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?<div><div><div><div><div><div><div>About the Role:</div></div></div></div></div></div></div>Responsible for quality and regulatory compliance related to GMP/GQP/QMS, Pharmaceuticals and Devices. Will ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines. The successful candidate will be a highly motivated individual to supervise the local Quality Assurance and Control Activities for release of commercial product in Japan, and will be responsible for the day-to-day Quality Control of the Japanese operations.<div><div><div><div><div><div><div>What You'll Do:</div></div></div></div></div></div></div><ul><li>Act as Quality Assurance Officer (Hinseki) and lead GQP/QMS activities</li><li>Conduct or supervision of quality assurance activities, including but not limited to, product release, self-inspection, training, handling of defects, quality complaint and change control.</li><li>Document Control and management for GQP/QMS/GDP</li><li>Introduction and maintenance of Quality Systems including CSV and ER/ES within Veeva Quality and QMS</li><li>Product market release in Japan</li><li>Corrective Action and Preventive Action</li><li>Conduct internal process audits and external supplier audits as necessary</li><li>Communication and negotiation with External Suppliers and internal stakeholders</li><li>Creation and Maintenance of Quality Agreements for Japan Suppliers</li><li>Collaboration with Drug Safety pharmacovigilance</li><li>Product Artwork review and approval</li><li>Others quality assurance related tasks as Quality Assurance Officer (Hinseki)</li><li>Reporting of any Quality related issue to the Marketing Supervisor General (Sokatsu)</li><li>Communication with Global QA and External Suppliers</li><li>Ensure the consistency between JNDA dossiers and actual operating process</li><li>Manage Quality and Regulatory compliance tasks of the GMP inspections and FMA registration</li><li>Correspondence with MHLW, PMDA and Tokyo Metropolitan office</li><li>Lead and manage the GQP team, providing guidance and support as their people manager</li></ul>Who You Are:<ul><li>At least 5 years of QA experience in regulated industry such as pharmaceutical,biologics or device.</li><li>Knowledge of ICH and GMP/GQP/QMS regulation</li><li>Understanding of PMDA inspection and License inspection procedures</li><li>Demonstrated understanding of the science underlying relevant diseases and its impact on the Quality process.</li><li>Strong understanding of the drug development process.</li><li>Demonstrated understanding of legal, regulatory and compliance policies</li><li>Experience with effectively managing PMDA inspections, working with regulators, and external supplier audits.</li><li>Must have good communication and presentation skills (verbal and written / Japanese and English)</li><li>Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.</li><li>Good problem solving skills including root cause analysis approaches</li><li>Demonstrated knowledge with the following regulations and guidance:<ul><li>ICH Q10 – Pharmaceutical Quality Systems</li><li>Japanese GMP for Drugs</li><li>Basic knowledge of Japanese device regulations</li></ul></li><li>Ability to make risk-based decisions based on current laws, regulations and experience</li><li>Highly organized with a strong attention to detail, clarity, accuracy and conciseness.</li><li>Demonstrated experience improving, developing and implementing new processes</li><li>Works effectively across functions and global environment as a team player</li><li>Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).</li><li>An uncompromising ethical standard and level of conduct are essential.</li><li>Bachelor’s degree (scientific or clinical background desirable) required; advanced degree preferred</li><li>Pharmacist is a plus</li><li>Experience as Hinseki (Quality Assurance Officer) in Pharma is a plus</li><li>Must 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 workplace</li><li>Non-smoker</li><li>Travel up to 30% (domestic and international), some of which will be overnight in nature</li></ul> 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 <a target="_blank" href="mailto:TotalRewards@insmed.com">TotalRewards@insmed.com</a> 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.

Director/Associate Director, Quality Assurance

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Insmed

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