Site Quality Director

2 settimane fa

Parma, Italia GSK A tempo pieno

**Site Name**: Italy - Parma

**Posted Date**: Apr 2 2024

**Site Quality Director**:
As Site Quality Head for Parma, you will be responsible for the site's overall performance regarding quality. You will lead a talented team, guiding them to deliver high-quality products and ensuring that site’s operations meet internal and external quality, safety, and environmental standard. This role is pivotal in shaping the quality culture within site organization and driving continuous improvement and excellence.

**Parma**:
Our Parma site plays a crucial role in the GSK network, focusing on launching new products and manufacturing various dose forms, primarily steriles. It is a node of excellence and innovation.

**Key responsibilities**:
**Manage Quality Unit Operations**:

- Ensures that each batch of medicinal product is manufactured, tested and released in compliance with the laws and conditions of the marketing authorization of the medicine
- Maintain product quality by enforcing compliance to local SOPs, Quality Policies, Guidelines, and Processes, as well as regulatory requirements; review and act upon adverse quality trends and product/process quality reports
- Ensure site compliance to all internal and external requirements, such as GMP for EU/ for all markets supplied by the site
- Timely escalation and effective management of incidents; propose position with respect to market action and document rationale for decisions
- Maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks
- Take lead role in management of all Quality audits performed on site, including all audits by regulatory agencies, customers and corporate

**Strategy and Direction**:

- Sets and delivers on Site Quality Strategies - ensuring engagement from site leadership team.
- Ensure site operate in status of control establishing and monitoring quality KPI and ensuring actions are taken to address trends
- 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
- Achieve departmental and site financial objectives by preparing the quality assurance budget, scheduling expenditures, analysing variances, and initiating corrective actions

**People Management and Development**:

- Maintain a safe and secure work environment. Lead, train, coach, motivate and reward the management team and employees towards the pursuit of operational excellence and attainment of current Good Manufacturing Practices
- Maintain and enhance Quality organization results by communicating job expectations.
- Negotiate with others to remove roadblocks and resolve disputes
- Use GPS tools to drive improvement
- Manage the unit through effective performance management and labour relations excellence
- Ensure the retention, engagement, and development of key talents within the organization
- Maintain Quality Assurance staff by recruiting, selecting, orienting, and training new employees
- Ensure succession is in place for key roles in the network to minimize operational risks
- Lead, inspire and engage workforce creating an environment where everyone can thrive
- Be a role model for GSK quality culture

**Basic Qualifications**:

- University degree in a related field such as Chemistry, Pharmaceutical Manufacturing Technology, Biology or Quality Management
- Scientific background, through education and/or experience
- 10 years of experience in Quality function in a highly regulated environment
- Understanding of regulatory requirements and expectations
- Proven capability for: problem solving, communication, leadership, decision-making

**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:

- Degree or professional certification such as Six Sigma or Lean would be beneficial
- A strong sense of initiative, urgency, pragmatism, judgment - an ability to make things happen
- Critical thinking and leadership skills will allow to Guide teams on drawing out and prioritizing strategic questions and choices
- Executive and leadership capability to manage people
- Strong Interpersonal skills, high leve

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