Ph3Associate Director Quality Assurance (m/f/d) /h3pThe Associate Director, Quality Operations reports to the Associate Director, QA Operation Schachen Biologics and supports clinical quality activities at our Werthenstein site. They will have accountability for Good Manufacturing Practice (GMP) compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance, driving and supporting compliance-based programs and results which include support and leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, Standard Operating Procedure (SOP) management and site procedures. /ph3Essential Duties and Responsibilities /h3ulliManage, execute and lead quality activities to ensure compliance with cGMPs, worldwide regulations and company requirements. /liliProvide assessments to senior management on compliance status and risk posture of supported area(s) and guide alignment of policies and procedures. /liliStay informed of current GMP requirements and industry trends, comment on proposed regulations, and communicate impacts. /liliEnsure departmental SOPs reflect procedures and current regulations, overseeing SOP review and updates. /liliManage review and approval of GMP documentation for regulatory filings, clinical supply, development, technology transfer, and equipment qualification. /liliCoordinate and accompany regulatory agency inspections, facilitate audits, and draft responses to inspection observations. /liliAdvise on GMP compliance aspects of facility design, equipment selection, and departmental SOPs. /liliRepresent Quality in internal or external manufacturing programs, overseeing batch record review, deviation and change management approvals. /liliManage all activities within resource constraints while complying with company policies and regulatory requirements. /liliDevelop quality system and policy for Development Quality department as needed. /liliRepresent Development Quality on project teams or committees establishing GMP or quality standards. /liliParticipate in GMP audit/inspection programs at contractors or licensees, evaluate deficiencies, report issues, and resolve audit findings. /liliNotify appropriate Quality and support area management of compliance issues and performance trends. /li /ulh3Additional Skills and Competencies /h3ulliExperience with fully integrated, automated and recipe-driven operations such as DeltaV, SAP, Manufacturing Execution System. /liliExperience in drug substance manufacturing. /liliParticipation and leading Health Authority Inspections. /liliFluent in English and conversational German. /li /ulh3Required Experience and Skills /h3ulliExperience in pharmaceutical, biotech or regulated industry. /liliTechnical writing experience: investigations, laboratory reports, SOPs, batch records, protocols. /liliAbility to conduct multiple investigations within established deadlines. /liliDemonstrated ability to manage multiple projects and initiatives. /li /ulh3Preferred Education, Experience and Skills /h3ulliMaster’s Degree in Engineering, Sciences or related field and at least five years in pharmaceutical, biotech or regulated industry. /liliExperience with formal problem-solving techniques such as Root Cause Analysis or Lean Six Sigma tools. /lilicGMP experience in sterile, vaccine, bulk or finished goods pharmaceutical environment. /liliDetailed understanding of Critical Process Parameters, Critical Quality Attributes and equipment qualification principles. /li /ulh3Location and Employment /h3ulliWork location: 6105 Schachen LU /liliWorkload: 100% /liliEmployment start: Immediately /liliEmployment duration: Permanent /li /ul /p #J-18808-Ljbffr