Our client is a leading healthcare company and is looking to engage with a Quality Assurance head who has strong understanding in Biologic Drug Substance manufacturing process.
Key Responsibilities :
- Accountable for product quality and compliance of operations, per scope.
- Accountable for defining, setting up, executing and continuously improving any related activity, including organisational and human aspects.
- Lead and drive all Operational QA activities for the allocated perimeter, ensuring products manufactured have the expected level of quality.
- Ensure all-time inspection readiness of operations per scope, including preparation to regulatory inspections.
- Foster a right-first-time culture across operations, per scope.
- Implement BBIL Quality management system and governance, propose and implement improvements.
- Drive quality management reviews.
- Ensure consistency, standardisation, efficiency and cost-effectiveness of approaches while always maintaining compliance with regulations and clients’ expectations.
- Define, implement, monitor quality strategy and plan for the allocated perimeter, defining appropriate metrics, relentlessly seeking and implementing best practices or any improvements.
- Ensure proper organisational design to best meet customers’ needs
- Lead, manage, develop and coach the team, fostering the right behaviours and mindset.
- Closely interacts with all business functions to ensure effective contribution to the business ambition
- Actively participate to Quality Leadership Team, lead cross-functional initiatives, proactively support other QLT members where needed.
- Strong understanding of Biologic DS manufacturing processes
- Extensive knowledge of worldwide applicable Quality regulations (US, EU, Brazil etc.)
- Good understanding of Lean principles (Green Belt certification is a “plus”)
- Ability to make clear decisions, appropriately balancing risks versus consequences
- Strong leadership skills, able to get the buy-in of multiple stakeholders
- Ability to work under pressure and cope with multiple priorities
- Ability to drive change throughout an organisation, overcoming resistance and barriers
- Strong communication skills, up to ELT level and key external stakeholders