Some opportunities happen only once in a lifetime – like a job where you have the chance to 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:
- The Country Quality GxP Compliance Specialist Germany works under the responsibility of the Director Regulatory Affairs and Quality Germany and will be supporting the implementation and execution of the Corporate Quality System at the German affiliate within Alexion.
- The candidate will be supporting the Responsible Person, RP for Alexion Germany and will have experience in GxP’s and quality systems.
- If necessary, the candidate may also be supporting the Regulatory Affairs function within the team
You will be responsible for:
- Support the local roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards
- Support the implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GDP audits
- Support the assessment of compliance on a regular basis
- Participate in the customer (re)-qualification process
- Assist the self-inspection program and independent audits, performed at regular intervals
- Handling of quality records, including but not limited to:
- Deviation Management
- Corrective Action Preventative Action (CAPA)
- Complaint Management
- Change Control Management
- Documentation Management
- Training Management
- Recall Management
- Self-Inspection Management
- Quality Risk Management
- Quality Management Review
- Vendor Management
- If necessary, support the Regulatory Affairs function with regards to regulatory compliance of drugs commercialized by Alexion Pharma in Germany with applicable regulations and Alexion´s quality management system (QMS)
You will need to have:
- 1-2 years of Quality Assurance experience in pharmaceutical/ biotech industry
- Knowledge of applicable local and global regulatory requirements required for GxP compliance
- Knowledge in a broad range of pharmaceutical activities and Quality Systems
- Very good communication and interpersonal skills
- Ability to work globally in a matrix environment
- Excellent German and English language skills
We would prefer you to have:
- Bachelor’s degree in natural science or PTA education
- 1-2 years of experience in the regulatory environment
Alexion is 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. Further information about Alexion can be found at: www.alexion.com.
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 lack thereof, sex, sexual orientation, 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 an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. 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, click here.