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AstraZeneca · 1 month ago

Director Strategic Advice - R&D Quality Assurance

US - Gaithersburg - MD

Full-time

Hybrid

Director/Executive

$150K/yr - $225K/yr

10+ years exp

AstraZeneca is a leading pharmaceutical company dedicated to transforming ideas into life-changing medicines. They are seeking a Director of Strategic Advice to provide leadership in quality and compliance within their R&D Quality Assurance team, influencing strategic directions and managing regulatory inspection strategies.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

Responsibilities

Work closely with stakeholders in R&D providing leadership in influencing strategic direction on quality and compliance through responsive and proactive GCP/GVP expert advice related to clinical and post-market activities including risk management

Deliver end-to-end regulatory inspection strategy and management

Manage business relationships with defined stakeholder groups and senior leaders in R&D, and for the strategic development and delivery of a GxP risk-based robust quality assurance program and quality management activities for these stakeholders

Lead or participate in the investigation of critical quality issues and ensure timely reporting of issues to relevant authorities, where applicable

Lead training for colleagues and business stakeholders

Support or lead the development and/or revision of QA processes, projects, and tools

Generate simple solutions to complex challenges while having a ‘solutions focused’ attitude

Qualification

GxP GVPGxP GCPQuality Assurance ManagementRegulatory Inspection ManagementSix Sigma/LeanProject ManagementAnalytical SkillsWrittenStakeholder ManagementTechnology ManagementInterpersonal SkillsOral Communication

Required

Bachelor's degree required, Master level degreed preferred

10+ years experience in pharmaceuticals or a related life-science industry required

A thorough understanding and experience of GxP (GVP and GCP) and quality assurance/management

Strong collaborative, influencing, and interpersonal skills, curious to understand business environment

Excellent analytical, written and oral communications skills

Proficient in written and spoken English

High ethical standards, trustworthy, operating with absolute discretion

Skilled at managing & using technology, curious regarding AI

Ability to maintain and create professional networks with stakeholders

Experience in managing regulatory health authority GxP Inspections

Preferred

Project management

Key Account management

Experience in Six Sigma/Lean/Process improvement tools

Quality and Audit expertise

Benefits

Medical & life insurance

Annual bonus

Education cost reimbursement

Occasional allowances (Christmas, holiday)

Anniversary awards

Additional time off

Pension plan

Business travel insurance

Recognition program

Flexible working hours

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees