* This position can be based from any of the following Alexion locations; San Francisco, CA, Boston, MA, New Haven, CT, or Blue Bell, PA, and may require up to 20% travel.
Quality Key Point of Contact for major processes/platforms such as TMF, CRO oversight, medical device. Drive the excellence of major processes/platforms in Research & Clinical Development Quality Operations team working with R&D owners of these processes. Provide Quality Operations guidance to other Quality Operations Leads and Clinical Development teams utilizing these processes/platforms. Be accountable for the development and implementation of a global strategy to plan, control, and improve quality for assigned programs including several pivotal/registry studies in the Clinical Development portfolio, partnering with peers to assure quality coverage of respective studies, influencing Clinical Development stakeholders to successfully embed a strong Quality culture. Identify, evaluate, and drive the remediation of fundamental risks and quality issues within Clinical Development program(s) to drive quality, in collaboration with Clinical Development, in Alexion’s portfolio. Drive inspection readiness for GCP inspections in assigned portfolio, partnering with the Director, Inspection Management, to assure successful outcomes during submission-related and unannounced inspections. Provide mentoring to Quality Operations Leads, assuring program alignment and team engagement.
- In alignment with Sr. Director Clinical Development Quality Operations, develops an overarching strategy related to proactive and sustainable quality and compliance for programs/portfolio across assigned therapeutic area(s)
- Where applicable, represent Quality R&D on Alexion Global Program Teams (GPTs)
- Lead a team of 3-5 R&D Quality Operations Leads assuring portfolio clinical quality oversight and management across assigned therapeutic area(s)
- Provide guidance to assigned R&D Quality Operations Leads or serve as the quality expert for global/systemic clinical quality issue investigations, which includes:
- In collaboration with operational issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis
- Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAs
- Reviews and approves Deviations and CAPAs
- As appropriate escalate issues of critical noncompliance and/or lack of urgency in remediation to Quality R&D and appropriate operational Leadership
- Where applicable provide appropriate quality metrics for established Quality Management Reviews (Global Quality, R&D etc.).
- Be accountable for leading inspection readiness for assigned programs/portfolio including but not limited to:
- Provide leadership and guidance to assigned R&D Quality Operations Leads in promoting a culture of inspection readiness and sustainable clinical compliance
- Provide guidance to R&D Quality Operations Leads in Inspection Readiness and Preparation Activities (e.g. SME training, Mock inspection etc.)
- Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic Area
- Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable e.g. TMF health oversight, CRO/Vendor oversight, medical device requirements etc.
- Lead and support risk-based quality management (RBQM) for the planning and execution of clinical protocols, assuring an ongoing cycle for Plan – Do – Check – Act.
- In collaboration with R&D, identify, evaluate, and drive the remediation of fundamental risks and issues (RBQM) within R&D to drive quality across assigned GPTs
- Provide guidance or collaboratively works with Head, R&D Audit Operations to ensure a robust clinical audit strategy.
- May serve in an advisory/ consultative role in development of audit strategy for clinical programs, process and vendor audits
- In collaboration and coordination with other R&D functions (e.g. DOQS, other R&D functions and R&D OP-Ex Lead) develop appropriate vendor quality oversight plans and processes
- Lead development and or provide guidance to R&D Quality Operations Leads in review of Clinical Trial Document Templates, study related documents, SOPs, Policies, etc., as needed.
- Actively participate in meetings driving quality and business performance
- Represent Quality R&D in Due Diligence and integration activities as assigned
- Develop, lead and support Enterprise level initiatives
- Represent Quality R&D in leading/supporting Diversity, Inclusion & Belonging
- 10 or more years experience in GCP and quality assurance in both tactical and strategic capacities
- Established expertise and training in GxP systems. Extensive knowledge of global regulations and standards.
- Significant experience with GxP investigations, risk assessments and CAPA management
- Experience participating in regulatory inspections
- Functional planning experience and ability to develop functional vision, priorities and tactics
- Experience with multinational products and regulations as well as with mandated risk management plans
- Experience in managing, mentoring and directing people
- 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.
Location: Boston, MA, US
Posted Date: 4/20/2021