Product Quality Leader (all genders)

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

Product Quality Lead (PQL) is responsible for providing quality oversight of Pharma products/franchises throughout the product and design control lifecycle. Develops, approves, monitors, and maintains critical quality standards to proactively minimize product quality and design control risks. Ensures quality management of products and processes lifecycle, leading improvement, developing action plans related Product Quality health, and alignment with current regulatory expectations.  

The individual will partner cross-functionally with various stakeholders e.g.  Supply Network Operations, Manufacturing Sciences & Technology, Global Regulatory Affairs, Site Regulatory Compliance, Healthcare Quality, Global Pharma Manufacturing, as the Quality representative on relevant CMC boards to enable efficient communication and strategic decision making related to the quality of products.

• Provide quality oversight and strategic guidance throughout the CMC lifecycle management of Pharma drug substances and drug products
• Act as a Quality representative in cross-functional forums to provide support and oversight to internal manufacturing and testing facilities for application of PQS,  throughout commercial lifecycle of products
• Serve as a single point of contact for the commercial products, responsible and accountable for overall success against the strategic plan (lifecycle, footprint, risks, business continuity)
• Responsible for commercial product scorecard incl. continuous monitoring, data analysis, reporting, and leveraging the PQS
• Provide quality support for significant changes and deviation and CPA management across  internal manufacturing and testing facilities
• Coordinate deployment and application of controls supporting risk based continued process verification and monitoring of lifecycle product quality
• Ensure significant quality risks are escalated and mitigated in a timely manner
• In partnership with the Digital team(s), identify and implement tools to improve efficiencies of processes.

Who you are:

• Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10 years at minimum
• Working knowledge of relevant EU, China, and Japan regulations, MHRA, FDA, ICH standards/guidelines and experience in supporting successful regulatory inspections,
• Knowledge in design controls, risk management, and quality system requirements
• Working knowledge of control charts and statistics applied to process validation and data trending using statistical programs and software
• Ability to interact effectively with all levels of personnel within the organization
• Proven ability to lead and manage projects / teams of significant scope and complexity, while meeting all deliverables and timelines
• Excellent interpersonal skills using a team oriented approach to project management and problem solving for complex issue resolution in a scientifically sound way
• Outstanding communication skills (both verbal and written)
• Ability to navigate through ambiguity and rapid growth and adapt to change
• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!