Quality Manager, Finished Product Quality Operations(12 months fixed term)

Position Summary: 

The QA Managerwill be responsible for the oversight ofoperationalquality activities associated withthe packaging and disposition of commercial and clinical finished products at the Alexion College Park facility(ADMF), ensuring products aremanufacturedin accordance with cGMP, Corporate and Regulatory requirements. This will include the management of a team of Quality professionals in the timely and efficient execution oftheirresponsibilities.Thiskeyrole must ensure effective interaction with other departments and locations regarding GMPdocument review/approval,QA oversight of QMS recordsandinvestigationsandfinished product release. In particular, this will involve partnering with major stakeholders such asPackagingOperations,QC,DS& DPQAteams,Regulatory,EngineeringandPlanning.This role will assist in the optimal deployment of QA resources forfinished productQA operationsandreleaseactivities.

You will be responsible for:

Ensure that all aspects of the manufacture and release of commercial/clinical packaged product are managed in compliance with the Alexion QMS and relevant cGMP regulatory requirements.

Provide quality support for release of clinical and commercial products as outlined in Annex 13 and Annex 16.

Partner with QA bulk drug substance (manufactured at Alexion Dublin) and QC and QP’sinrelation to quality related activities impacting commercial and clinical product release at Alexion Dublin

Partner with External QA (Global) in relation to quality related issues impacting product at CMO sites (where such issues impact in-process and/or packed product for Alexion release).

Partner with in-country Quality personnel and Responsible Person (RP) in relation to quality related issues that may occur post batch release.

Partner with QA Medical devices to support the governance of QMS for medical devices / co-packaged products.

Recruit, retain and develop quality assurance professions to support activities in Quality Operations relating to commercial and clinical batch release, equipment validation for the packaging area and maintaining the Alexion QMS.

Responsible for driving continuous improvement (CI) by initiating quality improvement plans and addressing remediation from CI or inspections.

Creates an environment for ‘right first time’ in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective.

Build collaborative pro-active relationships with other departments/groups to promote and lead timely resolution of issues and efficient follow-up/evaluation for agreed CAPAs.

Ensure that a valid Quality Agreements are in place for sites for batch release which clearly defines cGMP roles and responsibilities between Alexion and other sites as well as product details,specifications,and requirements.

Ensure that customer complaints for the packaging area are managed and assessed through the qualitysystem.

Ensure thatAnnual Product Quality Reportsare compiled and delivered as per relevant product schedule.

Provide Quality input, oversight and guidance to Alexion deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per Alexion SOPs and QMS.

Provide Quality input, oversight and guidance for Change requests and ensure they are progressed in a timely and compliant manner from initiation through to closure according to Alexion SOPs and QMS.

Provide Quality support for Regulatory filings/updates and for maintenance of Site Manufacturing Licences (for commercial and clinical product) asrequired.

Provide support for preparation and management of Health Authority inspections and be a key representative of Alexion for Health Authorities and Regulatory Bodiesinspections.

Provide support for internal and supplier audits as required.

Issuance, control and archival of batch records and manufacturing documentation.

Maintain an up-to -date knowledge of pharmaceutical legislation and industrypractice.

You will need to have:

A minimum of 8 years relevant experience within the biopharma industry or a related field.

A minimum of 3 years in a supervisory/managerial role.

Proven ability to lead, mentor and develop personnel in the requirements and responsibilities associated with maintaining a compliant and efficient Quality Management System

Direct experience of GMP management within a biopharma company, including exposure to FDA, HPRA/EMA,or other authorities of similar standing. 

Demonstrated success in quality management and the resolution of technical challenges require significant appropriateexperience.

Proven ability to direct cost-effective quality programs in a highly regulated and high-risk environment.

Planning and organizing skills to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.

High level technical skills including analytical, auditing, pharmaceuticalmanufacturing,and regulatory inspection management.

Proven ability intechnicalwriting skills.

Excellent interpersonal skills to enable the ability to communicate well, both verbally and written.

The individual in this position is expected to represent Alexion interests,objectives,and policies in a responsible and professional manner.       

We would prefer for you to have:

BS in sciencewith a minimum of 8 to 10 years’ experience in cGMP Quality environment with 3+ years in a managerial role; or equivalent combination of education and experience.