Senior Quality Director for Manufacturing Excellence
1 mese fa
About the Role:
We are seeking a highly experienced Senior Quality Director to lead our manufacturing quality function at GSK's Parma site. This is an exciting opportunity to drive excellence in quality and safety, ensuring compliance with regulatory requirements and delivering high-quality products to patients.
Key Responsibilities:
- Lead Quality Operations: Ensure that each batch of medicinal product is manufactured, tested, and released in compliance with laws and marketing authorization conditions.
- Maintain Product Quality: Enforce 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.
- Site Compliance: Ensure site compliance to all internal and external requirements, such as GMP for EU and all markets supplied by the site.
- Incident Management: Timely escalation and effective management of incidents; propose position with respect to market action and document rationale for decisions.
- Professional Development: Maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks.
- Audit Management: Lead role in management of all Quality audits performed on site, including all audits by regulatory agencies, customers, and corporate.
Strategy and Direction:
- Set Site Quality Strategies: Deliver on Site Quality Strategies – ensuring engagement from site leadership team.
- Quality KPIs: Establish and monitor quality KPIs, ensuring actions are taken to address trends.
- Leadership and Collaboration: 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.
- GSK Global Quality Strategy: Ensure the site remains aligned with the global quality strategy, objectives, and policies of the company.
- Quality Processes: Implement key quality processes to achieve short, medium, and long-term objectives.
- Regulatory Compliance: Ensure compliance with GSK Vaccines standards, policies, procedures, and local regulations.
- Culture and Maturity: Reinforce and sustain a Quality Excellence Mindset within all Quality operations; work in close collaboration and influence corporate partners to ensure continuous improvement of the Quality Culture and site maturity.
Budget and Financial Management:
- OPEX and CAPEX Management: Manage the OPEX and CAPEX budgets for the quality unit in line with divisional guidance and strategy.
- Departmental and Site Financial Objectives: Achieve departmental and site financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
People Management and Development:
- Safety and Security: Maintain a safe and secure work environment; lead, train, coach, motivate, and reward the management team and employees towards operational excellence and attainment of current Good Manufacturing Practices.
- Quality Organization Results: Maintain and enhance Quality organization results by communicating job expectations.
- Labor Relations: Negotiate with others to remove roadblocks and resolve disputes.
- Performance Management: Manage the unit through effective performance management and labor relations excellence.
- Talent Retention and Development: Ensure the retention, engagement, and development of key talents within the organization.
- Succession Planning: Ensure succession is in place for key roles in the network to minimize operational risks.
- Role Modeling: Be a role model for GSK quality culture.
Basic Qualifications:
- Education: University degree in a related field such as Chemistry, Pharmaceutical Manufacturing Technology, Biology, or Quality Management.
- Scientific Background: Scientific background through education and/or experience.
- Experience: 10 years of experience in Quality function in a highly regulated environment.
- Regulatory Knowledge: Understanding of regulatory requirements and expectations.
- Problem-Solving and Leadership Skills: Proven capability for problem-solving, communication, leadership, decision-making.
Preferred Qualifications:
- Degree or Certification: Degree or professional certification such as Six Sigma or Lean would be beneficial.
- Initiative and Urgency: Strong sense of initiative, urgency, pragmatism, judgment – ability to make things happen.
- Critical Thinking and Leadership: Critical thinking and leadership skills to guide teams on drawing out and prioritizing strategic questions and choices.
- Executive Capability: Executive and leadership capability to manage people.
- Interpersonal Skills: Strong Interpersonal skills, high level of resilience, and autonomous decision-making.
- Influence and Networking: Ability to influence and network internally and with external health authorities.
- Communication and Analytical Skills: Ability to express complex issues in concise and clear language; very good English (written and spoken) and Italian (desired).
- Data Analysis and Decision-Making: Ability to analyze data, identify trends, and develop solutions to improve quality and efficiency, making risk-based decisions.
About GSK:
Uniting Science, Technology, and Talent:
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.
Our Ambition:
We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.
About Our People:
We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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