonstration of Implementation to Health Authorities

  • Play a lead role in inspection preparation and management.

  • Provide training to staff and ensure relevant materials are prepared for regulatory review

• Execution of PDQ Goals

  • Lead assigned goals and initiatives and drive the development or revision of PDQ processes

• Networking:

  • Maintain and influence partnerships with senior business stakeholders and PDQ domains

  • Facilitate cross-functional collaboration to ensure quality standards are met globally

• Compliance:

  • Expert knowledge in GxP regulations (FDA, EU, ICH guidance) and internal policies

  • Ensure all activities are conducted in compliance with regulatory and company requirements

Requirements:

• Bachelor’s degree or equivalent in a scientific or quality-related field. Advanced degree preferred

• Significant experience in the pharmaceutical / biotech / medical device industry, including knowledge of the end to end development and operationalisation of products, and the associated GxP regulations and considerations (e.g., GCP,GVP, IVD/MD Regulations) 

• Min. 5 years experience in leading GxP audits and managing complex quality projects 

• In-depth knowledge of drug development processes and global regulatory landscapes 

• Good understanding of Information Systems, e.g., audit management and analysis reporting tools  

• Understanding of business operations and strategies 

• Fluency in written and spoken English; bi or multi-lingual skills are desirable

• Clinical Operations experience or quality function in system validations

• Leadership and Stakeholder Management: Demonstrates exceptional ability to influence, negotiate, and mentor while effectively managing relationships with diverse stakeholders in global settings.

• Analytical and Strategic Thinking: strong data and digital literacy, with the critical thinking ability to synthesize complex or ambiguous information into clear, actionable insights.

• Execution and Independence: Combines strong organizational and project management skills with the capacity to work effectively—both independently and collaboratively—within international, agile matrix organizations.

• Communication: Utilizes advanced presentation and communication skills to drive decision-making and foster cross-functional collaboration.