Quality Assurance Manager (12 months fixed term)

Position Summary:

• The QA Manager for the Bulk Drug Substance (BDS) facility at ADMF willbe responsible forproviding oversight of quality activities associated with the manufacture and disposition of bulk drug substances at ADMF.

• The QA Manageris responsible forensuring that manufacturing, testing, labelling, and storage of Bulk Drug Substancescomply withall applicable GMP regulations andthe productauthorisations. This responsibility includes the oversight of BDS Manufacture to ensure that quality and compliance requirements are followed in line with business needs.

• The QA Manager executes the site QA activities at Alexionin order toprotect the safety,qualityand efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. 

• This management role will ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases.In particular, thiswill involve partnering with major stakeholders such as Operations, Technical Services, QC, QPs, Facilities,Engineeringand Supply Chain tooptimizepatient supply.

• This role will safeguard the efficient and effective running of QA Shift duties ensuringtimelyPBR review, Real-time review,Changoveractivities and day-to-day trouble shooting in the BDS facility.

Principal Responsibilities:

• Leading and mentoring a QA team thatprovidequality and cGMP input and oversight for all New Product Introduction and commercial manufacturing activities for the BDS facility.

• Maintaining and improving an efficient process of Master Batch Record and Electronic Batch Record review and approvalin accordance withAlexion’s internal procedures and GMP principles.

• Ensuring BDS support documentation (logbooks,protocolsetc.) ismaintainedand completed to GMP principles.

• Act as Quality point person, providing guidance and feedback on operational quality assurance issues to stakeholders.

• Ensures schedules for review and approval of GMP documents aremaintainedto meet the needs of Commercial Operations groups

• Participating in quality risk assessments andprovidequality oversight to ensure quality risk assessments are effectivelymaintained/ controlled.

• Overseeing inspection readiness activities and health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring progress of inspection follow up actions.

• Providing oversight of quality management system activities including Preventive Maintenance, DeviationManagementand the Change Control Programs

• Providing quality oversight of calibration and preventativemaintenancecriticality assessments.

• Authoring reviewing and approving Quality Related Procedures asrequired.

• Supporting the Supplier Management Program.

• Developing and reporting quality.

• Deputizing for other BDS Quality leadership team members during holidays and occasion of absence asrequired.

Qualifications:

• Third level qualificatione.g.BSc in science/pharmacy with a minimum of 5 years’ experience incGMPQuality environment; or equivalent combination of education and experience.

• Strong knowledge of cGMP requirements for pharmaceutical manufacturingrequired.

• Previousdirect involvement in FDA, HPRA/EMA or other authority inspections isrequired.

• Excellent accuracy and attention to detail in Operational Quality matters.

• Good knowledge of relevant computersystemse.g.Trackwise, SAP, MCS,MESor similar.

• Planning andorganisationalskills arerequiredto plan,executeand track commitmentsofQuality Assurance and to adjust to changing priorities.

• Detailed technical knowledge of biopharmaceutical manufacturing, Drug SubstanceAnalysisand preparing for regulatory inspections is expected.

• Strong technical writing skills arerequiredin addition to excellence in verbal and written communication skills.

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

• Resilience and adaptability to changing priorities.

We would prefer for you to have:

• Supervisory/ Team Lead experience would be a distinct advantage.

• QP Qualified is an advantage but not essential.