Site Quality Director
GlaxoSmithKline
- Parma
- Tempo indeterminato
- Full time
- 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
- 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
- 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
- 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
- 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
- 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 level of resilience, and autonomous decision making
- Ability to influence and network internally and with external health authorities
- Ability to express complex issues in concise and clear language, very good English (written and spoken) and Italian (desired)
- Ability to analyse data, identify trends, and develop solutions to improve quality and efficiency make risk-based decisions