JOB DESCRIPTION

Abbott Established Pharma Division (EPD) is looking for aDirector Quality Germany Operations (m/f/d)to be based in Neustadt, Germany. Primary Job Function: Responsible for developing and implementing Quality strategy and execution for the Neustadt manfuacturing site and Hannover Development Centre QA Operations.Core Job Responsibilities: Quality and ComplianceResponsible & accountable for Quality & compliance in Neustadt manufacturing site and Hannover Development centreRepresent EPD as the key compliance/quality leader and decision maker responsible for appropriate quality outcomes for the businessImplement the organizational compliance/quality standards and lead the quality vision for the businessImplement a quality system based on sound science and application of the appropriate quality/regulatory/legal requirementsDrives the appropriate compliance/quality direction based on risk management principles, sound science and legal/regulatory requirementsPersonify quality and compliance to EPD Germany external stakeholders, including regulatory agencies & Key customersDemonstrate continuous improvement in the quality performance of the products and the quality system through ongoing evaluationEstablish long and short term strategies that ensure an effective and compliant quality vision is implementedInterpret the regulations and apply the appropriate standards to the quality planning processIntegrate expectations for continuous improvement in quality performance into the quality/business planEnsure the organization understands the quality strategy and how it impacts the quality systemAllocate resources based on quality system priorities and corresponding business needsLeadership and Problem SolvingExecute the EPD Germany strategy in cooperation with other functions while balancing cultural, financial and resource constraintsSet goals for the business that are agreed upon and supported by all functional areas to advance the businessMaintain high expectations of the organization and its people for the effective implementation of the quality strategyRight-size infrastructure to support business growth by improving the integration of new business and divestiture of existing products and businessesCreate a culture of innovation and set an appropriate pace of change in response to evolving business needs and global regulatory environmentApply a global perspective; act with global and local understanding of different cultures/businesses and potential impacts on our products and marketsLeverage strength of quality system as a competitive advantage that drives profitability and customer satisfactionEstablish a learning culture that fosters knowledge transfer and best practice sharing, recognize and value these behaviorsMaintain a focus on customer engagement; proactively identify needs, solicit feedback, and address concerns in a timely mannerRepresent Abbott strategically in the industry through professional associations/advocacySpecifically for Hannover siteProvide QA strategy leadership at the siteLead Quality site activities Manage assigned resourcesensure all site products complianceAssist in resolving problemsProcess queries from the authoritiesPerform Quality Management at the sitePromote Innovation and continuous improvementSpecifically for Neustadt siteTechnical and personnel management of the Quality areas within Neustadt site and overall oversight ofall Quality projectsEnsure the standard quality of the products manufactured at the site in line with applicable quality guidelines & quality systemsAssist in resolving difficulties or decision making in the subordinate areasSupport the team in quality audits by external inspectors, internal audits and processing inquiries fromthe authorities, particularly on inspectionsSupervisory/Management Responsibilities: Direct Reports: 8 - 10 Position Accountability/Scope: Accountable for Quality leadership of EPD Neustadt and Hannover businesses.Accountable for ensuring overall compliance to Regulations, corporate and divisional requirementsAccountable to ensure superior Quality, Compliance and financial performance and uninterrupted supply of products to the customers.Role reports to Patricia Griffiths, DVP QA EPDProfile requirements: Minimum Education: Science/Pharmacy Graduate. Management Degree would be an advantage.Minimum Experience/Training Required: 10 -15 years business/Quality Operations experience of which ten or more are in management.Has advanced technical understanding of pharmaceutical processes, products, and procedures. Must be able to establish strategic direction and lead change.Has strategic organizational development skills Able to develop and implement quality systems. Has strong customer interface skillsHas appropriate level of leadership experience to lead senior Quality management staff. Able to confront and resolve conflict and lead efforts to resolve critical situations. Able to influence decisions of senior management and defining the Quality culture for the business.Uses good judgment to make sound decisions. Hires and develops strong quality professionalsKnowledge of regulations and standards affecting pharmaceutical busines

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