Neustadt am Rübenberge, DEU
4 days ago
Director Quality Germany Operations
Abbott Established Pharma Division (EPD) is looking for a **Director 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 Compliance** + Responsible & accountable for Quality & compliance in Neustadt manufacturing site and Hannover Development centre + Represent EPD as the key compliance/quality leader and decision maker responsible for appropriate quality outcomes for the business + Implement the organizational compliance/quality standards and lead the quality vision for the business + Implement a quality system based on sound science and application of the appropriate quality/regulatory/legal requirements + Drives the appropriate compliance/quality direction based on risk management principles, sound science and legal/regulatory requirements + Personify quality and compliance to EPD Germany external stakeholders, including regulatory agencies & Key customers + Demonstrate continuous improvement in the quality performance of the products and the quality system through ongoing evaluation + Establish long and short term strategies that ensure an effective and compliant quality vision is implemented + Interpret the regulations and apply the appropriate standards to the quality planning process + Integrate expectations for continuous improvement in quality performance into the quality/business plan + Ensure the organization understands the quality strategy and how it impacts the quality system + Allocate resources based on quality system priorities and corresponding business needs **Leadership and Problem Solving** + Execute the EPD Germany strategy in cooperation with other functions while balancing cultural, financial and resource constraints + Set goals for the business that are agreed upon and supported by all functional areas to advance the business + Maintain high expectations of the organization and its people for the effective implementation of the quality strategy + Right-size infrastructure to support business growth by improving the integration of new business and divestiture of existing products and businesses + Create a culture of innovation and set an appropriate pace of change in response to evolving business needs and global regulatory environment + Apply a global perspective; act with global and local understanding of different cultures/businesses and potential impacts on our products and markets + Leverage strength of quality system as a competitive advantage that drives profitability and customer satisfaction + Establish a learning culture that fosters knowledge transfer and best practice sharing, recognize and value these behaviors + Maintain a focus on customer engagement; proactively identify needs, solicit feedback, and address concerns in a timely manner + Represent Abbott strategically in the industry through professional associations/advocacy Specifically for Hannover site + Provide QA strategy leadership at the site + Lead Quality site activities + Manage assigned resources + ensure all site products compliance + Assist in resolving problems + Process queries from the authorities + Perform Quality Management at the site + Promote Innovation and continuous improvement Specifically for Neustadt site + Technical and personnel management of the Quality areas within Neustadt site and overall oversight of + all Quality projects + Ensure the standard quality of the products manufactured at the site in line with applicable + quality guidelines & quality systems + Assist in resolving difficulties or decision making in the subordinate areas + Support the team in quality audits by external inspectors, internal audits and processing inquiries from + the authorities, particularly on inspections **Supervisory/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 requirements + Accountable to ensure superior Quality, Compliance and financial performance and uninterrupted supply of products to the customers. + Role reports to Patricia Griffiths, DVP QA EPD **Profile 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 skills + Has 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 professionals + Knowledge of regulations and standards affecting pharmaceutical business An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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