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:
The Computer Systems Validation (CSV) Lead has responsibility for the CSV strategy at ADMF. The position has oversight on the introduction and maintenance of all computer systems onsite utilized to support GMP manufacturing.
Reporting to the Validation lead, within the Engineering function, this role is responsible for management on all computer system validation testing documentation, development and execution of protocols, and strategic planning for compliant computerized operations in a GMP environment.
The position will be responsible for ensuring the data produced and stored by computerized systems are tested in full compliance with all applicable regulations during initial qualification. The position will manage the ongoing periodic review process for computerized systems and investigate any potential gaps identified.
The role will support the establishment of standard work practices and testing for the qualification and ongoing maintenance of computerized systems at ADMF. Where computerized system limitations are identified, this individual will liase with the applicable manufacturing teams to drive the implementation of procedural solutions.
The CSV Lead will support investigations, resolve potential data integrity issues, and implement process improvements to mitigate any risks to data management/storage.
The role will include engaging in early stage of computerized system projects, providing input into design, vendor management and design reviews ensuring validation requirements are met in line with regulatory expectations.
You will be responsible for:
- Act as Validation SME on all computer systems onsite utilized to support GMP manufacturing.
- Manage and implement process improvements to the existing CSV strategy at ADMF.
- Support regulatory inspections for both new and existing computerized systems.
- Develop standard testing plans to ensure the integrity of all data produced by various computerized systems.
- Assure that all validation test procedures are in line with current technology, Alexion, and regulatory requirements.
- Provide validation support in introducing equipment and process improvements to existing equipment.
- Lead the CSV team with key emphasis on:
- Creation and Execution of Validation Documents
- Preparation of Summary Reports
- Scheduling Activities
- Ownership and Closure of open issues (Deviations etc.)
- Identifying compliance gaps with existing computerized systems and proactively working towards their remediation.
- Keeps up to date on regulations and global quality documents updates with respect to CSV and evaluate the impact on site activities.
- Maintains a constant state of inspection readiness within area of responsibility and contributes to this process across the wider Validation department.
- Maintain the Site Computer System Inventory and manage the periodic review process.
- Leading Risk assessments, root cause analysis and investigations as applicable.
- Be a champion for safe working practices and safety initiatives within their functional area.
You will need to have:
- Minimum 7 years of experience in a relevant technical or managerial role.
- Thorough knowledge of cGMPs, GLPs, GDPs, PICS, Data Management and Data Integrity and Computer Systems Validation requirements.
- Strong awareness and understanding of the biopharma business, especially with regards to quality and regulatory requirements.
- Experience of Testing GAMP Category 3, 4 & 5 systems, and an understanding of current industry requirements of Annex 11, GAMP, 21 CFR Part 11.
- Excellent technical abilities with a solid base in engineering.
- Ability to keep work pace and meet deadlines. Good organisation and planning skills.
- Ability to manage the CSV team workload and schedule activities as applicable
- Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
- Ability to work independently and remotely with minimum direct supervision.
- Strong Critical thinking skills.
- Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
- Must be goal-oriented and able to prioritize and manage tasks.
We would prefer for you to have:
- Technical Degree in Engineering/Life Sciences/Computer Science or greater preferred.
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.