Head of Global Data Integrity & Data Management (Pharma)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Head of Global Data Integrity & Data Management (Pharma): Developing and maintaining a global data integrity program to ensure compliance with regulatory requirements like FDA and EMA with an accent on data governance, risk management, and GxP standards. Focus on implementing standardized policies for data lifecycle management, mitigating data-related risks, and driving a culture of proactive compliance across GMP/GDP functions.
Location: Hybrid in Parma, Italy
Company
is an international research-focused biopharmaceutical group operating in over 30 countries with a focus on sustainable innovation and healthcare.
What you will do
- Lead the global strategy for data integrity, ensuring alignment with regulatory expectations and internal quality standards.
- Develop and implement standardized policies and procedures for data governance and data lifecycle management.
- Own the global data risk management program to identify and mitigate risks related to data accuracy, completeness, and security.
- Ensure compliance with global regulatory requirements, including FDA, EMA, MHRA, WHO, and PIC/S.
- Collaborate with production sites, CMOs, and IT functions to ensure consistent implementation of data integrity practices.
- Provide guidance and training to global and local teams to foster a culture of accountability.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Data Science, or Quality Management.
- 15+ years of experience in quality systems, data governance, and regulatory compliance within the pharmaceutical industry in global roles.
- Deep understanding of data integrity principles, GxP requirements, and regulatory expectations.
- Proven track record in managing data-related risks and implementing governance frameworks.
- Strong project management, communication, and stakeholder engagement skills.
- Must be based in or able to relocate to Parma, Italy.
Nice to have
- Familiarity with digital quality systems such as Veeva, TrackWise, or SAP.
- Experience with data analytics tools and methodologies for risk identification.
- Ability to make risk-based decisions when analyzing complex data issues.
Culture & Benefits
- Comprehensive healthcare programs and competitive salary package with performance bonuses.
- Work-life balance initiatives and flexible working arrangements, including remote options.
- Robust relocation support and tax assistance services for foreign colleagues.
- A dynamic, friendly environment with access to continuous resources and training.
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