Alexion Pharmaceuticals, Inc. · 1 month ago
Director Strategic Advice - R&D Quality Assurance
Gaithersburg
Full-time
Hybrid
Director/Executive
$150K/yr - $225K/yr
10+ years expAstraZeneca is dedicated to being a Great Place to Work, empowering employees to push the boundaries of science. They are seeking a Director of Strategic Advice to lead quality and compliance strategies in R&D, providing expert guidance and managing quality assurance programs.
BiotechnologyHealth CareMedicalTherapeutics
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
Required
Bachelor's degree required
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
Master level degree
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
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
BioWorld Financial Watch
2026-01-17
bloomberglaw.com
2025-12-20
Company data provided by crunchbase