Assoc. Director, Glp/Gclp Quality Assurance

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: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:

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

Qualifications:

• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered
• Ability to manage CAPAs and deviations to closure and perform effectiveness checks
• GLP/GCLP audit experience
• Demonstrated ability to work independently, flexibility and the ability to manage variable workloads
• Knowledge of CLIA and CAP laboratory certification
• Requires robust experience with quality procedures and processes
• Minimum BS degree in Biology or Chemistry or related life sciences discipline required with minimum 5-10 years of experience
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness
• An understanding of regulations, development processes and regulatory inspection procedures is required
• 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
• Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential
• 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
• Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required

Travel Requirements: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:

• Employee stock purchase plan
• Flexible approach to where and how we work
• Professional Judgment Vacation Policy
• 401(k) plan with company match
• Competitive compensation package including bonus.
• Stock options and RSU awards
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).

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

Additional Information: