Current jobs related to Associate Director, Inspection Readiness - Bridgewater - Insmed Incorporated

  • Director, Head of Clinical Quality Assurance

    3 months ago

    Bridgewater, United States Gan & Lee Pharmaceuticals Full time

    Job DescriptionJob DescriptionSummaryThis position reports to the CEO, Gan & Lee Pharmaceuticals. Regular specific interaction also occurs with the President and CEO of Gan & Lee Pharmaceuticals USA. The Clinical Quality Director leads all GxP (GCP mostly) audits/inspections at the US Affiliate.Education and CredentialsCollege degree in a relevant field....

  • Director of Nursing

    1 week ago

    Bridgewater, United States VitalCore Health Strategies Full time

    Join the VitalCore Team in Massachusetts! We’re people fueled by passion, not by profit.?VitalCore Health Strategies (VCHS), an industry leader in Correctional Healthcare, has an opening for?a Director of Nursing / Registered Nurse at Massachusetts Department of Correction Old Colony Correctional Center in Bridgewater, MA.At VitalCore we pride ourselves on...

  • Director of Nursing

    2 weeks ago

    Bridgewater, United States VitalCore Health Strategies Full time

    Job DescriptionJob DescriptionJoin the VitalCore Team in Massachusetts! We’re people fueled by passion, not by profit.  VitalCore Health Strategies (VCHS), an industry leader in Correctional Healthcare, has an opening for a Director of Nursing / Registered Nurse at Massachusetts Department of Correction Old Colony Correctional Center in Bridgewater,...

  • Director of Maintenance

    1 month ago

    Bridgewater, United States Mira Vie at Green Knoll Full time

    Job DescriptionJob DescriptionWelcome to Distinctive Living, we're seeking a Director of Plant Operations (Full-Time) for our Mira Vie Green Knoll community.Here at Distinctive Living, we want our people to realize their full potential. We're passionate about personal and professional growth and will do everything we can to help you flourish. We...

  • Store Associate Part-Time

    3 months ago

    Bridgewater, United States DSW Full time

    You must apply through our internal portal: ** Store Associate Part-Time** DATE: May 20, 2021 CITY: Bridgewater BRAND: DSW REQ #: 115369 LOCATION NAME: Best Buy Shopping Center, Bridgewater DEPARTMENT: Stores **General Summary** Store Associates provide friendly service to customers shopping in-store and those engaging through omni-channel services. They...

  • Associate Director, Talent Acquisition

    1 month ago

    Bridgewater, United States Insmed Incorporated Full time

    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...

  • Director, Patient Access

    3 weeks ago

    Bridgewater, United States Amneal Pharmaceuticals Full time

    JOB SUMMARY The Director of Patient Access & Affordability is a critical leadership position which will oversee Amneal's Patient Support Operations focused on developing brand level strategies and solutions to enhance patient access and affordability experience across the product portfolio in the US Market. This critical position reports to the VP of Market...

  • Warehouse Associate

    4 weeks ago

    Bridgewater, United States Kelly Full time

    Job Title: Warehouse Distribution AssociateJob Type: Full-Time1st Shift: 8AM-5PMPay Rate: $22-$24 HourlyLocation: Bridgewater, MAJob Summary: We are seeking a motivated and detail-oriented Warehouse Distribution Associate to join our dynamic team. In this role, you will be responsible for efficiently handling and processing incoming and outgoing shipments,...

  • Warehouse Associate

    4 weeks ago

    Bridgewater, United States Kelly Full time

    Job Title: Warehouse Distribution AssociateJob Type: Full-Time1st Shift: 8AM-5PMPay Rate: $22-$24 HourlyLocation: Bridgewater, MAJob Summary: We are seeking a motivated and detail-oriented Warehouse Distribution Associate to join our dynamic team. In this role, you will be responsible for efficiently handling and processing incoming and outgoing shipments,...

  • Logistics Associate

    1 week ago

    Bridgewater, Massachusetts, United States VISTAR Full time

    Job Overview:Delivering Excellence:At Vistar, we offer competitive compensation and a comprehensive benefits package that includes immediate Health & Wellness Benefits, Employee Stock Purchase Plan, 401K Employer Matching, Education Assistance, Paid Time Off, and more.We provide opportunities for career advancement while performing vital tasks that support...

  • Director of Sales and Marketing

    7 days ago

    Bridgewater, United States Mira Vie at Green Knoll Full time

    Job DescriptionJob DescriptionWelcome to Distinctive Living, we're seeking a Director of Sales and Marketing (Full-Time) for our (Community Name & Location)Here at Distinctive Living, we want our people to realize their full potential. We're passionate about personal and professional growth and will do everything we can to help you flourish. We...

  • Front Desk Associate

    3 months ago

    Bridgewater, United States Gold's Gym Full time

    Front Desk Associate Gold's Gym Bridgewater is looking for a Front Desk Associate ready to start a fitness career. Must have availability during the day and on weekends. Without experience on DataTrak software the position is entry-level with the opportunity to grow. The Front Desk Associate will greet and direct members, guests, and staff as they enter the...

  • Director of Operations

    4 weeks ago

    Bridgewater, United States Perdue Farms Full time

    Perdue Foods is part of Perdue Farms, a family-owned company heading into its second century of growth and innovation. With a goal of becoming the most trusted name in premium proteins, we create products for consumers and for retail and foodservice customers around the globe, while changing the way animals are raised for food.SummaryWe are actively...

