Quality Lead at Alexion for medical devices, including the device constituent part of combination products. This position will interact with internal cross functional teams working with all levels of colleagues in the Alexion organization. Activities will include Quality strategy for the development, documenting, and maintenance of data, policies, procedures, and systems to ensure compliance with Medical Device (ISO 13485, 21CFR Part 820, MEDDEV 2.12-1) and Combination Product regulations (21CFR part 4).
The primary purpose of this position is to provide Device Quality Leadership to ensure successful quality oversight of current and prospective device and combination product portfolio. This individual will be expected to apply his/her knowledge of product development, design control principles, risk management and quality engineering techniques to positively influence commercial and new product launches to ensure they are developed and manufactured in accordance with regulatory, company, and patient requirements.
+ Lead the development of a Quality System gap assessment and mitigation against the requirements of applicable medical device and combination product regulatory standards.
+ Responsible for maintaining and directing a compliant Quality System for medical devices.
+ Develop an efficient, fit for purpose and effective Quality Management System that meets global device requirements, including CAPA, Complaint Management, Document Control, Change Control, Internal Auditing, Risk Management, and Supplier Management.
+ Provide guidance to all personnel to ensure end-to-end Quality by Design, Six Sigma, Reliability, and Design Control principles are implemented effectively.
+ Support the integration of the specific medical device quality system requirements with the current pharmaceutical quality system.
+ Support development of submissions with global regulatory agencies leading to approvals and market launches of the drug delivery device
+ Lead Quality in the preparation and submission of applications and routine registrations, reports and renewals as required.
+ Partner with Quality Compliance, Site Quality Teams, Quality Systems and R&D Quality to develop a roadmap for sustained, successful Regulatory Inspection performance throughout the lifecycle of the product and device combination.
+ Build and manage the quality relationship with development partners, vendors/suppliers, consultants, and external product development resources.
+ Periodically audit our operations and those of our vendors.
Experience and Education
+ Degree in engineering, physical, or life science.
+ 10+ years quality management / regulatory leadership experience in medical devices, experience in pharmaceuticals and combination products is highly desirable.
+ Experience in successful development, filing and gaining approval for global regulatory submissions
+ Experience in software driven medical devices / capital equipment. Extensive knowledge of FDA, GMP and ISO standards and regulations.
+ Combination product and device delivery system experience
+ Demonstrated ability in decision making, problem solving and project management.
+ Collaborate, negotiate, influence and lead in a matrix organization
+ Excellent communication and interpersonal skills
+ Proven record in demonstrating agility
+ Flexibility to travel in support of the role
+ Knowledge of process development and quality systems with a strong business and technical acumen would be an advantage.
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.