Manager Computer System Validation
Insmed Incorporated

Job Info

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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, 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.

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.

Overview

Manage the Validation Lifecycle for GxP System/Application Implementation Projects Develop CSV Plans and strategies for system implementations following Insmed's CSV SOPs Engage on IT Projects as a key team member. Provide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (e.g. SDLC, IT Change Control) per associated SOPs, 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
• Author CSV Documents (Validation Plans and Summary Reports)
• Assist/co-author requirements, testing, specification, and other validation project deliverables
• Ensure training requirements are complete for project team members (CSV SOP, Test Execution, Gdoc. Etc.)
• Ensure project team members follow laid out CSV plans
• Provide real-time oversight and support during test execution
• Review executed protocols
• Route CSV documents for approval(s)
• Manage & maintain CSV documents in Veeva
• Train, coach, and mentor GxP IT system and business owners

Qualifications

• 5+ years' experience in a management validation role with responsibility for computer systems specifically QMS, LIMS, CTMS, and other Clinical and 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 oversight to Cloud and GxP computer systems validation activities
• Experience validating GxP applications, IT infrastructure, and cloud-based systems
• Experience managing oversight 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

#LI-KM

#LI-Hybrid

Travel Requirements

No travel required.

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $111,000.00 to $156,133.00 per 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
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

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 until the position is filled.

This job has expired.