Senior Specialist, External Quality (12 month fixed term contract)

This is what you will do:

As a Senior Specialist for External Quality, you will provide essential oversight and support for quality activities related to tech transfer processes at contract manufacturing organizations (CMOs). You will ensure that quality standards are met for both clinical and commercial drug substance and drug product manufacturing. Your work will directly impact the success of tech transfer milestones and support ongoing quality assurance processes, including batch releases, change control, deviations, and CAPAs. All tasks must comply with company policies, procedures, and regulatory standards.

You will be responsible for:

• Acting as the Quality leader with the Product Development/Clinical Supply (PDCS) teams, EM&O teams, and other stakeholders to ensure on-time delivery of tech transfer projects.
• Providing oversight of GMP systems completed by CMOs and the External Supply Chain function related to Drug Substance and Drug Product.
• Reviewing contractor documents, such as batch records, deviations, and change controls, to ensure compliance with organizational procedures and standards, and track implementation.
• Guiding ongoing reviews and approvals of documentation as applicable, and providing advice on GxP within the site, with reference to guidelines and regulations.
• Approving organization-specific standard operating procedures and controlled documents issued by contract manufacturing organizations, and supporting contract manufacturing organization audits, including pre-approval inspections.
• Developing and issuing quality metrics pertaining to the process quality activities, and actively engaging in process improvements and risk assessments.
• Trending and analyzing quality aspects of technical transfer activities to measure key performance indicators, identify areas for continuous process improvements and risk mitigation, and propose and lead team implementation of appropriate CAPA.
• Reviewing and assessing deviations, including performing risk assessments, participating in root cause analysis investigations, and tracking, follow-up, and reporting/trending.
• Supporting Quality Assurance to guide various projects and technical meetings, as needed, and documenting and reporting compliance issues to management.
• Guiding early-career team members around quality processes, related digital tools, and compliance requirements.

You will need to have:

• B.Sc. degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.
•  >5 years’ cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial technology transfers .
• Understanding of pharmaceutical bulk and drug product development and manufacturing.
• Experience working with contract manufacturing/laboratory organisations essential
• Knowledge of quality management systems and regulatory requirements.
• Demonstrated ability to understand and solve complex scenarios, and make appropriate, risk-based decisions.
• Proven ability to collaborate effectively and sensitively across all levels of the organization, including senior leadership and external partners.
• Demonstrated success leading high impact business cases, implementing significant change management programs, and applying technical expertise to complex problems.
• Flexibility to travel in support of the role.

We would prefer for you to have:

• Experience in working with Contract manufacturing Organisations .
• Experience in workiing with Clinical Molecules .
• Excellent communication and interpersonal skills
• Experience in working with FDA, EMA,HPRA and PMDA regulated indutries
• Demonstrated ability in decision making, problem solving and project management. 

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.