Qualified Person (QP)

Are you ready to make a significant impact in the world of biopharmaceuticals? As a Qualified Person (QP) at Alexion, you will play a crucial role in ensuring that both licensed Finished Products and Investigational Medicinal Products (IMP) are certified and released in compliance with EU directives and Annex requirements. Your leadership will guide our operations teams in maintaining GMP compliance, ensuring the delivery of safe and effective products for commercial and clinical programs. Join us in our mission to support patients with rare diseases by overseeing and executing QP certification with precision and dedication.

Accountabilities

As a Qualified Person, you will represent internal quality operations as a subject matter expert (SME) and report to the Director of Quality Assurance Finished Product. Your responsibilities will include:

- Acting as the named QP on Alexion manufacturing licenses and performing QP release of products across the network.
- Building strategic partnerships to foster a culture of excellence in quality, compliance, and continuous improvement.
- Providing guidance on critical quality events, ensuring independence in product quality decisions.
- Partnering with Finished Product Operations and stakeholders for timely product release.
- Advising on quality performance measures in cross-functional meetings.
- Leading manufacturing and quality operations to ensure GMP compliance.
- Driving continuous improvement initiatives through lean principles and visual management.
- Offering SME input into critical deviations and change controls impacting regulatory compliance.
- Reviewing and approving manufacturing and quality documentation.
- Supporting regulatory submissions for commercial and clinical products.
- Completing QP declarations and license variation updates.
- Conducting QP review of Annual Quality Product Reviews (APQRs).
- Staying informed on pharmaceutical regulations and presenting updates.
- Providing training on compliance topics, including GMP and GDP requirements.
- Managing QP training programs for new QPs.
- Serving as an SME during regulatory inspections and audits.
- Supporting internal and external audit readiness programs.
- Managing risks identified through Risk Evaluations/Assessments.

Essential Skills/Experience

- Bachelor’s degree or higher in a scientific related field.
- Minimum 10 years GMP related experience in biopharmaceutical/pharmaceutical.
- Qualified Person status as per EU regulations or equivalent qualifications in other jurisdictions.
- Minimum 3-5 years experience operating as a named QP in a MIA/IMP manufacturing licensed facility.
- Extensive demonstrated pharmaceutical quality experience.
- In-depth Knowledge of HPRA, EU, FDA, GMP guidances and regulations.
- Experience working with aseptic and/or biotechnology products and processes.
- Experience working with Finished Product packaging activities.
- Strong leadership and communication skills, with the ability to influence and collaborate across functions.
- Proven track record of effectively managing compliance programmes and driving continuous improvement initiatives.
- Extensive experience in pharmaceutical manufacturing, quality assurance, or regulatory affairs.
- Must have strong task management skills with the ability to prioritize, schedule and deliver tasks in a fast-paced working environment.
- Demonstrated ability to be a Quality Leader, driving Right First Time culture whilst ensuring compliance.

At AstraZeneca, we are driven by our commitment to serve patients with rare diseases. Our unique approach combines the agility of a biotech with the resources of a global biopharma, fostering an environment where innovation thrives. We are dedicated to making a difference by deeply connecting with our patients, understanding their journeys, and addressing their needs. Our culture celebrates diversity, encourages new ideas, and empowers individuals to grow both personally and professionally. Join us in our mission to change lives for the better.

If you are passionate about making an impact in the lives of patients with rare diseases, we invite you to apply and become part of our dynamic team!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.