Senior Quality Assurance Manager - United Kingdom - AstraZeneca

Description

Location – RemoteDuration – 12 monthsMake a meaningful difference at AstraZenecaBring out the best in each other, and yourself, by working together as one.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.

In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our unique and ambitious world.​At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges.

We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.

We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.

Main Duties and Responsibilities:

In this role, you will proactively ensure GMP and regulatory compliance during the planning, execution and close out phases of supplier related projects.

You will be responsible for the Quality System oversight of:

Supplier Selection processes, Technical Transfers, Validation, Audits, Change Controls, Deviation investigations, issue management and escalation, and the development of Quality Agreements between AstraZeneca and External Suppliers.

The preparation and submission of Supplier Quality Risk Assessments, and support to Regulatory Agency inspections of supplier sites.

You will drive quality improvements at the supplier as part of a cross functional team and provide authoritative QA advice to projects.

The incumbent will support identifying, assessing and establishing suppliers, within External Quality; making decisions and/or providing advice to Supplier Management / Project Management Teams regarding quality and pharmaceutical technology issues within their area of expertise.

This role will also include the quality review and approval of Chemistry and Manufacturing Control (CMC) documents associated with changes or product establishment at suppliers.

Key Accountabilities Actively ensures GMP and regulatory compliance during the planning, execution and closeout phases of New Product Introduction and Commercial Supply Chain projects at aligned Supplier(s).Maintains a high level of understanding of applicable small and large molecule production processes and quality systems.

Performs the Quality review and/or approval of cGMP documentation for their suppliers, including:

QA Agreements, Change Controls, Quality Investigations, Validation Plans, Protocols and ReportsDevelops and maintains effective business relationships with SuppliersSupporting and participating in Regulatory Agency inspections of their suppliers.

Responsible for quality issues escalation and resolution at the Suppliers, to ensure right product at the right time is delivered into the Product Supply Chain.

Collaborates in data analysis and development of quality metrics and key performance indicators.


Essential skills & experience:

Degree in a science / technical field such as Pharmacy, Biology, Chemistry, Engineering or equivalent experienceBroad experience with a minimum of 5 years relevant work experience in either the pharmaceutical operations environment or a pharmaceutical Quality Assurance roleExcellent oral and written communication skillsStrong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environmentWe are an equal opportunity employer and value diversity at our company.

We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

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.