Job Description

Global Quality Associate Director - Affiliate Quality Cluster Lead

Singapore

Take the responsibility to ensure our pipeline becomes a reality

Take the lead in ensuring the hard work from the rest of the business is realised, as we reliably get every medicine out to patients without challenge. We never give up in diligently ensuring our patients receive quality and safe medicines, responding to a large variety of, often complex, demands.

We currently have an exciting opportunity for a Quality Associate Director - Affiliate Quality Cluster Lead, responsible for overseeing the design, implementation and delivery of a common Quality system and strategy for GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) activities across Cluster of Commercial marketing companies for all of the AZ product portfolio in the Asia Region.

In this role you\'ll lead a team of quality professionals in Region and participates in development of Global AZ Affiliate Quality Strategy and executes cluster strategy for Affiliate Quality and Marketing Company GMP/GDP aligned with AZs 2030 bold ambition strategy for market expansion, product launches and accessibility.

Accountable for assurance of compliance with worldwide standards for all local GMP & GDP activities, connecting marketing company offices and the broader Operations Quality and R&D organisation operating under One AZ QMS.

What you\'ll do:

For given cluster, develop, support and drive excellence in Affiliate GMP&GDP Quality activities to maintain the local License to Operate.

Primary point of GMP&GDP contact for the Cluster and maintains an effective governance structure to ensure oversight of quality activities.

Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities across all markets and commercial SET areas in Cluster as the Quality partner to Commercial SET leaders, Regional Commercial Heads and Global Safety

Participates in defining the strategy for the commercial global markets ownership and execution of Affiliate GMP and GDP Quality System and framework in Region

Define, develop, deploy, and monitor the GMP/GDP policies and standards and execution in markets in cluster

Accountable for a Cluster Affiliate Quality Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Sr. Leadership and SET members

Contributes to preparation of Compliance reporting to AstraZeneca Operations Leadership and routine Board of Directors Compliance committee related to Affiliate Market Quality performance

Represents Quality on cross-functional and cross SET teams and steering committees related to Affiliate markets

Drive global standardisation, simplification and improvement of Affiliate Quality business processes. Develops and sustains a high-quality organisation that delivers against global processes, and aims to continuously improve in competence, compliance standards and innovative delivery of results.

Provide training, supporting and coaching structure for cluster Quality Affiliate network roles

Participates in strategy and cluster objectives setting for the Affiliate Quality organisation and leads, manages and develops team members in a multi-layered organization

Is the primary point of expertise for GMP & GDP activities impacting the affiliate organisation in Cluster

Plans, reviews and manages budgets for the Cluster Affiliate Quality organisation

Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Affiliate GxPs.

Accountable for Cluster and Country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batched, resolution of Issue Management, recalls, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ licence to operate.

Responsible for Affiliate GMP&GDP input into divestments/acquisitions/licensing agreements in region

Member of the Affiliate Quality Regional Leadership Team

Essential Skills:

• Demonstrated expert level knowledge of GMP/GDP quality management. Demonstrated ability to deliver a GMP/GDP quality strategy across multiple countries Collaborative/matrix management skills
• Experience in GMP/GDP country roles
• Ability to deliver near and longer term marketing company GMP/GDP strategy across regions and countries in AZ Commercial network and partners.
• Excellent communication and organization skills with ability to make decisions and influence outcomes related to patient supply and AZ reputation.
• Strong intuition for business with Integrity and high ethical standards.
• A broad understanding of the technical requirements within Quality and an ability to balance this with industry standards to achieve business goals
• Demonstrated ability to deliver through others
• Ensures local teams have the skills and capabilities to meet company and regulatory standards for their GMP/GDP activities.

• Reviews GMP/GDP specific quality management data such as risk and issues data for trends and compliance with QMS standards
• Ensures effective and timely complaint management by MCs
• Develops the GMP/GDP training and capability plan for MCs to ensure local GMP/GDP
• Ensures Regional Teams have the skills required to meet regulations and maintain an inspection ready state and maintain the License to Operate.
• Maintains the MC Distribution Activities and the MC Manufacturing Activities training roles.

Please note: other locations may be considered

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. Were on an exciting journey to pioneer the future of healthcare.

So, whats next

Are you already imaging yourself joining our team? Good, because we cant wait to hear from you!

We welcome your CV and covering letter no later than Wednesday 7th June 2023.

Competitive Salary & Benefits

Open Date: 24th May 2023

Close Date: 7th June 2023

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Date Posted 24-May-2023

Closing Date 23-May-2023

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca