Director of Pharmaceutical Quality System (PQS) Development Quality Global Quality Operations
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Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Are you ready to lead the charge in pharmaceutical quality systems
Join us in Development Quality a global function accountable for Good Manufacturing Practice (GMP) Quality oversight across AstraZenecas Pharmaceutical Technology & Development (PT&D) and Pharmaceutical Sciences organisations.
The role is placed at our dynamic R&D site inGothenburg.
Your role
You will provide strategic leadership and oversight within our Development Quality organisation. This pivotal role demands advanced scientific acumen comprehensive regulatory knowledge and exemplary leadership to ensure our quality systems consistently meet rigorous standards. Youll be at the forefront of enhancing PQS processes driving innovation and ensuring excellence in everything we do.
Accountabilities
Provide leadership of quality systems.
Lead the design implementation and maintenance of pharmaceutical quality systems ensuring alignment with global regulatory requirements including GMP ICH FDA and EMA. Serve as the key contact into Operations PQS.
Manage business process quality support Regional Process Champions (RPCs) and establish clear standards for effective process management and continuous improvement initiatives.
Act as a mentor to PQS RPCs and assume the RPC role for selected quality processes as needed. Motivates and guides teams through transformation initiatives fostering a culture of excellence and continuous improvement.
Oversee the collection visualisation and reporting of quality metrics ensuring senior management has access to critical data for informed decision-making.
Represent the Head of Development Quality in leading regional management reviews and serve as the Management Review RPC.
Work with Accountable Quality Site Leads to uphold Licence to Operate (LTO) requirements through diligent monitoring of relevant metrics.
Adept at developing and implementing long-term quality strategies aligned with organisational goals and regulatory frameworks.
Essential Skills/Experience
Bachelors degree or equivalent experience in an appropriate subject area.
Substantial experience working within a pharmaceutical GMP environment ideally within pharmaceutical development organisations.
Proven background in Quality Assurance Management with thorough expertise in Quality Systems and GMP or related GXP areas.
Extensive understanding of the pharmaceutical and drug development lifecycle.
Recognised expertise and authority in Quality Assurance particularly regarding GMP compliance.
Proven leader and collaborator with strong stakeholder management skills.
Experience working in a global environment.
Confident engaging partners at all organisational levels and navigating complex matrix environments.
Desirable Skills/Experience
Eligibility for Qualified Person (QP) status.
Why AstraZeneca
We are driven by a relentless pursuit of excellence. Our commitment to innovation means we are constantly searching for opportunities to add value and improve outcomes for patients. With a focus on science and evidence-based decision-making we empower our teams to foresee risks and act swiftly. Here youll find a collaborative environment where each voice matters fostering camaraderie and shared knowledge. Our inclusive community encourages growth and offers exposure to exciting new products and technologies. Join us as we continue to make a real-life difference for patients worldwide.
Ready to make an impact Apply now and become part of our journey towards excellence! We look forward to your application no later than April 7 2026.
About AstraZeneca Gothenburg
Our stunning campus in Gothenburg is an incredibly vibrant and diverse place with about 3000 employees and a high proportion of international talent. Inclusion and diversity are embedded into everything we do driving creativity and people empowered to innovate for patients by challenging conventional thinking. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas weve built a series of environments where innovation can happen.
Our Gothenburg site: AstraZeneca on LinkedIn we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility.
Date Posted
24-mars-2026Closing Date
07-apr.-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Director
Key Skills
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
