Assoc. Director, Computer System Validation Operational Lead
Insmed Incorporated

Bridgewater, New Jersey

Posted in Science and Research


This job has expired.

Job Info


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

Named Science's Top Employer in 2021 and 2022

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.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work-certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in Biopharma TM List, Small and Medium, and one of the Best Workplaces in New York TM , which recognizes companies headquartered in NY, NJ, and CT.

Overview

Provide strategic oversight to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (e.g. SDLC, IT Change Control) per associated regulatory and security requirements.

This role oversees vendors and / or contractors.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

  • Manage day-to-day operations of the GxP function within IT.
  • Coordinate all validation activities with outsourced validation vendor.
  • Act as primary point of contact for IT during internal and external inspections and provide responses to observations.
  • Think critically and guide others to think critically to assess system risk to patient safety and product quality.
  • Serve as a Computer System Validation Subject Matter Expert and provide strategic and consistent guidance.
  • Oversee and lead the development of Computer System Validation (CSV) and operational strategies by establishing or updating governing policies and procedures aligned to FDA and EU Guidance in collaboration with Quality Assurance.
  • Ensure company's GxP computerized IT systems are tested, validated and controlled to comply with applicable regulations and internal SOPs and policies in collaboration with Quality Assurance.
  • Support audits of IT systems to ensure software and services are in a state of control and Insmed can leverage such audits and vendor documentation to reduce delivery efforts internally.
  • Manage the development of system specific validation plans and strategy using a risk-based approach aligned with computer software assurance methodologies in collaboration with Quality Assurance
  • Author and revise validation documents such as SOPs, protocols, and work instructions as necessary.
  • Assess and provide estimates to determine validation work effort and estimate the necessary time-to-completion.
  • In collaboration with Quality Assurance, ensure completed validation and qualification documents are maintained and well-organized in Veeva QualityDocs to easily and quickly retrieved for inspections.
  • Anticipate, budget, and execute all CSV support for new projects, enhancements, and ongoing changes to production.
  • Closely work with the IT Applications, IT Infrastructure, IT Security, and Quality Assurance on various projects.
  • Train, coach, and mentor GxP system owners.
  • Cultivate and disseminate knowledge of quality assurance best practices as needed.


Qualifications

  • Bachelor's Degree in Computer Science
  • 5+ years' experience in a management validation role with responsibility for computer systems specifically QMS, LIMS, CTMS, and other Clinical/Manufacturing systems.
  • 5+ years' experience with Veeva QualityDocs /QMS
  • 5+ years' experience developing and managing projects budgets and forecasts.
  • Demonstrated knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs).
  • Demonstrated knowledge and expertise in CSV related regulatory requirements (e.g. FDA, 21 CFR, Annex 11).
  • Knowledgeable of EU and FDA regulations regarding the Validation Life Cycle and the Software Development Life Cycle.
  • Knowledge and understanding of the GAMP 5 2nd Edition.
  • Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.
  • Understanding of document management principals.
  • Experience providing oversite to Cloud and GxP computer systems validation activities.
  • Experience validating GxP applications, IT infrastructure, and cloud-based systems.
  • Experience managing oversite of multiple enterprise projects and processes at one time.
  • Strong customer service skills for internal and external customers.
  • Ability to multi-task and prioritize efforts effectively.


Travel Requirements

Up to 10% travel, based on business needs

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.

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


This job has expired.

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