IT Change Control Manager
Insmed Incorporated

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

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.

Overview

An IT Change Control Manager is responsible for overseeing and facilitating the harmonized IT Change Control Process within the IT organization. Key responsibilities include, Process Oversight, Running CAB meetings, Communication, Documentation Review and Coordination of GxP Changes.

Responsibilities

Overall Responsibilities:

• Own and facilitate the adoption of the IT Change Control Process within the IT organization and its stakeholder groups.
• SOP creation and maintenance, through periodic reviews, of the process with system owners and affiliated stakeholders
• Super User level knowledge of the IT Change Control workflows.
• Train new or existing users to the IT Change Control system as needed.
• Manage access requests to the IT Change Control system.
• Periodic reviews of the change control system and its audit trails to ensure that there are no non-compliant activities.
• Identify and manage required enhancements to the IT Change Control system.
• Coordinate with the system owner for any enhancements, patches and releases to the system.
• Through partnering, seeks to maintain awareness of undisclosed or unreported changes and direct them towards the change control process.
• Partner with the GxP Change Control process and ensure the GxP Systems are processed per the appropriate processes.

Day-to-Day tasks

• Setup a cadence for IT CAB meetings and manage meetings.
• Create agendas, and any pre-read materials for the CAB Meeting and distribute it to the CAB members prior to the meeting.
• Run the CAB meeting and take notes and action items.
• Capture and publish the minutes from the CAB meeting and track follow-ups according to agreed actions.
• Facilitate communication and coordination of emergency changes.
• Guide users as to which Change Control workflow to pick for their Change Control
• Ensure changes follow their workflows and appropriate approvals are received before changes are implemented. Follow up with change owners as needed.
• Review any required documentation as stated in the change prior to closing changes. Ensure documentation is uploaded to appropriate folders/records as decided by the process.
• Ensure action items are closed before the Change Control is closed.
• Communicate change statues with the change owner as appropriate.
• Provide weekly/monthly metrics and any additional ad-hoc reports as necessary.
• Work with change owners to close out their changes in a timely manner.

Qualifications

• Familiar with ServiceNow and ITIL.
• Familiarity with GxP and 21 CFRPart11 requirements is preferred.
• Bachelors' Degree and 6 + years of experience in IT

Salary Range

$111,000 - $156,133 a year

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.

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.

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