Manager, Quality Control

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

The Manager of Quality Control will serve as a strategic and tactical quality professional in ensuring oversight and execution of all aspects of commercial GMP related analytical testing, as well as late stage GMP development testing. Responsible for ensuring oversight of contract laboratories and testing performed by manufacturers of all commercial and late stage development products, including starting materials, in-process, release, and stability testing throughout the product lifecycle. Accountable for assemble, review and trending the release, IPC, and stability data. This role supports Insmed quality culture through collaborating externally and internally to ensure method transfers, method validation, and QC data integrity is established and maintained for the late phase development and commercial programs.

Responsibilities

Responsibilities

• Handles contract laboratory vendors, supervises laboratory performance, assesses capability, and ensures actions are taken to improve if needed.
• Point person for weekly communications with external labs for status updates and testing activities.
• Measure performance against established Key Performance Indicators (critical metrics), thereby consistently ensuring timely and accurate testing, reporting, and release.
• This role will review, assemble and trend release, IPC, and stability data, generating reports as necessary.
• Lead and assist in identifying changes to the processes and impact on the product quality and established procedures.
• Ensures all Out of Specification / Out of Trend results are thoroughly investigated with root cause identified and appropriate corrective actions implemented.
• Handle method transfer, method development and validation activities at external lab site
• Notifies laboratory management when unusual results, trends, or data deviations occur.
• Presenting potential issues/obstacles and advancing as vital
• Assist in the development of new processes and process improvements.
• Cross-functional liaison working closely with internal collaborators.
• Statistical programming and data management support is a plus.
• Develop statistical analysis plans if needed, including the definition of derived data sets and the design of templates for statistical tables, figures, data listings and/or graphs for clinical summary reports.
• Perform statistical analyses and interpret results of these analyses.
• Supply to internal development projects as the need arises.
• Provide mentorship, support and training to internal / external staff as the need arises.

Requirements:

• The position requires a BS or BA degree or equivalent in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology, physics, science program
• 5+ years in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing.
• Knowledge of QC processes and procedures and GMP regulations and mentorship with shown efficiency in maintaining QC processes for compliance with regulations.
• Expertise in method verification and validation procedures.
• Knowledge of Statistical programming.
• Excellent presentation skills both verbal and written.
• Ability to define problems, collect data, establish facts, and draw valid conclusions required.
• Ability to establish and maintain collaborative working relationships with internal and external partners required.
• Ability to take initiative and work independently while optimally handling timelines required.

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Salary Range

$111,000 - $156,133 a year

Compensation & Benefits

At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

Additional Information

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.