388688BR
Apr 05, 2024
Turkey
About the Role
• Ensure that all aspects of the handling, manufacturing, testing, release of products at the site are compliant with GMP, GDP, Corporate Standards and any applicable local/international Regulatory Standards.
• Staff, train, and develop the quality department
• Provide leadership, direction and support to the people within the Quality department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Co-ordinate with other members of the management's operating team in the day-to-day conduct of the site's business.
• Develop and implement processes to improve quality, demonstrate ongoing control and cost efficiency.
• Maintain, along with your team the plant in a validated state.
• Participate in, respond to all Health Authority, internal and external audits, and be the site responsible for this matter. Be the Quality spokesperson during external audits.
• Prepare, present and manage the budget for operational expenses, headcount and capital investments
• Ensure adequate management of product critical quality issues (deviations, out of specifications). Ensure investigations are accurately executed and adequate CAPAs are defined, and accurately follow up of CAPAs efficiency.
• Define, implement, supervise, consolidate, and analyze Site Quality KPIs. Drive for Site management team accountability.
• Staff, train, and develop the quality department
• Provide leadership, direction and support to the people within the Quality department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Co-ordinate with other members of the management's operating team in the day-to-day conduct of the site's business.
• Develop and implement processes to improve quality, demonstrate ongoing control and cost efficiency.
• Maintain, along with your team the plant in a validated state.
• Participate in, respond to all Health Authority, internal and external audits, and be the site responsible for this matter. Be the Quality spokesperson during external audits.
• Prepare, present and manage the budget for operational expenses, headcount and capital investments
• Ensure adequate management of product critical quality issues (deviations, out of specifications). Ensure investigations are accurately executed and adequate CAPAs are defined, and accurately follow up of CAPAs efficiency.
• Define, implement, supervise, consolidate, and analyze Site Quality KPIs. Drive for Site management team accountability.
Diversity & Inclusion / EEO
Olağanüstü, dahil edici bir çalışma ortamı sunmak ve hizmet verdiğimiz hastalar ile toplulukları temsil eden çeşitli ekip temsilcileri oluşturmaya kendini adamıştır.
Role Requirements
• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or related field. (Advanced degree is preferred.)
• Minimum of 10 years’ experience in an operational GxP area, in Manufacturing/Development or Quality.
• Profound experience leading sophisticated quality organizations in a diverse global matrix environment.
• Ability to speak up and to take Quality decisions during challenging situation.
• Strong leadership skills with excellent interpersonal, communication and negotiation abilities. With confirmed experience in change management and integration of teams and/or organizations.
• Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership and project management experience.
• Ability to work independently and effectively in international, complex and multifaceted environments.
• Advanced level of writing/speaking skills in English.
• Minimum of 10 years’ experience in an operational GxP area, in Manufacturing/Development or Quality.
• Profound experience leading sophisticated quality organizations in a diverse global matrix environment.
• Ability to speak up and to take Quality decisions during challenging situation.
• Strong leadership skills with excellent interpersonal, communication and negotiation abilities. With confirmed experience in change management and integration of teams and/or organizations.
• Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership and project management experience.
• Ability to work independently and effectively in international, complex and multifaceted environments.
• Advanced level of writing/speaking skills in English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Operations
QUALITY
Turkey
İstanbul
Novartis Turkey
Tam Zamanlı
Daimi
Hayır
