Quality Director – Marketing Company Global Support Lead
Location: Cheshire East, Gaithersburg, Maryland
Job Type: Full time
Quality Director – Marketing Company Global Support Lead
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 Global Support 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 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 Affiliate Quality Strategy, executing regional strategy for Marketing Company 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 affiliate 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 to maintain the local License to Operate.
Design and deliver global Marketing Company Operational Quality processes, working with AZ SMEs to ensure that marketing company requirements are met in processes and systems. Develop and deliver training for quality systems and act at expert for global processes and systems. Drive global standardisation, simplification and improvement of Affiliate Quality business processes, 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..
Deliver an effective governance structure to ensure oversight of quality activities is maintained across MC OQ.
Provide leadership for MC OQ strategy and activities across all markets and commercial SET areas and partner with other Quality groups e.g. PV Quality, Regulatory Quality, GcP Quality to ensure cross GxP processes remain aligned.
Define, develop, deploy and monitor the GMP/GDP policies and standards and execution in MC OQ
Accountable for a MC OQ 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 Compliance reporting to AstraZeneca Operations Leadership and routine Board of Directors Compliance committee related to Affiliate Market Quality performance, including preparation of standard reports.
Represents MC OQ on cross-functional and cross SET teams and steering committees related to MC OQ activities
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 objectives setting for the MC OQ organisation and leads, manages and develops team members in a multi-layered organization. Provide training, supporting and coaching structure for regional Quality Affiliate network roles
Plans, reviews and manages budgets
Responsible for Affiliate GMP&GDP input into divestments/acquisitions/licensing agreements
Member of the Marketing Company operational Quality Leadership Team
Responsible to manage the key global vendor delivering complaints intake.
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 affiliate 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
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. There’s 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. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next…
Are you already imaging yourself joining our team? Good, because we can’t wait to hear from you!
We welcome your CV and covering letter no later than Sunday 29th January
Competitive Salary & Benefits
Open Date: 13/01/2023
Close Date: 29/01/2023
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 requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.