Quality Director
vor 2 Monaten
**Quality Director - Marketing Company Operational Quality Regional Lead, EuCan**
Switzerland
**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 Director - Marketing Company Operational Quality Regional 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 EuCan Commercial marketing companies for all of the AZ product portfolio in region.
In this role you'll lead a team of quality professionals in Region and participate in the development of Global AZ Marketing Company Operational Quality Strategy, executing regional strategy for Marketing Company Operational Quality and Marketing Company GMP/GDP aligned with AZ’s 2030 bold ambition.
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**:
Develop, support and drive excellence in Marketing Company GMP&GDP Quality activities (for given region) to maintain any local License to Operate.
Primary point of GMP&GDP contact for the Region ensuring an effective governance structure to ensure oversight of quality activities is maintained. Provide expertise for GMP & GDP activities impacting the marketing company organisation in Region.
Provide leadership for GMP & GDP strategy and activities across all markets and commercial SET areas in Region as the Quality partner to Commercial SET leaders, Regional Commercial Heads and Global Safety.
Ownership and execution of Marketing Company GMP and GDP Quality System and framework in Region.
Define, develop, deploy and monitor the GMP&GDP policies and standards and execution in Regional markets. Drive global standardisation, simplification and improvement of Marketing Company Quality business processes.
Accountable for a Regional Marketing Company Quality Management Review process, preparation and execution highlighting issues to Operations, Commercial and R&D Sr. Leadership and SET members.
Actively contributes or leads preparation of Quality Compliance reporting to AstraZeneca Operations Leadership and routine Board of Directors Compliance committee related to Marketing Company Operational Quality performance.
Represents Quality on cross-functional and cross SET teams and steering committees related to Affiliate markets.
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.
Participates in strategy and regional objectives setting for the Marketing Company Operational Quality organisation and leads, manages and develops team members in a multi-layered organization. Provide training, supporting and coaching structure for regional Marketing Company Operational Quality network roles.
Plans, reviews and manages budgets for the Regional Marketing Company Operational Quality organisation.
Accountable for Regional 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 for GMP & GDP matters, GMP and GDP audits and inspection readiness and compliance to gain and maintain AZ licence to operate.
Responsible for Marketing Company GMP&GDP input into divestments/acquisitions/licensing agreements in region.
Member of the Marketing Company Operational Quality 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
Please note: other locations may be considered
At AstraZeneca, we 're dedicated to bein
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