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Country Quality Manager
3 months ago
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.
We are now looking for a Country Quality Manager that will be involved in the design and execution of a common quality management system (QMS) and strategy for GMP and GDP activities across the Commercial Marketing Company (MC) for the AZ product portfolio in country. Additionally, act as a AZ GDP Responsible Person in Czech Republic. You will report into the CEEBA cluster lead and be part of the Global Quality Organisation.
Main tasks and responsibilities:Develop, support and drive excellence in MCOQ GMP&GDP Quality activities.
Primary point of GMP&GDP contact for the country 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 market as the Quality partner to Commercial leader,
- Participates in defining the strategy for the commercial global markets ownership and execution of MCOQGMP and GDP Quality System and framework in country.
- Define, develop, deploy and monitor the GMP/GDP policies and standards and execution in country market. Ensure documentation meets local regulatory standards and maintain oversight of documentation lifecycle management. Ensure MCOQ elements are collected in a business continuity plan.
- Release of medicinal products on the market
- Being responsible for the handling, storage, and transportation of pharmaceutical products. Conducting regular audits and inspections of distribution facilities, processes, and documentation to identify and address any non-compliance issues.
- Accountable for a Country MC Quality Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Sr. Leadership
- Represents Quality on cross-functional teams and steering committees related to MC market.
- Supports global standardisation, simplification and improvement of MCOQ Quality business processes. Supports the MC organisation that delivers against global processes, and aims to continuously improve in competence, compliance standards and innovative delivery of results.
- Plans, reviews and handles budget for the Country MCOQ Quality organisation.
- Accountable for local MCOQ Country specific activities related to, including but not limited to, resolution of Issue Management (post marketing surveillance e.g., Product quality and service and logistic, temperature excursion complaints, product security issues, local recall administrator, influence and decisions on local regulatory agency interactions, as applicable.
- Responsible for MCOQ GMP&GDP input into divestments/acquisitions/licensing agreements/product launches in country.
- Ensures change management process is followed.
- Ensures vendor management, from risk assessment, audits, QAA and qualification to ongoing oversight helping to resolve issues as applicable.
- Ensure quality risk management process is followed and active risk register maintained, as applicable.
- Ensures Customer qualification is performed.
- Responsible for country preparation for MCOQ related Regulatory Agency and AstraZeneca inspections/audits and responses.
- Implements an effective MCOQ self-assessment program.
- Responsible for ensuring QMS compliance and continuous improvement in the country and all issues are handled and closed on time, risks are identified and escalated to Global Quality. Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
- Promotes a Quality Culture in the MC, ensures GDP/GMP/QMS training is performed and that Job descriptions as applicable reflect requirements.
- Provides support to other MC in the CEEBA region.
- Ensures compliance with Safety Health and Environment and all other relevant regulations.
- University degree medical, pharmaceutical, veterinary or life science education.
- Meeting the legal requirements to perform the role of a qualified person under the Medicines Act (GMP/ SDP)
- Experience in Bio/pharmaceutical industry within GDP environment.
- Proven ability to work independently and in project settings to deliver objectives.
- Able to lead trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments.
- Strong communication and influencing skills.
- Project and people management.
- Willingness to travel (up to 40%)
- Driving license cat B
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 imagining yourself joining our team? Good, because we can't wait to hear from you.
Please apply by submitting your CV via our global career website or Linkedin.
Where can you find more?Our Social Media, Follow AstraZeneca on LinkedIn
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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 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.
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