  • Associate Director, Tech Ops

    1 month ago

    Bridgewater, United States Insmed Incorporated Full time

    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...

  • Associate Attorney

    1 day ago

    Bridgewater, Massachusetts, United States Jobot Full time

    About the RoleWe are seeking a highly skilled and motivated Associate Attorney to join our team at Jobot. As a key member of our legal team, you will be responsible for providing exceptional legal services to our clients, while also contributing to the growth and success of our law firm.Key ResponsibilitiesLegal Research and Analysis: Conduct thorough...

  • Production Associate

    2 weeks ago

    Bridgewater, Massachusetts, United States Rastelli Bros Full time

    Job OverviewPosition: Production AssociateResponsibilities:Efficiently pack both fresh and frozen goods while accurately tracking quantities to fulfill orders. Conduct regular visual inspections to ensure product quality.Utilize RF Scanning technology for inventory management.Adhere to all standard operating procedures, company policies, and safety...

  • Corporate Counsel, Director

    2 weeks ago

    Bridgewater, United States Amneal Pharmaceuticals Full time

    Job Summary The Corporate Counsel, Director Commercial Contracts is an integral member of the legal team responsible for the day-to-day coordination of legal work on commercial contracts and commercial operations. More specifically, s/he will be responsible for, at the direction of the Associate General Counsel or his/her designee, (i) handling the...

  • Senior IT Director, Americas

    1 week ago

    Bridgewater, Massachusetts, United States PVH Corp. Full time

    About PVH Corp.We are a global leader in the apparel industry, driven by our passion for building iconic lifestyle brands. Our mission is to create a workplace environment where every individual is valued, and every voice is heard.We strive to foster an inclusive and diverse community of associates with a strong sense of belonging.We are committed to driving...

  • 2L Summer Law Associate

    2 months ago

    Bridgewater, United States KECHES LAW GROUP PC Full time

    Job DescriptionJob DescriptionDescription:2L Summer Associate ProgramKeches Law Group will be hiring students who are seeking a highly personalized summer experience for our Summer Associate program. Students will be immersed in their assigned practice area for the duration of the program.Associates may be placed in our Bridgewater, MA or Milton, MA...

  • Production Associate

    1 week ago

    Bridgewater, Massachusetts, United States Rastelli Bros Full time

    Job OverviewRastelli Food Groups has been a leader in the food industry, providing top-quality products and services since 1976. Our offerings are enjoyed in premier hotels, restaurants, institutions, and retail markets, catering to families everywhere.We are currently seeking dedicated individuals for the role of Production Associate in our facility.Key...

Associate Director, Inspection Readiness

1 month ago

Bridgewater, United States Insmed Incorporated Full time

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 three 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

Reporting to the Director of Clinical Quality Systems, the Associate Director, Inspection Readiness serves as Clinical Inspection Readiness lead for Insmed. The incumbent will support and collaborate with the Clinical Development functions in establishing Inspection Readiness strategy, tools and guidance, and the promotion of proactive, inspection-ready compliance in the execution of clinical trials.

Responsibilities

Responsibilities:Utilize a risk based quality management approach to facilitate the set-up and implementation of a framework for Inspection Readiness:

Act as the Business process Owner for Inspection Readiness Collaborate with cross functional teams to establish strategy, tools and guidance in support of inspection readiness Ensure inspection ready procedures are appropriate to functional responsibilities and clinical trial phases Partner with Program leads and the Clinical Compliance Manager to ensure cross-functional buy-in of inspection readiness activities and their effective implementation Monitor and track inspection readiness activities and outcomes across programs, ensuring best practices are shared and adopted Provide inspection readiness coaching to other staff members Work with the Insmed's Regulatory Intelligence team to maintain a current awareness of regulations and regulatory inspection outcomes Support regulatory inspections at Insmed, including the assessment and sharing of  lessons learned, and their implementation in ongoing inspection readiness processes Monitor and track inspection activities, managing the reporting process including facilitation of responses and follow-up corrective and preventive actions

Position Requirements:

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 of participation in regulatory agency inspection and working with regulators and internal staff to help prepare for inspections. An understanding of regulations, development processes and regulatory inspection procedures is required. An understanding of the sponsor responsibilities in the execution of clinical trials. Experience developing SOPs; reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential. Knowledge of GCP and key regional regulations (US, EMEA and Japan). Experience of risk based quality management with the ability for critical thinking and a problem solving approach. 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 flexibility, with the ability to work independently, and 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.

#LI-JT1#LI-Remote

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 $139,000.00 to $195,200.00 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, regionally based Competitive compensation package including bonus  Stock options and RSU awards Employee Stock Purchase Plan (ESPP) Flexible Vacation Policy Generous paid holiday schedule and winter break 

ADDITIONAL U.S. BENEFITS:

401(k) plan with company match Medical, dental, and vision plans Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity insurance Employee Assistance Program (EAP) Mental Health on-line digital resource Well-being reimbursement Paid leave benefits for new parents Paid time off to volunteer On-site, no-cost fitness center at our U.S. headquarters

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 for 5 calendar days from the date posted or until the position is filled.