Sr Director, Head of Quality and Compliance - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 1 semana

Publicado por:

Isabel García

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Descripción

Are you ready to be part of the future of healthcare? Are you able to think big, be bold, and harness the power of digital and AI to tackle longstanding life sciences challenges? Then Evinova, a new health-tech business part of the AstraZeneca Group might be for you

Transform billions of patients' lives through technology, data, and pioneering, ways of working. You're disruptive, decisive, and transformative. Someone who's excited to use technology to improve patients' health. We're building a new health-tech business - Evinova, a fully-owned subsidiary of AstraZeneca Group.

Evinova delivers market-leading digital health solutions that are science-based, evidence-led and human experience-driven. Thoughtful risks and quick decisions come together to accelerate innovation across the life sciences sector.

Be part of a diverse team that pushes the boundaries of science by digitally empowering a deeper understanding of the patients we're helping.

Launch impactful digital solutions that improve the patient experience and deliver better health outcomes.

Together, we have the opportunity to combine deep scientific expertise with digital and artificial intelligence to serve the wider healthcare community and create new standards across the sector.

The Head of Quality and Compliance will establish and oversee the Evinova's quality management and compliance strategy, policies, procedures and operations.

They will be responsible for the initial accreditation and ongoing maintenance of essential certifications including GAMP Software Category 5 (GxP), ISO 27001, ISO 13485, SOC-2, ICH GCP, FDA 21 CFR Part 11, and HIPAA.

The role will collaborate closely with the Head of Cyber Security and Head of Data Privacy to ensure compliance with NIST Cyber Security Framework (CSF), NIST SP 800-53, EU GDPR, France CNIL, China PIPL, Russia 152-FZ and other relevant information security and data privacy regulations.

The expectations of the role will expand with the maturity of the Evinova business with a clear focus on delivering high-quality, compliant products and services with industry-leading, highly automated, and efficient practices.

This includes active participation in external industry forums, consultation and engagement with regulators, and collaboration with customers pre and post-sales.

The role will represent the company in vendor qualification, routine audits, and health authority inspections where applicable.

This role presents an opportunity to join Evinova from the beginning, designing and implementing new, innovative approaches to Quality and Compliance that are designed by industry, for industry.

Leads the Quality and Compliance function with a clear mandate to deliver a highquality, compliant set of products and services to customers globally
Drives the overall development, implementation and operational oversight of quality and compliance strategy, policies and procedures collaboratively with the Privacy, Cyber Security, Product, Tech, and Science functions
Promotes and enforces compliance with established quality systems, operating procedures and proactively leads change as external regulations and best practices emerge
Leads endtoend efforts for external accreditation/certifications, customer qualification audits, routine customer audits, and routine health authority inspections
Oversees the tactical implementation of leadership decisions and ensures alignment with desired outcomes.
Provides seniorlevel assurance and attestation of product validation status and overall externallyregulated compliance status
Champions innovative approaches to quality and compliance both internally and externally with clearly established key performance indicators (critical metrics), objectives for continuous improvement, and longterm strategic goals emphasizing automation, efficiency, and proactive risk management
Embraces a customercentric, impactful, right problem / right solution engineering approach and culture.
Handles and balances legal risk by understanding current and emerging industry regulations and taking proactive action to modify internal quality and compliance policies and procedures
Establishes baseline metrics and actively optimizes the cost profile of Quality and Compliance as a percentage of revenue and minimizes the process burden for ongoing product development and service delivery
Continuously updates knowledge by participating in educational opportunities, reading professional publications, and participating in professional organizations
Actively participates in product strategy and roadmap development, ensuring quality and compliance requirements are represented and balanced with new capability development
Other duties as assigned

Minimum Qualifications:

BA/BSc and extensive experience in multiple areas of quality and compliance within a Pharmaceutical/Biotech environment
10 years of proven experience
Knowledge of industry good practices and st