This is what you do:
Manage College Park Distribution Quality Support group.
Provide quality support for Alexion Global Supply Chain in Logistics, Customer Operations, and Commercial Distribution functions in College Park.
Position supports the responsible persons and equivalent country quality managers in distribution related quality management systems support including but not limited to act as deputy/backup RP, act as QA technical contact point with Country Quality Managers at affiliates, own GDP processes and procedures applicable to multiple entities/markets.
You will be responsible for:
- Own GDP processes and procedures applicable to multiple entities/markets.
- Collaborating with RPs and equivalent Country Quality Managers, drive continuous improvement and harmonization/optimization of processes / procedures.
- Develop and enhance training materials related to GDP as needed.
- Define and monitor standard quality KPI and review quality indicators with recommendation for actions for improvement. Attend and develop College Park Distribution related Quality Management Review meetings.
- Collaborate with appropriate RP and Country Quality Managers to provide quality oversight for temperature-controlled validation activities.
- Act as QA technical contact point with Country Quality Managers at affiliates.
- Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the company and with external parties.
- Collaborate with APIOL Responsible Person, review documentation including but not limited to Quality Agreements, change controls, deviations, validation documentation, SOPs and specifications.
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
- Support APIOL Responsible Person to ensure compliance with the general conditions of the Alexion Wholesale Distribution Authorisations and ensure compliance with the requirements of GDP, including but not limited to acting as deputy/backup RP.
- Support work streams relating to market monitoring and investigations relating to the Falsified Medicines Directive.
- Support mergers and acquisitions by performing due diligence inspections, gap analysis and risk assessments on prospective business opportunities.
- Support audits of contractors executed according to Alexion external audit program.
- Project Management of Key Project Schedules across the network.
- Demonstrates core Alexion Values through management style.
- Any other duties as required by management.
You will need to have:
- Minimum 5 years in international pharmaceutical and/or biotech industry
- with increased level of Responsibility.
- Minimum 2 years of experience in QA and GDP.
- Experience in managing contractors.
- 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.
- Management skills for management of a team of Specialists/Sr. Specialists,
- Strong mature leadership and interpersonal influencing skills.
- Ability to represent the company and to negotiate at different levels contacts both internally and externally.
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
We would prefer you to have:
- Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
Date Posted
21-Aug-2024
Closing Date
31-Aug-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.