Director Strategic Advice - R&D Quality Assurance
Company: AstraZeneca
Location: Montgomery Village
Posted on: January 29, 2026
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Job Description:
Do you have expertise in, and passion for Quality? Would you
like to apply your expertise influencing strategic directions on
quality and compliance being the GVP/GCP expert related to clinical
and post-market activities in a company that follows the science
and turns ideas into life changing medicines? Then AstraZeneca
might be the one for you! At AstraZeneca we’re dedicated to being a
Great Place to Work. Where you are empowered to push the boundaries
of science and unleash your entrepreneurial spirit. There’s no
better place to make a difference to medicine, patients and
society. An inclusive culture that champions diversity and
collaboration. Always committed to lifelong learning, growth and
development. We are now recruiting for a Director Strategic Advice
position to join our Strategic Advice team within R&D Quality
Assurance. R&D QA is an independent global quality assurance
function in AstraZeneca R&D maintaining the R&D Quality
Management System and assessing quality based audits, inspections
and self-reported quality issues. We promote and strive towards a
state where everyone acknowledges that quality is a competitive
advantage, and that quality arises from every individual’s
contribution to a ‘right-from-me’ mentality. If you enjoy
challenging the way things are done and want to pioneer a new
future to meet global healthcare challenges this is the place for
you. This position is based out of our Gaithersburg, MD office and
will follow a hybrid work schedule. What you’ll do 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. Essential for the role 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 Desirable for
the role Project management Key Account management Experience in
Six Sigma/Lean/Process improvement tools Quality and Audit
expertise What you can expect: great working atmosphere empowering
you to reach your full potential, endless development opportunities
and benefits like: 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. Why AstraZeneca? At AstraZeneca you will be valued. Not only
for your unique contribution, skills and background, but because we
recognize people are our greatest asset. Here we are dedicated to
being a Great Place to Work. Thrive in an energizing environment
where challenging work goes hand in hand with development. With
opportunities, recognition and bright minds, there’s no better
place to unlock learning and build a long-term career. Most
importantly, we do meaningful work that changes lives. It’s our
purpose that drives us, every day. Interested? Come and join our
journey. The annual base pay for this position ranges from
$150,227.20 - $225,340.80 USD. Our positions offer eligibility for
various incentives—an opportunity to receive short-term incentive
bonuses, equity-based awards for salaried roles and commissions for
sales roles. Benefits offered include qualified retirement
programs, paid time off (i.e., vacation, holiday, and leaves), as
well as health, dental, and vision coverage in accordance with the
terms of the applicable plans.
Keywords: AstraZeneca, Montgomery Village , Director Strategic Advice - R&D Quality Assurance, Healthcare , Montgomery Village, Maryland
