Alexion Pharmaceuticals Associate Director, R&D Quality Excellence in Boston, Massachusetts
**This position can be remote/virtual, based anywhere in the United States, and may require up to 10% travel to existing Alexion sites.
As part of the R&D Quality Excellence Team, drive Quality Culture with R&D stakeholders, through learning, embedding quality mindset, and continuous improvement
Support defining, monitoring and the continuous improvement of R&D Quality KPI/metrics in the GLP/GCP/GVP area
Support key GLP/GCP/GVP process/system improvements in collaboration with R&D functions, R&D Quality peers, and other Quality colleagues
As part of R&D Quality Excellence Team, support the continuous improvement of R&D Annual Quality Plan, R&D Quality Management Review, and other quality governance mechanisms.
Work with cross functional stakeholders and responsible for driving establishing R&D Quality impacting processes and infrastructure that are efficient, scalable and robust to support R&D QMS performance in a global environment.
Work with cross functional stakeholders on improving current R&D Quality impacting processes, eliminating redundancies, improving knowledge management and integration to increase productivity, transparency and quality.
Support contributing knowledge, performing analysis, developing solutions, assisting with project implementation, providing training, and measuring results, for continuous improvement initiatives.
Support the R&D Quality Leadership Team and Quality Scaled and Digital Services team, along with other stakeholders, to continuously improve the R&D Quality Management Review with the aim to heighten management awareness and oversight of the R&D (GLP/GCP/GVP) QMS performance. This includes but not limited to
Portfolio quality health dashboard
Inspection and audit performance dashboard
Quality systems performance dashboard
Key R&D processes quality health dashboard
Key R&D quality risks
Key R&D Annual Quality Plan focus areas update
Support the R&D Quality Leadership Team in creating the annual strategic quality plan based on current risks and priorities, and periodically evaluate and escalate top risks with in R&D QMS.
Proactively work across Quality and with R&D business process owners to drive the continuous improvement of key GLP/GCP/GVP processes. Support R&D Quality SMEs in continous improvement activities.
Develop or review relevant GxP SOPs governing Quality activities as well as other functional area activities to identify areas for improvement and gaps.
Assure appropriate escalations and notification to exeutive level management is occurring for all R&D quality issues.
Support the R&D Quality Leaderhsip team in collaboration with R&D, to identify, evaluate, and drive the remediation of fundamental quality risks and issues within R&D.
Collaborate with R&D Quality colleages, Quality Scaled and Digital Services Team and R&D to identify and execute innovative GLP/GCP/GVP training needs, learnings and other approaches to continue to drive Quality Culture in R&D.
8 or more years experience in quality assurance and continuous improvement in both tactical and strategic capacities.
Comprehensive knowledge of global regulations and GCP/GLP/GVP.
Capability to drive continuous improvement in a matrixed organization with multiple stakeholders.
Business Analytics tool experience (Qlik, Tableau, etc)
- Bachelor’s degree in life science required. Advanced degree strongly preferred.
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.