Insmed Incorporated

Senior Associate, Quality Assurance

Job Post Information* : Posted Date 3 months ago(2/13/2024 7:37 PM)
External ID
2024-5497
Number of Positions
1
Remote
No
Position Location (WD) : Location
JP-JPN-13-Tokyo

Company Description

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.

Recognitions

 

Top-Employer-2023-Colors-221x300

Named Science’s Top Employer in 2021, 2022, and 2023

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 were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row.

  

 

Insmed_2023_Certification_Badge2

 

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

  

 

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.

Responsibilities

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.
  • Actively work on Global and local Quality projects
  • Support 3 officer activities and authority inspection
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 essential
Qualification/Certificate
  • Bachelor’s degree in life sciences or equivalent through experience
Others
  • 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

Qualifications

  • Bachelor’s degree in life sciences or equivalent through experience
  • Native Japanese Speaker
  • 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

Compensation & Benefits

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

  • Flexible approach to where and how we work, regionally based
  • Competitive compensation package including bonus 
  • Stock options and RSU awards
  • Employee Stock Purchase Plan (ESPP)
  • Flexible Vacation Policy
  • Generous paid holiday schedule and winter break 

ADDITIONAL U.S. BENEFITS:

  • 401(k) plan with company match
  • Medical, dental, and vision plans
  • Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
  • Company-provided short and long-term disability benefits
  • Unique offerings of pet, legal, and supplemental life insurance
  • Flexible spending accounts for medical and dependent care
  • Accident and Hospital Indemnity insurance
  • Employee Assistance Program (EAP)
  • Mental Health on-line digital resource
  • Well-being reimbursement
  • Paid leave benefits for new parents
  • Paid time off to volunteer
  • On-site, no-cost fitness center at our U.S. headquarters

Additional Information

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.

 

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

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