Pharmaceutical Quality Systems Manager

Are you ready to lead and develop our quality systems program? Singapore Operations will play a key role in our ambition to redefine cancer care and deliver life-changing medicines to patients around the world. As the Pharmaceutical Quality Systems Manager, you will be implementing, developing and govern our quality systems in collaboration with senior management and relevant teams in line with AstraZeneca global strategy. Our quality system supports multiple facilities and technologies for end-to-end manufacturing and control within our Campus Site and support our strong new product pipeline.  This role involves leading quality system projects, developing strategic plans, and defining innovative solutions to navigate complex business needs.

You have a key role during on-site as well as paper-based inspections and engages with regulatory agencies and industry/professional organizations to build awareness of trends and initiatives in the quality systems area.

You are proactively seeking opportunities for simplification, change management and digital tool adoption, and liaise with senior management and manage risks and act with integrity to protect our patients and business. With a comprehensive understanding of global processes, you will provide direction and inspire others to learn and improve our pharmaceutical quality management system

Typical Accountabilities

• Lead / oversee an assigned quality systems program at the Singapore Operations Campus or at a regional level.
• Plan, coordinate, and implement quality systems in collaboration with relevant teams. You act as a local business process owner of quality system elements.
• Conduct ongoing monitoring appraisals of quality and compliance systems within area of responsibility.
• Manage the execution of global tasks relating to the quality systems area of accountability and expertise.
• Utilise specialised technical skills within own quality area to achieve quality objectives.
• Analyse, interpret, and communicate data trends and observed deficiencies; provide recommendations to address such developing trends in a proactive manner.
• Develop and deliver modern training programs as required to relevant quality systems teams and other stakeholder
• Support site and quality leadership with planning quality systems programs and identifying continuous improvement opportunities. You have a key role in Quality Management review
• Develop and maintain performance measurements to assess and improve the performance of quality systems and processes within area.
• Proactively look for opportunities to identify and manage change, enable adoption of digital tools, and make simplifications and efficiency savings.
• May liaise directly with local,regional, and global senior management, where necessary, to ensure issues are understood and proposed actions are acceptable.
• Engage with regulatory agencies and/ or industry / professional organisations as applicable to build awareness of trends, digital technologies, and initiatives in quality systems area.

Qualifications and Skills

Essential:

• Bachelor's or Masters degree in science / engineering field such as Pharmacy, Biology, orChemistry; Experience with pharmaceutical manufacturing and quality.
• Extensive experience in business process / quality system management; Experience in continuous improvement, and process streamlining and optimisation; Experience applying Lean principles and leading changing initiatives within a structured framework;
• Experience implementing newer digital tools and technologies related to quality systems management.
• Experience working with cross-functional teams (e.g.,manufacturing, supply and capability, account management, regulatory and market companies,)

·    Desirable: Project management experience preferred.