Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

 

	Consistently Ranked Science’s Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

 

This position is in charge of GQP/QMS operations for Japan marketed products, which handle Product Complaints from initiation to close-out, both for drug product and medical device, full documentation to support Japan market release, documentation of changes, deviations & CAPAs as needed to support products in Japan.

Responsibilities will include, but are not limited to, the following:
• 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.rics.
• Actively work on Global and local Quality projects
• Reporting of any Quality related issues to Quality Assurance Officer (Hinseki), and other management as appropriate.Experience/Knowledge/Skills
• 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 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 player
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• An uncompromising ethical standard and level of conduct are essentialQualification/Certificate
• Bachelor’s degree in life sciences or equivalent through experienceOthers
• 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
• Travel up to 10% (domestic and international), some of which will be overnight in nature

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

 

For more information on U.S. benefits click here.

 

 

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, 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.