Assoc. Director, GLP/GCLP Quality Assurance
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 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

Reporting to the Associate Director, Clinical Quality Systems, the Associate Director of Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) serves as the QA lead for GLP and GCLP aspects of drug development. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines.

• This is a non Supervisory role.

Responsibilities

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

• Establish and maintain a risk-based and scientific-based quality system to support GCLP/GLP
• Act as company's GLP/GCLP Quality Assurance representative during regulatory agency inspections
• Ensure that activities are conducted and reported according to SOPs and regulations
• Support the evaluation and acceptability of vendors for potential use and provides direction, guidance and strategy for company
• Audit and evaluate GLP/GCLP vendors for compliance with regulations and procedures
• Maintain and manage QA provided GLP/GCLP trainings
• Manage GLP/GCLP CAPAs and Deviations
• Conduct and manage internal GLP/GCLP process and systems audits
• Facilitate function / department SOP processes
• Support strategic direction with cross functional working groups to identify and mitigate GLP/GCLP quality and compliance issues
• Identify and work with key stakeholders to implement process improvements and demonstrate a collaborative approach to problem solving
• An understanding of and practical experience establishing and fostering compliance with GLP/GCLP regulations and guidelines
• Provide support and coaching to other staff members.

Qualifications

• Minimum BS degree in Biology or Chemistry or related life sciences discipline required with minimum 5-10 years of experience
• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered
• Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required
• An understanding of regulations, development processes and regulatory inspection procedures is required
• Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential
• GLP/GCLP audit experience
• Knowledge of CLIA and CAP laboratory certification
• Ability to manage CAPAs and deviations to closure and perform effectiveness checks
• Requires robust experience with quality procedures and processes
• Must be able to foster a collaborative/partnership environment, adapt to other personalities in a respectful manner that is conducive to goal achievement and team building while maintaining quality and compliance
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness
• Demonstrated ability to work independently, flexibility and the ability to manage variable workloads
• Must exhibit Insmed's five (5) core values of: Respect, Passion, Integrity, Collaboration and Accountability
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

Travel Requirements

Ability to travel both domestic and internationally, approximately 20%-25%

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 $135,000.00 to $188,333.00

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.

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

This job has expired.