Director Marketing Company Operations Quality

**Director Marketing Company Operations Quality**

We currently have an exciting opportunity for a Director Marketing Company Operations Quality, 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 Asia Cluster of Commercial Marketing companies for all AstraZeneca product portfolio in this cluster.

In this role you'll lead a team of quality professionals in the Asia Cluster and participates in development of International AZ Marketing Company Operations Quality (MCOQ) Strategy and executes cluster strategy for MCOQ and Marketing Company (MC) Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP) aligned with AZ’s 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.

**What you'll do**:

- Develop, support and drive excellence in MCOQ activities to maintain the local License to Operate (LTO) within the Cluster
- Primary point of expertise for GMP & GDP contact for the cluster, contributes and supports the development of the applicable processes and procedures and maintains an effective governance structure to ensure oversight of quality activities.
- Provides leadership for GMP & GDP strategy and activities across the cluster as the Quality partner to Commercial SET leaders, Heads and Global Safety.
- Accountable for Asia Quality Management Review process, preparation, execution and escalations to Operations, Commercial and R&D Senior Leadership and SET members, including reporting of quality metrics as appropriate.
- Participates in defining the strategy for the commercial international markets ownership and execution of MCOQ GMP and GDP Quality System and framework in cluster.
- Deploy and monitor the GMP & GDP policies and standards as well as the execution in cluster markets.
- Represents Quality on cross-functional, cross SET teams and steering committees related to markets.
- Drive cluster standardisation, simplification, and improvement of MCOQ 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.
- Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Affiliate GDP’s.
- Accountable for cluster and country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to product release, 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 MCOQ GMP & GDP input into divestments/ acquisitions/ licensing agreements in cluster.
- Partners with cross functional teams to manage QMS processes within the cluster, which includes but not limited to the following:

- Audit & Inspection process
- Complaint management process;
- Deviation/CAPA/Change control management process.
- Document management process.
- Plans, reviews and manages budgets for the cluster MCOQ organisation.
- Third Party Management process
- Issue Management including Recalls, Product Returns, Rejections.
- Quality Risk Management
- GMP & GDP Training Management Process

**Essential Requirements**:

- Degree or equivalent professional qualification in related field
- Experience in quality assurance within a pharmaceutical company and/or distribution environment
- Demonstrated expert level knowledge of GMP & GDP quality management; Experience in GMP & GDP country roles.
- Excellent communication and organization skills with ability to make decisions and influence outcomes related to patient supply and AZ reputation.
- Strong business acumen with Integrity and high ethical standards. Ensures AZ’s LTO for GMP & GDP through development and delivery of effective strategies for GMP & GDP in local marketing companies.
- A good understanding of the technical requirements within Quality and an ability to balance this with industry standards to achieve business goals.
- Excellent people and team management skills
- 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.
- Deve