Director Quality Germany Operations

Abbott Laboratories; Neustadt am Rübenberge; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der pharmazeutischen Industrie sucht einen Director Quality für die Operations in Deutschland. In dieser Schlüsselposition sind Sie verantwortlich für die Entwicklung und Umsetzung der Qualitätsstrategie am Standort Neustadt sowie im Hannover Development Centre. Sie leiten ein Team von 8-10 Personen und stellen sicher, dass alle Produkte den höchsten Qualitätsstandards entsprechen. Ihre Fähigkeit, strategische Richtungen zu setzen und Veränderungen zu führen, wird entscheidend sein, um die Qualität und Compliance in einem dynamischen Umfeld zu gewährleisten. Wenn Sie eine Leidenschaft für Qualität und Führung haben, ist dies Ihre Chance, einen bedeutenden Einfluss zu nehmen.

Qualifikationen

• 10-15 Jahre Erfahrung in Qualitätsoperationen, davon mindestens 10 Jahre in Führungspositionen.
• Fortgeschrittenes technisches Verständnis von pharmazeutischen Prozessen und Produkten.

Aufgaben

• Verantwortlich für die Qualität und Compliance am Standort Neustadt und Hannover.
• Führen der Qualitätsstrategie und der Qualitätsvision für das Unternehmen.

Kenntnisse

Qualitätsmanagement

Pharmazeutische Prozesse

Strategische Planung

Risikomanagement

Kundenbeziehungsmanagement

Führungskompetenz

Ausbildung

Abschluss in Naturwissenschaften oder Pharmazie

Managementabschluss

Jobbeschreibung

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