Director, Clinical Quality Assurance - New Jersey Staffing : Job Details

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 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.

Reporting to the Sr. Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the clinical development team, and collaborates on other related activities performed by Clinical Operations and Medical Departments. This role provides support and promotes collaboration internally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.

Responsibilities (Essential Role Responsibilities):

• Establish and maintain a risk-based and scientific-based quality system to support GCP.
• Oversee regulatory agency inspections and vendor audits.
• Ability to ensure that a strategic audit plan is developed, designed and implemented, and that the activities are conducted, and reports written according to SOPs and regulations.
• Oversee GCP activities (including internal or external audit observations and development of adverse trends) to ensure patient safety and data integrity.
• Supports strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.
• Supports the evaluation and acceptability of vendors for potential use and provides direction, guidance and strategy for company Quality Assurance.
• Full understanding of and practical experience establishing and fostering compliance with ICH E6 Guideline for Good Clinical Practice.
• Provide support and coaching to other staff members to develop additional quality and auditing resources.
• Manage quality documentation in Veeva. (SOPs, CAPAs, Deviations, etc.)

Required and/or Preferred Skills, Experience and Education:

• Minimum BS degree in Chemistry or related life sciences discipline required with minimum 8-12 years of experience.
• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
• Requires solid experience supporting Phases I-IV (particularly Phase III); experience with Regulatory submissions and/or approval.
• Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
• Experience with combination products a plus.
• Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.
• Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice.
• Must be able to foster a collaborative environment, adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
• Must be able to prioritize work effectively to meet timelines.
• Excellent written/oral communications skills and presentation skills.
• Highly organized with a strong attention to