Senior Manager, Quality Operations (External)

This is what you will do:

The Senior Manager for QualityOperationswillbe responsible forleading andproviding oversight of quality activities associatedwith drug substance/drug producttechnical transfer processes at contract manufacturing organizations (CMOs).The Senior Managerdrivesthe completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of Contract Manufacturing oversight,ensuring compliance with GMP in the supply of commercial and clinical product.Provide Quality service and guidance to various stakeholders.Execute strategies tocontrol, andimprove quality partnering with peers and influencing stakeholders to successfullyembed a strong Quality culture.Identify, evaluate, and drive the remediation of quality risks and quality issues in collaboration with peers in Alexion’s portfolio.

You will be responsibleto:

This position will report to Director of QualityOperations. Duties included but not limited to:

• ManagingQualityAssuranceteamresponsiblefor providing oversight of quality activitiesassociatedwith drug substance/drug product andtech transfermanufacturing processesassociated withcontract manufacturing organizations. Ensuring batches manufactured atcontract organizations are released tocGMP andAlexion requirements.  

• Ensuring compliance of allcontract organisations to both internal Alexion and country specific regulations.

• Buildspartnerships across the business to create a culture thatdemonstratesexcellence in quality,complianceand continuous improvements.

• Provide quality and compliance guidance on all critical and major quality matters managed by Alexion/AZ.

• Trending and analyzing quality aspects of technical transfer activities to measure key performance indicators,identifyareas for continuous process improvements and risk mitigation, and propose and lead team implementation ofappropriate CAPA.

• Provide Quality oversight, input into quality documentse.g.QAGs, customer complaints asrequired.

• Author, review and approval ofQuality Agreements (QAGs),ensuringQuality Agreementsaremaintainedwith allGxPvendors.

• 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.

• Ability to applyleanapproach toidentifyand tap avenues for improving the overall effectiveness of quality processes.

• Support Regulatory Inspections.

• Provide audit support for internal auditingprogramand supplier audits.

• Provide support to Regulatory for Regulatory submissions (IMPD, MAA) 

• Serve as Quality Assurance support and SME fordrug substance/drug product and finished productmanufacturingmaintainingknowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant.

• Acts as the Quality leader with thePDCS,Clinical Supply Quality teams, EM&Oteamsand other stakeholders to ensure on time delivery to the clinic and market.

• Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Product and Finished Product.

• Provides oversighttocontinuous quality system improvements and supports implementing improvements atCMO's incompliance, Preventive Maintenance, Deviation Management and Change Control Programs as theyimpactAlexion.

• Works closely to build relationships with internal and external stakeholders.

• Works closely with internal cross-functional impacted areas, such as EM&O, RegulatoryAffairs,TechnicalServices, Product Development/Clinical Supply to resolve open issuesin a timely mannerresulting from record reviews and deviation events.

• Overseesreviewofcontractordocumentsi.e.Batch records, deviations and change controls to ensure that theycomply withAlexion procedures and meet Alexion standards.

• Approve Alexion specific standard operating procedures and controlled documents issued by contract manufacturingorganisations.

• Support contract manufacturingorganisationaudits, including pre-approval inspections.

• Ensurequality metricspertaining totheprocessquality activitiesaremaintained.

• Reviews and assesses deviations; includes performing risk assessments,participatingin root cause analysis investigations, tracking,follow-upand reporting/trending.

• Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.

• Supports Quality Assurance to guide various projects and technical meetings, as needed.Usesdata and insights for teams to be more responsive and supportmoreeffectivedecision making.

• Responsible for documenting and reporting compliance issues to management.

• Deputize forthe Director,QualityOperationsduring holidays and occasion of absence asrequired.

• Any otherduties asrequired by management.

You will need to have:

• Minimum10-15yearsGMP related experience in biopharmaceutical / pharmaceuticals.

• Significant experienceworking with contract manufacturingorganisationson New Product Introduction and Tech Transfer. 

• Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with ateam orientedapproach.

• Enables effective goal setting, development, coachingand stretch assignments for own teams.

• Ability to provide project leadership and guide successful completion of Quality projects.

• Plans and drivesdelivery with an understanding of cross-functionalinterdependencies.

• Must have thorough knowledge of biopharmaceutical manufacturing,includingtestingand distribution processes and associated global regulatory GMP/GDP requirement

• Experience providing QA oversight across end-to-end technical transfers for biologics—reviewing/approving transfer plans and protocols, ensuring CPPs/CQAs are aligned and compliant. Supporting engineering and PPQ runs including associated deviations, CAPA, and change controls.

• Activelylearnsabout the industry, products,marketand regulatory landscape.Caninterpret implicationson ownarea and guide teams around regulatory documentation,applicationsand review.

• Must have strong task management skills with the ability to prioritize, schedule, and control under tight deadlines.Creates actionable work plans for own areas, accounting for dependencies across different teams.

We wouldprefer foryou to have:

• Experience leading teams

• Extensivedemonstratedpharmaceutical quality experience.

Education/Minimum Years Industry Experience:

• Minimum 10-15yearsGMP related experience in biopharmaceutical / pharmaceuticals.

• Degree in Pharmaceutical Science or similar applicable discipline.

• Consideration will be given to other relevant experience and education in pharmaceutical biotech, or pharmaceutical organizations working in similar roles in Quality and/or Quality Control.