Associate Director, Clinical Quality Assurance at Insmed Incorporated

Saxnäs, , Sweden -

Full Time

Start Date

Immediate

Expiry Date

21 Jul, 26

Salary

0.0

Posted On

22 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Quality Assurance, GCP, Regulatory compliance, Audit management, Risk-based quality systems, SOP development, Regulatory inspections, Vendor management, CAPA tracking, ICH E6, Clinical development, Quality documentation, Team leadership, Cross-functional collaboration, Data analysis, Strategic planning

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: Reporting to the Director of Clinical Quality Assurance, the Associate Director of Clinical Quality Assurance (CQA) - Japan & APAC serves as a CQA lead representative on the development team assuring quality and regulatory compliance related to GCPs and other related activities performed by Medical/Clinical Departments in Japan and Asia-Pacific (APAC) region. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines. What You'll Do: Japan & APAC GCP Subject Matter Expert (SME). Contribute to and support the maintenance of a risk-based and scientific-based quality system to support GCP. Ensure that a strategic audit plan is implemented. That the activities are conducted and reported according to SOPs and regulations. Perform audits of investigator sites, vendors, and internal systems/processes. Support the evaluation and acceptability of vendors for potential use and provide direction, guidance and strategy for company Quality and Compliance. Support strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues. Establish and foster compliance with ICH E6 Guideline for Good Clinical Practice. Provide support and coaching to other staff members to develop additional quality and auditing resources. Manage regional quality documentation in Veeva QMS and Vault. Act as company’s representative during regulatory agency inspections. Who You Are: Minimum BS degree in Biology or Chemistry or related life sciences discipline required with minimum 7-10 years of experience. Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered. Experience in effectively managing regulatory agency inspections and working with regulators and internal staff to help prepare for inspections is required. An understanding of regulations, development processes and regulatory inspection procedures is required. Experience developing SOPs, reviewing internal clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs is essential. GCP audit experience is required including ability to conduct external audits of investigator sites, CROs, supporting laboratories, and monitoring organizations with responsibility for writing audit reports and reviewing and tracking CAPAs. Ability to conduct external audits of investigator sites, CROs, supporting laboratories, and monitoring organizations with responsibility for writing audit reports and reviewing and tracking CAPAs. Must demonstrate practical working knowledge of GCP regulations. Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice. Requires solid experience with Phases I-IV (particularly Phase III); experience with Regulatory approval, NDAs and MAAs is preferred. Must be able to foster a collaborative/partnership environment, adapt to other personalities in a respectful manner that is conducive to goal achievement and team building while maintaining quality and compliance. Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. Must exhibit Insmed’s five (5) core values of: Respect, Passion, Integrity, Collaboration and Accountability. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace. Non-Smoker Ability to travel both domestic and internationally, approximately 25%-30% 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

The Associate Director of Clinical Quality Assurance serves as the lead representative for Japan and APAC, ensuring GCP compliance and regulatory adherence for clinical activities. They are responsible for implementing strategic audit plans, managing quality documentation, and acting as the company representative during regulatory inspections.