OverviewThe 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.ResponsibilitiesResponsible for the management, execution and leadership of quality activities to ensure compliance with cGMPs, applicable worldwide regulations and the company’s requirements for supported areas.Provide assessments to senior management regarding the compliance status and risk posture of supported area(s) and guidance on alignment of policies and procedures with current regulatory expectations.Remain informed of current GMP requirements and industry trends as described in applicable worldwide regulations and industry standards.Provide comments on proposed regulations and communicate impacts to client areas.Maintain a proficient level of knowledge related to specialized areas of technical expertise.Ensure departmental SOPs reflect departmental procedures and the current regulations.Oversee SOPs in supported areas and ensure periodic updates, as appropriate.Manage the review and approval of GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer and facility of equipment qualification.Ensure compliance with regulatory and company’s requirements.Coordinate the preparations for regulatory agency inspections, as applicable.Accompany regulatory agency officials conducting inspections of facilities or operations in supported areas, including GMP Certification inspections and issue formal reports of inspection activities.Facilitate inspections by corporate auditors or external, non‑government auditors in supported areas.Lead drafting of responses to inspectional observations to satisfy regulatory agency requirements.Advise supported areas on the GMP compliance aspects of the design of facilities, selection of equipment (including computerized systems), preparation of departmental SOPs, quality practices, policies and interpretation of applicable worldwide regulations.Act as Quality representative for internal or external manufacturing programs. Duties include compliance oversight of program‑related activities, batch record review and approval, complex deviation and out‑of‑specification approval, complex change management approval.Efficiently manage all activities within resource constraints while complying with all company policies and regulatory requirements.Develop quality system and policy for Development Quality department as needed.Represent the Development Quality on project teams or committees establishing GMP or quality standards, policies or expectations within the company.Actively participate in GMP audit/inspection program for facilities, systems (including computerized systems) and operations at contractors or licensees engaged in the processing, testing or holding of clinical supplies.Evaluate deficiencies and assess impact on compliance status, report issues as necessary, summarize deficiencies, work with areas to resolve audit findings, and notify appropriate Quality and support area management of compliance issues and performance trends.Required Experience & SkillsExperience in pharmaceutical, biotech or other regulated industry.Technical writing experience (investigations, laboratory reports, SOPs, batch records, or protocols) and ability to conduct multiple investigations within established deadlines.Demonstrated ability to manage multiple projects and initiatives.Direct involvement in Quality Local Lead for Major Companywide Efficiency Project: implementation at Schachen such as automated IT systems (EAM/MES PAS‑X).QMS Redesign Topic Team Member: for facility and Lab QMS to bring Swiss Medic expectations for assessment during implementation of new QMS.Participation in Due Diligence Project to help with integration of new assets.Participation in review of external vendor documents, supporting risk mitigation and decision‑making for potential deals.Upskilling Less Experienced Staff to preserve knowledge and maintain the team’s ability to continue managing complex deviations and change controls.Experience with formal problem‑solving techniques and a hands‑on approach to problem solving, such as Root Cause Analysis or Lean Six Sigma tools.cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment.Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.Preferred Education, Experience & SkillsMaster’s Degree in Engineering, Sciences or related field and at least five years of experience in the pharmaceutical, biotech or another regulated industry.Experience with formal problem‑solving techniques and a hands‑on approach to problem solving, such as Root Cause Analysis or Lean Six Sigma tools.cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment.Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.Core CompetenciesAdaptabilityAudit ManagementCompliance InvestigationsCompliance ProgramsComputer System Validation (CSV)Deviation ManagementGlobal Program DevelopmentGMP ComplianceGood Manufacturing Practices (GMP)Project LeadershipProject Risk AssessmentsQuality Assurance SystemsQuality Management System ImprovementQuality OversightQuality Risk ManagementQuality StandardsQuality Systems ComplianceRegulatory ComplianceRisk Management and MitigationRisk Mitigation StrategiesSAP PP (Production Planning)Strategic ThinkingSystematic Problem SolvingTechnical WritingTraining and Development
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