Specialist, QA DS Manufacturing - Ireland
Specialist, Quality Assurance
Manager, Quality Assurance DS
Last Revised (Date):
May 17th, 2017
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. Alexion is also establishing a premier global metabolic rare disease franchise, which includes Kanuma™ (sebelipase alfa) for patients with lysosomal acid lipase deficiency (LAL-D), and Strensiq™ (asfotase alfa) for patients with hypophosphatasia (HPP). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas. As the global leader in complement inhibition, the Company is strengthening and broadening its portfolio of complement inhibitors across diverse platforms, including evaluating potential indications for Soliris in additional severe and ultra-rare disorders. Further information about Alexion can be found at: www.alexion.com. Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH, and in the United States, European Union, Japan and other countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. Further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
The Specialist for QA Drug Substance Manufacturing will be responsible, with management support, for providing oversight of quality activities associated with drug substance manufacturing processes to contract manufacturing organizations. The Specialist contributes and guides completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA's. Acts independently to determine methods and procedures on new assignments and provides guidance to lower-level personnel. Performs all responsibilities in accordance with company policies, procedures, and regulations.
- Serve as Quality Assurance SME for Drug Substance manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug substance manufacturing, storage and shipping activities are compliant
- Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance
- Provides oversight to continuous quality system improvements and supports implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact Alexion
- Works closely to build relationships with contract manufacturers quality personnel
- Works closely with internal cross-functional impacted areas, such as CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events
- Responsible for reviewing contractor documents to ensure that they comply with Alexion procedures and meet Alexion standards
- Approve Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organisations
- Support contract manufacturing organisation audits, including pre-approval inspections, as necessary
- Develop and issue quality metrics pertaining to the process quality activities
- Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
- Review and approves Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
- Represents Quality Assurance to guide various projects and technical meetings, as needed
- Responsible for documenting and reporting compliance issues to management
- Must have experience/knowledge of drug substance manufacturing processes in a cGMP environment
- Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance manufacturing. Minimum of 2-5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry
- Experience working with contract manufacturing organisations
- Ability to provide project leadership and guide successful completion of Quality projects
- Excellent written and verbal communication and negotiating skills
- Risk assessment and risk management
- Ability to exercise judgment with defined procedures and practices to determine appropriate action
- Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
- Ability to monitor and report on assigned tasks, goals, and objectives.
Note: This role requires 20% travel
- Bachelor’s degree required; preference given to candidates with advanced degrees; Two or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.
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. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.