Quality Manager

Alexion Pharmaceuticals
Employment Type
Not disclosed
Alexion Pharmaceuticals logo

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.

Position Summary

The Quality Manager will establish, manage and support continuous improvement activities of quality systems and processes to ensure compliance, achievement of site goals / objectives and Inspection readiness. The Quality Manager will implement site level Quality Improvement initiatives in Computerised Systems Utilisation, Data Management, Risk Management, Human Error Assessment and documentation processes, in addition to being able to react to Quality and Compliance Trends that are identified in QMR. This role will reduce and/or avoid significant Quality and Compliance site level risks in ADMFs manufacturing, testing and release processes.

The position will oversee all Data Management systems required to support commercial GMP manufacturing and testing activities at the Alexion facility in College Park Dublin. The position is responsible for driving sitewide initiatives and improvements in data management and data integrity at the site and will oversee the optimised implementation of all computerised systems for the benefit of QA interface with those systems. This position is responsible for monitoring and supporting the data management and performance review at the College Park Site to all applicable GMP standards. The Quality Manager will lead investigations, resolve potential quality issues, recommend and implement changes as necessary in order to mitigate risks associated with data integrity and data management.

Principal Responsibilities

  • Provide strong Quality and Compliance Leadership to the site.
  • Recognise and communicate on potential quality and compliance risks to the leadership team and drive remediation plan as appropriate.
  • Contribute to the design and implementation of best practice quality improvement programs.
  • Responsible for implementing the Data Integrity Strategy ensuring objectives are effectively achieved, consistent with Alexion’s requirements to ensure compliance.
  • Lead Data Integrity (DI) activities at ADMF for both computerised and non computerised systems. Lead the site in the compliance requirements of Data Management and Data Integrity.
  • Maintain DI policy and current controlled documents on DI/CSV in line with current regulations and industry standards on data integrity principles and CSV requirements
  • Ensure all associated systems are qualified in compliance with industry standards and regulatory expectations.
  • Provide Quality direction, expertise and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records.
  • Reviewing and assessing compliance of computerised systems including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up, and reporting/trending.
  • Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
  • Prepare and present periodic management updates on Data Management and Computerised Systems including how these systems improve performance at the site.
  • Interact professionally with company management, internal departments and other sites to

effectively implement and maintain Quality Systems.

  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Improve electronic capabilities in the area of Material Management, Vendor Management and QA disposition of materials.
  • Develops and owns project plan, establishing a road map with clear dates and clear deliverables as required.
  • Provides regular project updates to project team, relevant departments, stakeholders, project champions and senior leadership as needed.
  • Drives cross functional quality improvement programs.

Qualifications & Experience

  • Academic degree in Engineering or Natural/Applied Sciences (e.g. Chemistry, Pharmacy, Biology, Biotechnology, Engineering).
  • Minimum of 8 years’ experience in cGMP Quality environment and 3 years in a relevant QA or Technical managerial role.
  • Thorough knowledge of cGMPs, GLPs, GDPs, Data Management and Data Integrity and Computer Systems Validation requirements.
  • Strong technical experience
  • Ability to interpret and apply GLPs, GDP’s and GMPs for regulated systems validation.
  • Strong awareness and understanding of the biopharma business, especially with regards to quality and regulatory requirements.
  • Demonstrated success in process improvement and sustaining change.
  • Ability to operate efficiently in a complex matrix organization and international environment
  • Proficient in Computerised Systems utilised in Biopharma SAP, LIMS, MES, Veeva Vault and Trackwise.
  • High Level understanding on Manufacturing Automation Applications (e. PI) and Laboratory Instruments.

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.