Current jobs related to Sr Director, Quality Assurance Operations - Brockton, Massachusetts - Insmed Incorporated

  • Director of Quality Assurance Operations

    5 days ago

    Brockton, Massachusetts, United States Insmed Incorporated Full time

    Job Title: Director, Quality Assurance OperationsInsmed Incorporated is seeking a highly skilled and experienced Director, Quality Assurance Operations to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products and processes, and for leading our quality operations...

  • Clinical Quality Assurance Director

    2 weeks ago

    Brockton, Massachusetts, United States Gan & Lee Pharmaceuticals Full time

    Job Title: Clinical Quality Assurance DirectorThis is a senior leadership role within Gan & Lee Pharmaceuticals USA, reporting directly to the President and CEO. The Clinical Quality Assurance Director is responsible for leading all GxP audits/inspections at the US Affiliate.Key Responsibilities:Develop and implement audit plans and risk mitigation...

  • Associate Director, Pipeline Quality Assurance

    5 days ago

    Brockton, Massachusetts, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking an experienced Associate Director, Pipeline Quality Assurance to join our team. In this role, you will be responsible for directing all quality-related activities and processes for a pipeline product in clinical phase studies.Key ResponsibilitiesEstablish and maintain a risk-based and scientific-based quality system and...

  • Associate Director, Pipeline Quality Assurance

    3 weeks ago

    Brockton, Massachusetts, United States BioSpace, Inc. Full time

    Job DetailsCompany OverviewInsmed is a global biopharmaceutical company dedicated to transforming the lives of patients living with serious and rare diseases. Our mission is to foster a collaborative environment where our team can thrive, driven by a patient-first mentality. We are committed to growing our team with talented individuals from around the world...

  • Quality Assurance Auditor

    2 weeks ago

    Brockton, Massachusetts, United States Paragon Staffing, LLC Full time

    Job DescriptionParagon Staffing, LLC is a leading staffing agency that connects job seekers with top employers. We are currently seeking a Quality Assurance Auditor to join our team in Somerset, NJ.Job Summary:The Quality Assurance Auditor will be responsible for ensuring that products meet established standards of appearance and performance. This includes...

  • Aviation Quality Assurance Lead

    4 weeks ago

    Brockton, Massachusetts, United States Leidos Holding Full time

    Job Title: Aviation Quality Assurance LeadLeidos is seeking an experienced Aviation Quality Assurance Lead to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest level of quality in our aviation programs.Key Responsibilities:Manage a team of quality personnel to ensure aviation-related programs meet...

  • Quality Assurance Specialist

    4 weeks ago

    Brockton, Massachusetts, United States cyberThink Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Engineer to join our team at cyberThink Inc. in Bridgewater, NJ.Key Responsibilities:Perform end-to-end mobile testing to ensure the highest quality of our products.Develop and execute test scripts using C/C++/C# languages.Conduct System Integration Testing using bi-directional TCP protocol in...

  • Software Quality Assurance Specialist

    3 weeks ago

    Brockton, Massachusetts, United States Daikin Full time

    Software Quality Assurance SpecialistDaikin is seeking a skilled Software Quality Assurance Specialist to join our team. As a key member of our QA team, you will be responsible for ensuring the quality of our software products.Key Responsibilities:Develop and execute test plans to ensure software meets requirementsCollaborate with development team to...

  • Quality Assurance Technician

    2 weeks ago

    Brockton, Massachusetts, United States Quick Hire Staffing Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Technician to join our team at Quick Hire Staffing. As a Quality Assurance Technician, you will be responsible for ensuring the quality of our products by performing physical property testing, maintaining accurate test data, and monitoring temperature and humidity control.Key ResponsibilitiesRead...

  • Software Quality Assurance Specialist

    3 weeks ago

    Brockton, Massachusetts, United States Daikin Full time

    Software Quality Assurance SpecialistDaikin is seeking a skilled Software Quality Assurance Specialist to join our team. As a key member of our QA team, you will be responsible for ensuring the quality of our software products.Key Responsibilities:Develop and execute test plans to ensure software meets requirementsCollaborate with development team to...

  • Aviation Quality Assurance Lead

    3 weeks ago

    Brockton, Massachusetts, United States Leidos Holding Full time

    Job SummaryWe are seeking an experienced Aviation Quality Assurance Lead to join our team at Leidos Holding. As a key member of our Integrated Airborne Solutions (IAS) Division, you will be responsible for providing critical aviation maintenance quality oversight for various programs and projects.Key ResponsibilitiesEnsure compliance to operating procedures...

  • Principal Engineer

    4 weeks ago

    Brockton, Massachusetts, United States Baxter Full time

    About the RoleWe are seeking a highly skilled Principal Engineer to join our Quality Assurance team at Baxter. As a Principal Engineer, you will play a critical role in ensuring the quality and safety of our medical devices, specifically our Peritoneal Dialysis products.Key ResponsibilitiesProvide quality oversight and mentorship to project teams, ensuring...

  • Operations Director

    2 weeks ago

    Brockton, Massachusetts, United States Customer Driven Industrial Company Full time

    Job SummaryWe are seeking a highly skilled and experienced Director of Operations to join our team at Customer Driven Industrial Company. The successful candidate will be responsible for overseeing the effective management of our business, from order receipt to completion, and will play a key role in driving strategy for the company.Key...

  • Food Safety and Quality Assurance Specialist

    1 month ago

    Brockton, Massachusetts, United States Jobot Full time

    Job SummaryWe are seeking a highly skilled Food Safety and Quality Specialist to join our dynamic manufacturing team. As a key member of our team, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Key ResponsibilitiesEnsure compliance with all federal, state, and local regulations regarding food safety...

