Some opportunities happen only once in a lifetime – like a job where you have the chanceto change lives. At Alexion, 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 will do:
Position is responsible for the quality oversight of the distribution of Alexion products world-wide. Position ensures product shipments are managed in compliance with GDP requirements and applicable Alexion procedures. Position supports Alexion Logistics, Customer Operations and Commercial Distribution functions globally and is primary QA technical contact point with external distribution partners (distributors, carriers, suppliers).
You will be responsible for:
- Responsible for QA oversight of cold chain activities in all markets in accordance with local and international requirements and Alexion planning schedules; insure products shipments are managed in accordance with GDP’s requirements.
- Assess cold chain shipments and provides corresponding quality decision on product.
- Act as primary QA technical contact point with distribution partners. Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the company and with external parties.
- Review documentation including change controls, deviations, validation documentation, SOPs and specifications.
- Ensure Quality Agreement with Alexion’s distribution contractors and carriers are established and maintained. Support the conduct of Quality and Operations review meeting with Distribution contractors.
- Contribute to define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to GDP’s contractors.
- Support the preparation of Health Authorities inspections and provide support for regulatory submissions.
You will need to have:
- 5+ years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment
- Thorough knowledge of Cold Chain activities
- Thorough knowledge of cGMPs/GDPs and global regulatory requirements
- International exposure in positions interacting with and influencing site operations.
- Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
- Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment.
- Good verbal and written communication skills with well-structured communication and ability to present to various audience levels.
We would prefer for you to have:
Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering.
Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Furtherinformation about Alexion can be .
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, clickhere.