Alexion Pharmaceuticals Director, Enterprise Quality System, Regulatory Compliance & Intelligence in Boston, Massachusetts
Position Summary & Scope
The Director, Regulatory Compliance & Intelligence has a global focus within the Enterprise Quality Systems and overall Quality Organization, and provides leadership and support to the continuous improvement of the organization and company.
The Director will be very active in the leadership, design, implementation, maintenance, and execution of the following key processes: notification/escalation to senior management, regulatory reporting (BPDR, MDR, EU Defective Product), regulatory intelligence, and product recall; and will play a key role in Deviation/CAPA and Complaints processes.
Establish the Enterprise Regulatory Compliance Function, including:
Refine and update processes for Quality Issue Escalation/Notification to Management; Quality Management Review; Recall; Field Action; and Regulatory Health Authority Reporting
Establish IT strategy and specify tools and transactions supporting above processes
Serve as Enterprise Business Process Owner for above processes
Establish the data flow process and tools for the Enterprise Regulatory Intelligence function, including:
Source identification and collection mechanisms
Analytics process, accountabilities, and tools
Action planning and communications
Inspection, audit, and submission support functions
Develop business case for organizational or IT enhancements as applicable
As Enterprise Business Process Owner for the above-noted processes:
Manage the relevant compliance information flow to the highest levels, both internally and externally (applicable agencies)
Analyze and communicate (to all levels) emerging global and strategic regulatory compliance and intelligence initiatives and trends that impact or influence the company’s quality systems, quality, regulatory, and compliance practices and policies
Drive consistent reporting of appropriate quality system and other applicable metrics.
Provide leadership support to audits and inspections (including readiness), as appropriate.
Minimum of 10-15+ years of experience in pharmaceuticals/ biopharmaceuticals / biotech and/or related industries with a concentration in one of more of the following functions: Quality, Quality Systems, Regulatory, Regulatory Compliance & Intelligence, Inspection Preparation, Root Cause analysis and Risk Assessment.
In depth knowledge of global GxP regulations
Strong knowledge of good regulatory compliance and intelligence practices, policies, procedures
Strong knowledge of good quality practices, policies, procedures
Experience effectively communicating quality, regulatory, compliance and/or intelligence issues of various magnitude and impact to appropriate internal and external stakeholders
Global experience across multi-sites is preferred in regulatory compliance, intelligence, quality systems (or other areas of quality)
A strong customer focus and ability to prioritize and adapt to business needs are required
Demonstrated project management skills; experience leading and participating on cross-functional teams.
Strong business partner with a focus on collaborating and delivering results.
Knowledge of applicable international GXP regulations and standards
Experience communicating/presenting to various levels of senior management (internally and external agencies)
Good ability to analyze systems and data, and make sound recommendations as a result
Extensive knowledge of investigation techniques and tools
Extensive knowledge of risk assessment strategies and tools
Good knowledge of relevant IT strategies / tools, particularly as relates to Quality, Regulatory Compliance, and Intelligence
Ability to identify and mitigate risks
Excellent written and verbal communication skills
Experience leading and/or collaborating with high performance teams, cross functional projects
- Bachelor’s degree in Scientific or engineering discipline required. Advanced scientific, technical, or business degree a plus.
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 the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). 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 two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. 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.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. 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.