  • Food Safety and Quality Assurance Specialist

    3 weeks ago

    Brockton, Massachusetts, United States Jobot Full time

    Job Title: Food Safety and Quality SpecialistWe are seeking a highly skilled Food Safety and Quality Specialist to join our dynamic manufacturing team. As a key member of our team, you will be responsible for ensuring the highest standards of food safety and quality in our products.Responsibilities:Ensure compliance with all federal, state, and local...

  • Food Safety and Quality Assurance Specialist

    3 weeks ago

    Brockton, Massachusetts, United States Jobot Full time

    Job Title: Food Safety and Quality SpecialistWe are seeking a highly skilled Food Safety and Quality Specialist to join our dynamic manufacturing team. As a key member of our team, you will be responsible for ensuring the highest standards of food safety and quality in our products.Responsibilities:Ensure compliance with all federal, state, and local...

  • QC Scientist

    2 weeks ago

    Brockton, Massachusetts, United States STERIS Full time

    Job Title: QC Scientist - Quality Assurance SpecialistSTERIS is seeking a highly skilled QC Scientist to join our team in Plymouth, MN. As a key member of our quality assurance team, you will be responsible for generating leading quality control initiatives, developing test methods, and troubleshooting lab and product issues in accordance with ISO, FDA QSR,...

  • Fiber Network Quality Assurance Manager

    1 week ago

    Brockton, Massachusetts, United States Ripple Fiber Inc Full time

    About Ripple FiberWe are a dynamic and innovative company that provides access to the best internet for life, bridging the digital divide using advanced technology. Our mission is to provide faster, more stable fiber internet connections, offering each user their own bandwidth without sharing. Our goal is to provide internet access to over 3 million homes...

  • Operations Director

    3 weeks ago

    Brockton, Massachusetts, United States Xactly byGTE Full time

    Operations Manager Job DescriptionXactly byGTE is seeking an experienced Operations Manager to oversee the efficient and effective operation of multiple divisions within a company, including construction, restoration, and administration.Key Responsibilities:Develop and implement annual operational plans and budgets with the executive team.Set and monitor...

  • Director of Operations

    3 weeks ago

    Brockton, Massachusetts, United States CyberCoders Full time

    Director of OperationsCyberCoders is seeking a seasoned Director of Operations to lead our process piping division. As a key member of our team, you will be responsible for developing and implementing strategies to drive growth and profitability.Key Responsibilities:Develop and execute business plans to expand our process piping specialty divisionEstablish...

Sr Director, Quality Assurance Operations

3 months ago

Brockton, Massachusetts, 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 two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in BiopharmaTM, Best Workplaces in New YorkTM, and Best Workplaces for MillennialsTM lists.



Overview

Reporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical supplier relationships and active Quality engagement with these suppliers.



Responsibilities

Responsibilities:

Responsible for final product Quality release/rejection and related processes.Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues. Impact assessment includes proper evaluation for Health Authority reporting (FAR, Quality Defect, Recalls, etc) and escalation within QA.Responsible for supplier day to day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent supply.Review and approve deviations, CAPAs, SOPs and Change Control related to manufacturing operationsPartners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP).Responsible for QA representation in Design Control Process for medical device products and combination products.Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects.Manage the performance and development of 3-6 direct reports.Support supplier and internal audits as necessary.Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc.Act as company's representative during regulatory agencies and customer inspections.Supports the investigation of product and related CAPAs. Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department.Support Statistical Trending of Manufacturing and Analytical Data.Additional duties as assigned

Qualifications: BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience requiredMinimum 7 years' experience working in 21CFR211 regulated environment requiredExtensive knowledge of cGMPs and pharmaceutical and medical device manufacturing quality assurance.Commercial drug manufacturing site QA head experience preferredAbility to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.Ability to solve complex problems and take proactive actionAbility to motivate a team, recognize and develop good talent and bring out the best out of each individual.Maintain professionalism, self-motivation, and enthusiasm.Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing.Must perform statistical analysis and capable of analyzing data to solve problemsDirect experience with investigations and root cause analysis in pharmaceutical or medical device products.Experience with internal and external audits.Experience reviewing manufacturing validation documents.Preferred ASQ CQE and CQA Certifications.Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971.Demonstrate ability to manage projects and variable workloads.Excellent communication and coaching skills (verbal and written). Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).#LI-JT1

Qualifications

BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug manufacturing site QA head experience preferredAbility to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.Ability to solve complex problems and take proactive actionAbility to motivate a team, recognize and develop good talent and bring out the best out of each individual.Maintain professionalism, self-motivation, and enthusiasm.Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing.Must perform statistical analysis and capable of analyzing data to solve problems Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelinesSolid knowledge of all QC laboratory equipment and manufacturing equipmentDirect experience with investigations and root cause analysis in pharmaceutical or medical device products.Experience with internal and external audits.Experience reviewing manufacturing and QC validation documents.Preferred ASQ CQE and CQA Certifications.Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971.Demonstrate ability to manage projects and variable workloads.Excellent communication and coaching skills (verbal and written). Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Travel Requirements

Up to 30% travel, both domestic and/or international.



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 $207,000.00 to $289,867.00 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 basedCompetitive compensation package including bonus Stock options and RSU awardsEmployee Stock Purchase Plan (ESPP)Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS:401(k) plan with company matchMedical, dental, and vision plansCompany-provided Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance Program (EAP)Mental Health on-line digital resourceWell-being reimbursementPaid leave benefits for new parentsPaid time off to volunteerOn-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.