Senior Quality Advisor

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 outstanding skills with those of people from all over the globe.

Our Gaithersburg, Maryland facility builds life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 guides in our field, and it is only a short drive from Washington, DC. It is filled with groundbreaking technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

Join AstraZeneca and help us deliver life-changing medicines! Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in BioPharmaceuticals.

• What you'll do: As a Senior Quality Advisor you will report to the Director of Lot Disposition and play a pivotal role in managing the development, implementation and sustainment of the Quality Processes and Systems relating to BioPharmaceuticals products. This position will also support the Cell and Gene Therapy program. This is an exciting opportunity to be part of the quality oversight of the drug development life cycle process.

Main Responsibilities :

• Perform Quality disposition of clinical supplies; review of batch records, supporting documentation and addressing product quality issues and possible non-conformances as they occur.
• Supports and provides advice to several functional areas including Logistics Clinical Supply, Regulatory Affairs, Manufacturing, IT, and other Quality departments.
• Interpret external regulatory standards and expectations into appropriate quality standards and provide guidance to project teams or functions to ensure overall that compliance with AstraZeneca and Regulatory requirements are met.
• Lead continuous and quality improvement efforts in line with GMP regulations via tracking and trending of site metrics.
• Drive out any non-value adding activities, support Lean operations and support line management to develop a culture of continuous improvement.
• Develop, validate, and deploy relevant computerized systems and computerized system upgrades.
• Acts as a mentor to promote a culture of ethics, diversity, inclusion, integrity, and continuous improvement that focuses on delivering efficiencies and planned business benefits.
• Project Management of local projects with global impact.
• Maintain internal controls over quality policies and procedures.
• Assist during Internal/External Inspections.
• Manage projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs.
• Author or provide quality mentorship in the handling of nonconformance and CAPAs for assigned products and quality systems.
• Collaborate with stakeholders to address development, risk management, change control, quality, or auditing activities.
• Effectively utilize Operational Excellence tools such as FMEA, DMAIC and root cause analysis.

Minimum Requirements :

• Bachelor's Degree in appropriate scientific field. Master's degree is desirable for Senior Quality Advisor role.
• Minimum of ten (10) years of Quality experience working in the pharmaceutical and/or biotechnology field.
• Experience writing and reviewing SOPs and other quality documents.
• A broad and comprehensive understanding of investigational medicinal products.
• A strong understanding of the pharmaceutical/drug development process.
• Experience working in Quality within large or small molecules.
• Demonstrated knowledge of Quality Assurance activities and ICH and FDA/EU GxP regulations as they relate to clinical studies trials, product development, manufacturing, and technology transfer.
• Outstanding interpersonal, problem- solving, and written/verbal communication skills.
• Experience working with Inventory Control Management System.
• Excellent communication skills with an ability to manage stressful and confrontational situations and move them to positive outcomes.
• Excellent team working and networking skills to encourages team effectiveness; ability to lead and inspire colleagues.

Preferred

• Demonstrates independent judgement and uses risk management in complex situations.
• Capable of making decisions, acting courageously, and communicating with conviction and inspiration.
• A good communicator with experience of interacting effectively across interfaces collaborating internally.
• Builds excellent relationships both internally and with external suppliers or service providers.

• Well-developed knowledge of electronic quality systems (e.g., ECMS, SAP, PMD)
• Methodical
• Excels in a fast-paced team environment, results oriented and prioritizes work while multitasking.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being bold - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking innovative methods and bringing unexpected teams together. Interested? Come and join our journey.

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.