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:
1. 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
2. Responsible & accountable for Quality & compliance in Neustadt manufacturing site and Hannover Development centre
3. Represent EPD as the key compliance/quality leader and decision maker responsible for appropriate quality outcomes for the business
4. Implement the organizational compliance/quality standards and lead the quality vision for the business
5. Implement a quality system based on sound science and application of the appropriate quality/regulatory/legal requirements
6. Drives the appropriate compliance/quality direction based on risk management principles, sound science and legal/regulatory requirements
7. Personify quality and compliance to EPD Germany external stakeholders, including regulatory agencies & Key customers
8. Demonstrate continuous improvement in the quality performance of the products and the quality system through ongoing evaluation
9. Establish long and short term strategies that ensure an effective and compliant quality vision is implemented
10. Interpret the regulations and apply the appropriate standards to the quality planning process
11. Integrate expectations for continuous improvement in quality performance into the quality/business plan
12. Ensure the organization understands the quality strategy and how it impacts the quality system
13. Allocate resources based on quality system priorities and corresponding business needs
Leadership and Problem Solving
14. Execute the EPD Germany strategy in cooperation with other functions while balancing cultural, financial and resource constraints
15. Set goals for the business that are agreed upon and supported by all functional areas to advance the business
16. Maintain high expectations of the organization and its people for the effective implementation of the quality strategy
17. Right-size infrastructure to support business growth by improving the integration of new business and divestiture of existing products and businesses
18. Create a culture of innovation and set an appropriate pace of change in response to evolving business needs and global regulatory environment
19. Apply a global perspective; act with global and local understanding of different cultures/businesses and potential impacts on our products and markets
20. Leverage strength of quality system as a competitive advantage that drives profitability and customer satisfaction
21. Establish a learning culture that fosters knowledge transfer and best practice sharing, recognize and value these behaviors
22. Maintain a focus on customer engagement; proactively identify needs, solicit feedback, and address concerns in a timely manner
23. Represent Abbott strategically in the industry through professional associations/advocacy
Specifically for Hannover site
24. Provide QA strategy leadership at the site
25. Lead Quality site activities
26. Manage assigned resources
27. ensure all site products compliance
28. Assist in resolving problems
29. Process queries from the authorities
30. Perform Quality Management at the site
31. Promote Innovation and continuous improvement
Specifically for Neustadt site
32. Technical and personnel management of the Quality areas within Neustadt site and overall oversight of
33. all Quality projects
34. Ensure the standard quality of the products manufactured at the site in line with applicable
35. quality guidelines & quality systems
36. Assist in resolving difficulties or decision making in the subordinate areas
37. Support the team in quality audits by external inspectors, internal audits and processing inquiries from
38. the authorities, particularly on inspections
Supervisory/Management Responsibilities:
39. Direct Reports: 8 - 10
Position Accountability/Scope:
40. Accountable for Quality leadership of EPD Neustadt and Hannover businesses.
41. Accountable for ensuring overall compliance to Regulations, corporate and divisional requirements
42. Accountable to ensure superior Quality, Compliance and financial performance and uninterrupted supply of products to the customers.
43. Role reports to Patricia Griffiths, DVP QA EPD
Profile requirements:
Minimum Education:
44. Science/Pharmacy Graduate. Management Degree would be an advantage.
Minimum Experience/Training Required:
45. 10 -15 years business/Quality Operations experience of which ten or more are in management.
46. Has advanced technical understanding of pharmaceutical processes, products, and procedures.
47. Must be able to establish strategic direction and lead change.
48. Has strategic organizational development skills
49. Able to develop and implement quality systems.
50. Has strong customer interface skills
51. Has appropriate level of leadership experience to lead senior Quality management staff.
52. Able to confront and resolve conflict and lead efforts to resolve critical situations.
53. Able to influence decisions of senior management and defining the Quality culture for the business.
54. Uses good judgment to make sound decisions.
55. Hires and develops strong quality professionals
56. Knowledge of regulations and standards affecting pharmaceutical business