Senior Associate, Quality Assurance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we’re in. Are you?About The RoleThis position is in charge of GQP/QMS operations for Japan marketed products, which handle Product Complaints from initiation to close-out, both for medicinal product and medical device, full documentation to support Japan market release, documentation of changes, deviations & CAPAs as needed to support products in Japan.What You'll DoEnsure accurate and thorough complaint intake information, replacement need, troubleshooting with complainant, complainant follow-ups, product complaint investigations, tracking and trending of complaint data. Accurate reporting into the internal software system/QMS system, follow-up, communication to complainants, identification of trends, assisting with determining CAPA’s Review each complaint assigned for accurate/missing information, complaint details, further regulatory compliance actions, replacement needs, or unreported adverse events. Act as technical product subject matter expert and trouble shoot complaints with complainants Contact complainants for complaint follow up information, trouble shooting, and medical device replacement and returnsPerform complaint investigations to determine root cause, identify resolution and respond to the complainantsIssue complaint close-out notifications to complainants. Ensure Adverse Events reported through the complaint system or at patient follow-up are reported within one business day Ensure the reconciliation between the complaints report and Safety/Customer reports Support product/supplier changes, deviations and CAPAs, assisting with technical write up, impact assessment, and root cause analysis.Assist in maintaining the applicable GQP and QMS SOPs.Check quality progress on a monthly basis as they relate to batch release, complaints, deviations, CAPAs’, change requests or other relevant quality metrics.Asist internal process audits and external supplier audits as necessary.Actively work on Global and local Quality projects Support 3 officer activities and authority inspectionWho You AreExperience/Knowledge/Skills Minimum 3 years’ experience in a similar role within pharmaceutical or medical device industryThorough knowledge of GMP, GQP and good documentation practiceExperience in quality related complaint handling is preferredExperience in working with an electronic Quality Management system is desired.Must have excellent communication skills (verbal and written).Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.Highly organized with a strong attention to detail, clarity, accuracy and conciseness.Works effectively across functions as a team playerHighly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).An uncompromising ethical standard and level of conduct are essentialQualification/CertificateBachelor’s degree in life sciences or equivalent through experienceOthersMust successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect and Integrity; along with any other position specific competenciesIndividuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplaceNon-smokerTravel up to 10% (domestic and international), some of which will be overnight in natureLife at Insmedインスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイルに対応したフリーアドレス制を導入し、開放的で柔軟な働き方を実現しています。カフェエリアでは部門を超えた自由なコミュニケーションやコラボレーションを促進する空間を創り出しています。日本法人の拠点として、患者さんにより良い医療をお届けするため、社員一同が一丸となって日々邁進しています。社員一人一人の充実した働き方を実現するためのサポート： ワークライフバランスの実現フレキシブルな勤務時間や充実した休暇制度 魅力的な報酬制度退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会 キャリア開発支援社内研修、外部研修プログラムの活用、LinkedIn Learning、業務に特化した専門研修 先進的な学習支援AI搭載の学習ツール、社内リソースへのアクセスを支援するデジタルアシスタント グローバルの表彰制度や従業員リソースグループ活動 ハイブリッドワーク環境の整備場所や時差を超えたシームレスな協働を実現する最新テクノロジー、充実したIT支援体制Current Insmed Employees: Please apply via the Jobs Hub in Workday.Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.Applications are accepted for 5 calendar days from the date posted or until the position is filled.