Alexion Pharmaceuticals Senior Director, Pharmacovigilance, GMA and GRA Quality Operations in Boston, Massachusetts
This senior leader will lead a team of Quality experts to:
Be accountable for the development and implementation of a global strategy to plan, control and improve quality for all aspects of global good pharmacovigilance (GVP) activities. Will serve as the lead for Global Pharmacovigilance compliance with global regulations for clinical and commercial pharmacovigilance for multiple products.
Influence Global Drug Safety (GDS), Global Medical Affairs(GMA), Global Regulatory Affairs (GRA) senior executives to successfully embed a strong governance model, including a dashboard of KQPls to oversee the performance of the applicable QMS
Identify risks, evaluate risks and drive the mitigation of risks as well as CAPA for systematic issues to drive equality, in collaboration with business partners. in our development programs.
This leader will lead a team of quality experts for the following principle responsibilities:
In partnership with the GDS, GMA and GRA leadership teams, create an annual strategic quality management plan based on current risks that will govern and oversee the implementation of the applicable QMS.
Collaborate with Executive level leadership and respective teams, including Corporate Quality/GxP Audit, GDS, GMA, GRA, Affiliate Quality to ensure we develop robust CAPAs in response to identified global GVP quality issues and observations.
Quality Operations Lead for global GVP-related quality issue investigations and CAPA management process.
Lead investigations with issue owners and perform root causes analyses
Perform risk assessments on issues and audit findings to determine the need for CAPAs
Review and approve CAPAs
Monitor CAPA metrics and report quarterly to Senior level quality leadership and executive management
Provide periodic CAPA updates to the PSMF
Accountable for the strategy and execution of GVP inspection readiness for Alexion, including SME training/preparation and back room activities, and manage GVP inspections as Quality Lead. Analyze the risks, propose the strategy for readiness and manage the implementation of the inspection readiness program.
Collect and monitor compliance metrics globally and evaluate possible trends and partner with GDS, GMA and GRA to develop global CAPAs as needed. Identify key GxP risks in GDS/GMA/GRA and support the implementation of GxP risk mitigation plans where appropriate. Support development of risk-based audit strategies in partnership with GxP Audit.
Review and serve as Quality Approver for GDS, GMA, GRA related GxP SOPs
Coordinate quality inputs for PSMF and partner with GDS team and other quality units to support maintenance and compliance of PSMF on an ongoing basis.
Participate as GVP Quality Representative in Quality Council, Global Safety Committee as well as other key Quality and cross-functional committees/teams to ensure continuous alignment and proactive approach to GVP compliance
Consult with GRA, GMA and GDS and other stakeholders to ensure GVP compliance.
Develop or review relevant GxP SOPs governing Quality activities as well as other functional area activities
Collaborate with executive leadership to implement GVP training and Corporate Quality/GxP training to support the development and implementation of effective GDS, GMA, GRA compliance training
Provide oversight for all quality issue management including audit reports, quality issues/incidents, and CAPA development within scope. Ensure timely implementation and closure of CAPAs. Metrics will be developed to aid in the oversight and communication.
Assure appropriate escalations and notification to executive level management is occurring for all GxP-related issues within scope.
Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation. Provide expertise and recommendations. Ensure timely review and closure of quality issues.
Conduct research and provide guidance, interpretation, support, training and key input on interpretation of GVP regulations, guidelines, corporate standards and policies
Serve as an external expert in the industry related to management of GVP quality systems
15 or more years experience in pharmacovigilance 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 reviewing and/or providing input for the PSMF
Significant experience in leading GVP regulatory inspections
Strong people management experience in developing team
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
Strong experience working in a matrixed environment.
- 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 through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), 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). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. 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, and metabolic disorders. Alexion has been named to the Forbes' list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also 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.