Site Quality Director

GlaxoSmithKline

  • Parma
  • Tempo indeterminato
  • Full time
  • 25 giorni fa
Site Quality DirectorAs 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.ParmaOur 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 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
*LI-GSKWhy Us?GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.

GlaxoSmithKline