Regional Clinical Quality Manager - São Paulo/Brazil

AstraZeneca; Brasil; In loco; BRL 600.000 - 1.000.000; Tempo pieno

Descrizione del lavoro

AstraZeneca seeks a Regional Clinical Quality Associate Director to guide quality across Oncology trials, aligning regional plans with country actions and ensuring GCP compliance and inspection readiness. You will drive risk-based oversight and coordinate with SMM, CRO partners, and global QA peers.

You will lead regional quality plans, monitor metrics, and mentor teams, fostering continuous improvement in a global, remote-enabled environment.

Competenze

• Undergraduate degree in life sciences or equivalent.
• Fluent in English and Portuguese; Spanish is a plus.
• Advanced degree in life sciences is desirable.
• Pharma industry experience in a GxP regulated environment.
• Strong communication and cross-functional networking abilities.
• Knowledge of ICH-GCP and drug development processes.

Mansioni

• Serve as primary quality contact for SMM and CRO partners; ensure GCP and AstraZeneca standards.
• Develop regional quality plans and annual QC activities across countries.
• Track quality metrics, identify trends, and drive CAPA actions.
• Provide regulatory guidance and SOP expertise to regional teams.
• Coordinate audits, inspections, and risk-registries with stakeholders.
• Lead knowledge sharing and capability building across regions.

Conoscenze

Fluent in English

Fluent in Portuguese

Spanish desirable

GxP knowledge

ICH-GCP knowledge

Strong communication

Formazione

Undergraduate degree in life sciences or equivalent

Advanced degree in life sciences desirable

Descrizione del lavoro

Are you ready to raise the bar on clinical quality across a high-impact Oncology portfolio and see your decisions translate into reliable studies and better outcomes for patients? Do you thrive at the intersection of regional strategy, country-level execution, and hands-on collaboration with FSP partners?

As Regional Clinical Quality Associate Director, you will be the first line of guidance on quality and compliance for countries supported by our functional service providers. You will connect regional insight with country action-building metrics-driven oversight, sharpening risk intelligence, and ensuring our studies are inspection-ready. Your work will empower site management and monitoring teams and our CRO partners to apply GCP principles confidently and consistently, so that every trial delivers dependable evidence when it matters most.

Accountabilities:

• First-line Quality Leadership: Serve as the primary point of contact on quality and compliance for FSP-supported Site Management and Monitoring in Oncology and our CRO partners; provide clear direction on applying GCP and AstraZeneca standards so trials are robust and inspection-ready.
• Regional Quality Strategy: Develop regional and country quality plans and manage the annual regional quality control plan, embedding a proactive, risk-based focus on quality across assigned countries. Included is ensuring change management principles and documentation is completed as required for all SMM operational activities that qualify.
• Metrics and Risk Intelligence: Develop, track, and analyze quality metrics at regional and country level; identify trends early, anticipate deviations, and drive timely corrective and preventive actions.
• Regulatory and SOP Expertise: Investigate and consult on local regulatory guidance; apply expert knowledge of global standards and SOPs to deliver actionable compliance advice to regional and country teams.
• Stakeholder Partnership: Maintain continuous exchange with regional SMM, and country study teams to surface risks, calibrate oversight, and coordinate mitigations.
• Training and Capability Building: Assess training gaps, facilitate and support onboarding and targeted learning; collaborate on communication of global process updates promptly to secure adoption and consistency.
• Culture and Continuous Improvement: Foster an engaging quality culture; recommend and implement practical compliance improvements; amplify cross-learning from audits, inspections, and quality reviews.
• Inspection and Audit Readiness: Consult during RIST activities, inspections, and audits; coordinate internal audits where appropriate.
• Governance and Risk Management: Lead or support quality review meetings; facilitate regional and country risk registers; manage risk plans, elevate issues appropriately, and ensure mitigations are executed and tracked.
• Cross-Functional Quality Network: Collaborate closely with the regional Quality directors and broader quality community to synchronize trends, issues, and solutions across countries and processes.
• Leadership Engagement: Participate in SMM leadership meetings; enable consistent, high-quality oversight across the portfolio and drive shared accountability.
• Knowledge Sharing: Seek feedback from leadership and clinical operations, promote knowledge exchange, and embed lessons learned to lift standards across regions.

Essential Skills/Experience:

• Undergraduate degree in life sciences or an equivalent related discipline.
• Fluent in English and Portuguese.
• Advance in Spanish is desirable.
• In-depth knowledge and broad experience within the pharmaceutical (biopharma) industry in a GxP regulated environment.
• Excellent communication skills with a proven ability to effectively network cross functionally and globally.
• Critical thinking, influencing and communication skills.
• Ability to collaborate, network and interact widely and effectively at all levels.
• Strong risk-based decision-making skills.
• Excellent understanding of the drug development process and related GXP activities
• Excellent understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management.
• Excellent knowledge of international regulations and guidelines, as well as AZ Procedural Framework
• Good analytical, problem solving, negotiation and conflict resolution skills. Ability to multi-task.
• Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global environment.
• Ability to collaborate proactively, deal with ambiguity, ability to build strong customer relationships and strategic working partnerships to operate across multiple domains enabling process and system harmonization and standardization.

Desirable Skills/Experience:

• Advanced degree in life sciences or an equivalent related discipline.
• Experience working with global and remote cross functional teams.
• Ability to work in an environment of remote collaborators.
• Training expe