Senior Quality Manager, Distribution

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion AstraZeneca Rare Disease, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you do:

This role is responsible for ensuring that the quality, safety, and traceability of medicinal products are maintained within the supply chain. This role is responsible for ensuring compliance to EU GxP regulations and Alexion procedures as they pertain to distribution.

You will be responsible for:

• Ensure distribution compliance with applicable regulations, the WDA, Manufacturer’s Authorization and Intercompany Agreements as they pertain to GDP and performs GDP duties respectively.
• Provide leadership and technical expertise to the site and business partners in Global Supply Chain and commercial.
• Ensure Alexion, local and global, is kept fully informed of new or emerging GxP/GMP/GDP and regulatory changes in their region.
• In collaboration with the Enterprise Quality organization, weigh and communicate quality and compliance risks as appropriate.
• Ensuring the condition of the licenses are maintained and provide recommendations to Senior Management through Quality Management Review process where APIOL is potentially or actually in breach of the licenses and proposing corrective and preventive actions to promote compliance with the condition of GDP.
• Support Quality Management Review (QMR) in relation to GDP with management.
• Ensure that the quality system is implemented and maintained in compliance with GDP requirements.
• Ensure the management of authorised activities and the accuracy and quality of records.
• Ensure that accurate and Legible records as required by the individual elements of the GDP QMS, are generated and maintained in a secure manner
• Ensure GDP self-inspection are performed in accordance with an approved schedule at defined intervals and that any necessary corrective and preventive actions are implemented
• Lead and provide expertise for the preparation of inspection readiness activities, host inspections including acting as primary contact with inspectors, responses to inspection observations, to monitor progress of follow-up actions, as required.
• Ensure that all personnel involved in the APIOL wholesaling activity are trained in the principles of GDP and Falsified Medicines Directive and continuous training programs are maintained and the implementation of the training programme is effective
• Ensure customer complaints pertaining to GDP are dealt with efficiently and effectively
• Ensure continuity of supply is maintained and ensuring any risk to continuity of supply is escalated.
• Ensure APIOL obligation to the Falsified Medicines Directive is met.
• Ensuring any additional requirements imposed on certain products by national law are adhered to, as foreseen in article 83 of Directive 2001/83/EC.
• Maintain current knowledge of GDP legislation and undergo ongoing training as applicable.
• Partner with local, regional, and global operational groups to foster a proactive approach to compliance.
• Project Management of Key Project Schedules across the network.
• Ensure that any additional requirements imposed on certain products by national law are adhered to.

You will need to have:

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
• Minimum 8 years in international pharmaceutical and/or biotech industry with increased level of responsibility.
• Minimum 5 years of experience in Quality and GDP.
• Thorough knowledge of cGMPs/GDPs and global regulatory requirements
• Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
• Demonstrated success records in improvement processes
• Ability to operate efficiently in a complex matrix organization and international environment
• Strong mature leadership and interpersonal influencing skills
• Ability to represent the company and to negotiate at different levels - contacts both internally and externally including with Health Authorities
• Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels

We would prefer you to have:

• A degree in Pharmacy

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.