Bridgewater Township, New Jersey

Company Description

About Insmed:

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.
Overview

About the Role
  • Oversee processes within the QMS including Change Control, Deviations, and CAPA. This includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations for the specified QMS processes.
  • Complaint Investigations/Trending, Deviation/CAPA/EC monitoring coordination and completion.
  • Performs QA review and approval of deviations, CAPAs, and change controls. Ensures completeness, accuracy, and compliance to all applicable cGMP regulations.
  • Reviews and evaluates corrective/preventive actions (CAPA) including the CAPA effectiveness program. Responsible for communicating CAPA status to cross-functional departments and external partners.
  • Leads the investigation of complex deviations, and product complaints. Ensures thorough investigations are conducted using various root cause analysis techniques and that all investigations are technically sound/properly documented, with corrective actions for prevention of reoccurrence identified.
  • Tracking and identifying trends of quality events, including but not limited to complaints.
  • Handles compilation of quality metrics for monthly trending, management review meetings and follow up for the closure of process improvements. Presentation and communication of trending reports in respective Quality forums.
  • Training of QA and stakeholders in QMS processes.
  • Reviews and updates SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements.
  • Identifies and implements process improvement projects to drive success in the areas of Quality Management Systems.
  • Assists in inspection readiness activities and plays a key role during inspections/audits.
  • Provided support during internal review, Audits, FDA Audits and Third-party consultant Audits.

Vaccine Mandate: Subject to applicable law, Insmed requires that all U.S. employees and new hires are fully vaccinated (meaning that it has been 2 weeks post 2nd dose for Pfizer/Moderna or 2 weeks post 1st dose for Johnson & Johnson) against COVID-19.
Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:
  • Oversee processes within the QMS including Change Control, Deviations, and CAPA. This includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations for the specified QMS processes.
  • Complaint Investigations/Trending, Deviation/CAPA/EC monitoring coordination and completion.
  • Performs QA review and approval of deviations, CAPAs, and change controls. Ensures completeness, accuracy, and compliance to all applicable cGMP regulations.
  • Reviews and evaluates corrective/preventive actions (CAPA) including the CAPA effectiveness program. Responsible for communicating CAPA status to cross-functional departments and external partners.
  • Leads the investigation of complex deviations, and product complaints. Ensures thorough investigations are conducted using various root cause analysis techniques and that all investigations are technically sound/properly documented, with corrective actions for prevention of reoccurrence identified.
  • Tracking and identifying trends of quality events, including but not limited to complaints.
  • Handles compilation of quality metrics for monthly trending, management review meetings and follow up for the closure of process improvements. Presentation and communication of trending reports in respective Quality forums.
  • Training of QA and stakeholders in QMS processes.
  • Reviews and updates SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements.
  • Identifies and implements process improvement projects to drive success in the areas of Quality Management Systems.
  • Assists in inspection readiness activities and plays a key role during inspections/audits
  • Provided support during internal review, Audits, FDA Audits and Third-party consultant Audits.
Qualifications

About You:

  • BS degree in Chemistry, Life Science or related discipline required.
  • A minimum of 5 years of relevant Quality Assurance experience required. An advanced degree (MS) and a minimum of 3 years relevant experience will also be considered.
  • Direct experience with Change Control, Deviations/CAPAs, and Complaints in pharmaceutical or medical device products.
  • Full understanding of cGMPs for pharmaceutical products.
  • Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
  • Experience at reviewing manufacturing investigations, lab investigations, and change controls.
  • Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals and/or ISO 14971
  • Demonstrate ability to manage projects and variable workloads.
  • Must have excellent communication skills (verbal and written).
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
  • Proficient in analyzing data trends in Excel or Minitab. Preferred ASQ CQE certification.
Travel Requirements

Up to 30% travel, both domestic and/or international.
Additional Information

This role is to be filled outside Colorado.

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.

If you need a reasonable accommodation for any part of the employment 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.

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.

Please note that we review every submission, and we will keep all submissions on file for six months.

Bridgewater Township, New Jersey

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. The Company is dedicated to developing and bringing to market therapies that make a real difference in patients’ lives, while striving to understand and enhance the entire patient experience, from diagnosis and treatment to everyday living. Headquartered in Bridgewater, NJ, we are a rapidly growing company with offices in seven countries

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