Site Quality Head Dresden

vor 2 Monaten

Dresden, Deutschland GSK Vollzeit

**Site Name**: Dresden - Office

**Posted Date**: Apr 26 2023

As Site Quality Head, Dresden you will be responsible for the site's overall performance regarding quality, as well as for the motivation and the social climate at the site. In this role, you ensure that customer requirements are achieved while adhering to all internal and external quality, safety, and environmental guidelines to assure compliance, continuous improvement, and sustainable growth.

**Dresden**

GlaxoSmithKline Biologicals is located in the heart of the city of Dresden and manufactures vaccines for the world market: The seasonal flu vaccine is distributed in around 70 countries. In addition to the production of seasonal and pandemic influenza vaccines, the formulation and filling of hepatitis vaccines completes the portfolio of the Dresden plant. Around 750 employees plus trainees work at this location.

**Key Responsibilities will be**:
**Manage Quality Unit operations**:

- Lead the quality organization & manage the quality system to comply with cGMP and other applicable regulations for biological products in a cost-effective way.
- Maintain up-to-date knowledge
- Monitor and improve quality performance through Key Performance Indicators
- Be proactive in anticipating improvements to current quality processes while ensuring Change Control.
- Ensure the efficient and flexible use of resources to achieve both customer satisfaction and cost.
- Ensure facilities are managed in accordance with GSK Vaccines and GSK quality standards.

**Strategy and Direction**:

- Provide leadership of the site through effective partnering with the site head to deliver a high compliance, quality focused site to ensure superior business performance. Develop and propose the annual Quality Plan covering short and long-term plans to enhance the overall quality performance of the site/.
- Ensure the site remains aligned with the global quality strategy, objectives and policies of the company.
- Implement key quality processes to achieve short, medium
- and long -term objectives,
- Ensure compliance with GSK Vaccines standards policies, procedures, and local regulations,
- Reinforce and sustain a Quality Excellence Mindset within all Quality operations.
- Work in close collaboration and influence corporate partners and ensure continuous improvement of the Quality Culture and site maturity

**Budget**:

- Manage the OPEX and CAPEX budgets for the quality unit in line with divisional guidance and strategy.

**Adverse Events**:

- Organize the activities to reduce the impact of any adverse event on product quality and business operations by ensuring the maintenance and the development of excellence in quality operations.

**People Management and Development**:

- Lead, train, coach and motivate the management team and employees towards the pursuit of operational excellence and attainment of current Good Manufacturing Practices,
- Manage the unit through effective performance management and labour relations excellence,
- Ensure the retention, engagement and development of key talents within the organization.
- Ensure succession is in place for key roles in the network to minimize operational risks.

**GSK image/Lobbying**:

- Act as a site spokesperson outside the site, promoting the quality of the work done at the site. Being the “Voice of the site” (spokesperson) influencing Quality decisions at Global level (e.g. QMS), supporting VP Quality Operations in this role”

**Quality assurance activity**:

- Ensure rapid and effective analysis and resolution of all quality related issues.
- Ensure adequate resources and training to ensure capacity and expertise in quality operations.
- Develop quality mindset in the unit: achieve quality in everything we do.
- Establish quality related KPIs and make them visible.

**Site conformance**:

- Ensure adequate Site regulatory compliance to maintain registered licenses and achieve new product registration.

**Quality Control and laboratory activity**:

- Ensure sampling, documentation and analytical testing of incoming materials, intermediates, and product at all stages. Ensure the development and the maintenance of a cost-effective laboratory quality system which ensures laboratory compliance and delivers testing aligned to the overall business requirements.

**EHS**:

- Continuously improve environmental, health and safety performance to achieve EHSS Excellence.

**Change and Process Management**:

- Provide leadership for change initiatives involving processes, technologies and people which contribute to the overall effective improvement of Site Quality

**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- Master’s/PhD degree in a related field such as pharmaceuticals, quality management, or business
- Several years of experience working in quality and operational management or related roles.
- Strong experience developing and implementing quality managem

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