If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Senior Manager, Quality Assurance Compliance in Boulder, CO, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. Main Duties and Responsibilities
As Senior Manager, QA Compliance you will be responsible for executing, through leadership and management, our internal audit program for identifying risk to GxP compliance and product quality within Boulder Manufacturing Center (BMC) site operations for the manufacture, testing and release of product in compliance with FDA , European and Japanese regulations including but not limited to CGMP's , ICH and FDA guidelines.
You will be responsible for routine evaluation of the effectiveness, implementation and routine management of the Astra-Zeneca quality system. Ability to develop effective audit strategy and schedule to assure all areas are periodically evaluated. Knowledgeable in Biopharmaceutical Manufacturing processing and associated support functions.
Lead and maintain a risk-based self-inspection (internal audit) program to ensure product quality as well as compliance with GxP regulations/guidelines and company quality standards across the BMC site supply chain. Perform assessments/audits of upstream and downstream manufacturing with associated support areas, Quality Control Laboratories, Warehousing, Facility Management, and supporting quality systems at the BMC site. Interpret findings from internal audits, local incidents/investigations and other internal or external assurance activities to identify emerging quality or GMP compliance trends or shortcomings in capability. Ensure Site and other relevant AstraZeneca management is informed of site compliance status and any significant issues or risks. Communicate learnings where appropriate to partner sites within the AZ network.
You will be site representative and subject matter expert (SME) for Data Integrity. Represent the QA department on cross-functional teams, ensuring that department concerns are effectively communicated. Facilitate interactions with senior management and internal stakeholders. Provide leadership and guidance to peers in the QA department and functional areas. Assist with the training activities of other QA and site staff in relation to Part 11 Compliance and Data Integrity. Support and provide key participation in US, EMA and other Regulatory Inspections.
- Bachelors Science in Engineering or directly related field
- Minimum of seven years of prior quality experience including audit.
- Risk evaluation, risk mitigation and risk based decision making across the areas of responsibility is required for success.
- Ability to conduct briefings on internal audit findings for top Boulder Manufacturing Center management.
- Ability to effectively present complex observational findings to large groups.
- Good listening, auditing and writing skills; interpersonal savvy and peer relations skills.
- Knowledge of mammalian cell monoclonal antibody production from an upstream and downstream processing perspective including working knowledge of viral and microbial contamination control strategies.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.