Abbott is hiring a

Senior Director Quality Assurance

Neustadt am Rübenberge, Germany

JOB DESCRIPTION:

Abbott Established Pharma Division (EPD) is looking for a

Senior Director Quality Assurance (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

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

Germany > Neustadt : 136

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES: