Associate Director Quality Assurance (m/f/d) The 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.
Essential Duties and Responsibilities Manage, execute and lead quality activities to ensure compliance with cGMPs, worldwide regulations and company requirements.
Provide assessments to senior management on compliance status and risk posture of supported area(s) and guide alignment of policies and procedures.
Stay informed of current GMP requirements and industry trends, comment on proposed regulations, and communicate impacts.
Ensure departmental SOPs reflect procedures and current regulations, overseeing SOP review and updates.
Manage review and approval of GMP documentation for regulatory filings, clinical supply, development, technology transfer, and equipment qualification.
Coordinate and accompany regulatory agency inspections, facilitate audits, and draft responses to inspection observations.
Advise on GMP compliance aspects of facility design, equipment selection, and departmental SOPs.
Represent Quality in internal or external manufacturing programs, overseeing batch record review, deviation and change management approvals.
Manage all activities within resource constraints while complying with company policies and regulatory requirements.
Develop quality system and policy for Development Quality department as needed.
Represent Development Quality on project teams or committees establishing GMP or quality standards.
Participate in GMP audit/inspection programs at contractors or licensees, evaluate deficiencies, report issues, and resolve audit findings.
Notify appropriate Quality and support area management of compliance issues and performance trends.
Additional Skills and Competencies Experience with fully integrated, automated and recipe-driven operations such as DeltaV, SAP, Manufacturing Execution System.
Experience in drug substance manufacturing.
Participation and leading Health Authority Inspections.
Fluent in English and conversational German.
Required Experience and Skills Experience in pharmaceutical, biotech or regulated industry.
Technical writing experience: investigations, laboratory reports, SOPs, batch records, protocols.
Ability to conduct multiple investigations within established deadlines.
Demonstrated ability to manage multiple projects and initiatives.
Preferred Education, Experience and Skills Master’s Degree in Engineering, Sciences or related field and at least five years in pharmaceutical, biotech or regulated industry.
Experience with formal problem-solving techniques such as Root Cause Analysis or Lean Six Sigma tools.
cGMP experience in sterile, vaccine, bulk or finished goods pharmaceutical environment.
Detailed understanding of Critical Process Parameters, Critical Quality Attributes and equipment qualification principles.
Location and Employment Work location: 6105 Schachen LU
Workload: 100%
Employment start: Immediately
Employment duration: Permanent
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