Chiesi Group ir pasaules mēroga farmācijas uzņēmums, kas koncentrējas uz inovatīvu zāļu izpēti, izstrādi un komercializāciju. Tā darbība aptver elpceļu slimības, specializēto aprūpi un retās slimības, plašākā mērķī cenšoties uzlabot pacientu veselību un labklājību. Uzņēmums savā pieejā veselības aprūpei īpašu uzmanību pievērš arī ilgtspējai, korporatīvajai atbildībai un vides aizsardzībai.
Head of Global Operational Compliance
Lead global pharmaceutical quality operations across Chiesi Group’s manufacturing sites, based in Parma. Align quality systems, validation, and regulatory compliance while advancing continuous improvement.
Itālija73 000 € – 100 000 € / gads
HibrīdiPilna slodzeVadošais speciālistsNepieciešamā Valoda: angļuAtbilstībaApraksts
- Oversee quality operations across manufacturing facilities and laboratories.
- Maintain consistent product quality across Chiesi Farmaceutici S.p.A. sites.
- Track quality KPIs and address global quality matters.
- Manage potential non-conformities, deviations, and change control.
- Set guidance for validating systems and processes under national and international GMP regulations.
- Oversee compliance with validation processes.
- Contribute to Validation Project Plans and Validation Final Reports.
- Set objectives and timelines, assess data, and coordinate corrective actions.
- Work with site Quality Directors on business continuity assessments, corporate audits, and inspections by authorities.
- Align quality processes and coordinate local and global Quality Councils.
- Partner with Compliance teams to ensure quality standards meet internal and regulatory requirements.
- Guide teams and promote a culture of quality excellence.
- Report to the Global Quality Operations Vice President.
- Lead a small team.
Prasības
- Hold a degree in a scientific discipline.
- Bring at least 15 years of experience in pharmaceutical quality assurance.
- Have at least 10 years of leadership experience.
- Demonstrate a strong record in quality operations and management.
- Bring deep knowledge of quality management systems, compliance standards, and pharmaceutical regulatory requirements.
- Have experience engaging with authorities in the EU, US, and other regions, including EMA and FDA.
- Speak and write English fluently.
- Show strong leadership and collaboration across multiple sites.
- Bring experience in change management and governance framework development.
- Have excellent relationship-building and communication skills.
- Be able to analyze processes, anticipate challenges, and implement effective solutions.
Priekšrocības
- Annual bonus based on company and individual performance.
- Company car.
- Pension.
- Private medical insurance.
- Wellbeing programme.
- Flexible benefits programme.
- Comprehensive healthcare programmes.
- Work-life balance initiatives.
- Relocation support.
- Flexible working arrangements.
- Remote work options.
- Tax assistance for foreign colleagues.
- Access to resources and training.
- Performance bonuses.