Senior Associate, Quality Assurance at Insmed Incorporated

Saxnäs, , Sweden -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

0.0

Posted On

13 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Complaint Handling, GQP, GMP, Quality Management Systems, Root Cause Analysis, CAPA, Regulatory Compliance, Technical Writing, Microsoft Office, Internal Auditing, Supplier Auditing, Adverse Event Reporting, Documentation Practice, Cross-functional Collaboration, Communication Skills, Detail Orientation

Industry

Biotechnology Research

Description

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 Role: Job Description Summary This 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 Do: Ensure 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 returns. Perform complaint investigations to determine root cause, identify resolution and respond to the complainants. Issue 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. Support 3 officer activities and authority inspection Actively work on Global and local Quality projects Who You Are: Minimum 3 years’ experience in a similar role within pharmaceutical or medical device industry Thorough knowledge of GMP, GQP and good documentation practice Experience in quality related complaint handling is preferred Experience in working with an electronic Quality Management system 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 player. Must have excellent communication skills (verbal and written). Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). An uncompromising ethical standard and level of conduct are essential Bachelor’s degree in life sciences or equivalent through experience Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect and Integrity; along with any other position specific competencies. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace Non-smoker Where You’ll Work This role is based out of our Tokyo office with weekly flexibility to support both your professional and personal needs. Travel Requirements This role requires occasional domestic/international travel (approximately 10%) Life 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. Insmed is a people-first global biopharmaceutical company driven to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, NJ, with locations across the U.S., EMEA, and Japan, we’re guided by our core values and a shared commitment to patients and each other. We’ve been named Science’s No. 1 Top Employer four years in a row, certified as a Great Place to Work in the U.S., and recognized among The Sunday Times’ and BioSpace’s Best Places to Work. For patients, each other, and the future of science, we’re in. Are you? Wherever you are in the world or in your career, we want to stay connected. Sign up for our talent community to hear about new career opportunities, company news, and how our teams around the world are striving to make a difference for patients every day. Sign UP

Responsibilities

Manage GQP/QMS operations for Japan marketed products, focusing on the end-to-end handling of medicinal and medical device product complaints. Support product changes, deviations, CAPAs, and assist with internal and external quality audits.