Current jobs related to Sr Director Quality Assurance Operations - Bridgewater - Insmed Incorporated

  • Sr. Director, Quality Assurance Operations

    2 months ago

    Bridgewater, United States GQR Full time

    Title: Sr. Director, Quality Assurance OperationsLocation: Bridgewater, NJHybrid role: onsite 2-3 days per week, must live near the site or willing to relocate.Status: Full-time direct hireCompensation: $250,000 to $280,000 Ideal candidates will have experience in small molecules, biologics, and combination/ medical devices.Reporting to the Executive...

  • Sr. Director, Quality Assurance Operations

    2 months ago

    Bridgewater, United States GQR Full time

    Title: Sr. Director, Quality Assurance OperationsLocation: Bridgewater, NJHybrid role: onsite 2-3 days per week, must live near the site or willing to relocate.Status: Full-time direct hireCompensation: $250,000 to $280,000 Ideal candidates will have experience in small molecules, biologics, and combination/ medical devices.Reporting to the Executive...

  • Quality Assurance Lead

    4 weeks ago

    Bridgewater, Massachusetts, United States Ready Pac Produce, Inc Full time

    Quality Assurance LeadDepartment: Quality AssuranceLocation: Not SpecifiedShift: Not SpecifiedCertification in HACCP is required.The Quality Assurance Lead role at Ready Pac Produce, Inc. presents a remarkable opportunity to oversee a team focused on maintaining product excellence and safety. Ready Pac Produce, Inc. is a prominent entity in the fresh food...

  • Quality Assurance Specialist

    2 weeks ago

    Bridgewater, Virginia, United States Perdue Farms Full time

    Job SummaryPerdue Farms, a leading provider of premium proteins, is seeking a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesMonitor Production Processes: Ensure all products meet company quality and food safety...

  • Quality Assurance Specialist

    2 weeks ago

    Bridgewater, Massachusetts, United States Healgen Scientific Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our team at Healgen Scientific. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Assist in the development and implementation of quality systems and procedures to...

  • Quality Assurance Specialist

    1 day ago

    Bridgewater, Virginia, United States Perdue Farms Full time

    {"title": "Quality Assurance Specialist", "content": "Job SummaryPerdue Farms is a leading provider of premium proteins, and we're seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring that our products meet the highest standards of quality and safety.Key ResponsibilitiesMonitor...

  • Quality Assurance Specialist

    2 weeks ago

    Bridgewater, Massachusetts, United States Healgen Scientific Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our team at Healgen Scientific. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Assist in the development and implementation of quality systems and procedures to...

  • Quality Assurance Inspector

    4 weeks ago

    Bridgewater, Massachusetts, United States Aerotek Full time

    Job Title: Quality Assurance InspectorJob OverviewAs a Quality Assurance Inspector, you will be responsible for conducting thorough inspections to determine the acceptability of incoming materials intended for packaging operations. Your role will also encompass the evaluation and testing of products during various stages of production, ensuring that only...

  • Quality Assurance Specialist

    1 week ago

    Bridgewater, Virginia, United States Perdue Farms Full time

    {"title": "Quality Assurance Specialist", "content": "Job SummaryPerdue Farms is a leading provider of premium proteins, and we're seeking a Quality Assurance Specialist to join our team. As a key member of our quality control team, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Key...

  • Aviation Quality Assurance Specialist

    4 weeks ago

    Bridgewater, Virginia, United States Leidos Full time

    Position Overview Are you prepared to take on a pivotal role in aviation quality assurance? At Leidos, we are committed to delivering exceptional solutions through the dedication of our diverse workforce, all focused on achieving our clients' goals. We value our teams, support our communities, and prioritize sustainable practices. Our Mission, Vision, and...

  • Aviation Quality Assurance Specialist

    4 weeks ago

    Bridgewater, Virginia, United States Leidos Holding Full time

    Make a significant impact in aviation quality assurance At Leidos, we provide cutting-edge solutions through the dedication of our diverse and skilled workforce committed to our clients' success. We empower our teams, engage with our communities, and prioritize sustainability. Our operations are grounded in a commitment to integrity for our clients, our...

  • Director, Head of Clinical Quality Assurance

    15 hours ago

    Bridgewater, United States Gan & Lee Pharmaceuticals Full time

    Job DescriptionJob DescriptionSummaryThis position reports to 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. Life Sciences Preferred.ExperienceAt least 10 years in relevant quality auditor roles...

  • Aviation Quality Assurance Specialist

    2 weeks ago

    Bridgewater, Virginia, United States Leidos Full time

    About the RoleWe are seeking a highly skilled Aviation Quality Control Engineer to join our team at Leidos. As a key member of our Integrated Airborne Solutions (IAS) Division, you will play a critical role in ensuring the quality and safety of our aviation programs.Key ResponsibilitiesProvide onsite quality oversight and ensure compliance with contractual,...

  • Director of Operations

    1 month 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...

  • FSQA Quality Assurance Specialist

    2 weeks ago

    Bridgewater, Massachusetts, United States Aspire Bakeries Full time

    About Aspire BakeriesAspire Bakeries is a leading North American baking company with a strong presence in the specialty frozen baked goods market. Our innovative food portfolio includes a wide range of products such as breads, artisan breads, buns, cookies, donuts, muffins, and pastries from well-known brands.We have 13 bakeries across North America, and our...

  • Sr. Quality Control Analyst

    1 month ago

    Bridgewater, United States Clinical Resource Network (CRN) Full time

    Our client is looking to fill the role of Sr. Quality Control Analyst. This opportunity will be onsite in the Somerset, NJ area.Responsibilities:In-process materials, raw materials, finished product, or stability sample analysisSupporting cell therapy products and associated assaysResponsible for analytical test review and internal audit supportPrepare...

  • Quality Assurance/ HACCP LEAD

    1 month ago

    Bridgewater, United States Perdue Farms Full time

    Perdue Foods is part of Perdue Farms, a family-owned company heading into it's 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.SummaryTraining HACCP...

  • FSQA Technician

    2 weeks ago

    Bridgewater, Massachusetts, United States Aspire Bakeries Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented FSQA Technician to join our team at Aspire Bakeries. As a key member of our Food Safety and Quality Assurance team, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesFood Safety and Quality AssuranceConduct regular food safety and quality...

  • Sr. Operations Manager

    3 weeks ago

    Bridgewater, Massachusetts, United States Aspire Bakeries Full time

    About the RoleAspire Bakeries is a leading North American baking company with a strong presence in the specialty frozen baked goods market. We are committed to driving innovation, predicting consumer trends, and exceeding customer expectations.The Sr. Operations Manager, Startup will play a critical role in the implementation of our new manufacturing line....

  • Dental Director of Operations

    3 weeks ago

    Bridgewater, United States Dentele Group Full time

    Job DescriptionJob DescriptionThe Director of Operations is an executive position responsible for overseeing the operations of an organization. This role requires strong leadership, strategic thinking, and operational expertise. This position works closely with the executive team to develop and implement strategic plans to ensure efficient and effective...

Sr Director Quality Assurance Operations

4 months 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 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 Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

  

Overview

Reporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA and QC 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. This is a supervisory position with 3-6 individual direct reports.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following: 
  • 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 monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & procedures
  • Lead overall management of Quality Assurance programs to support the QC lab and to ensure they are meeting expectations, which include oversight of raw material qualification, lab investigations, stability program, etc
  • Provide oversight of QC equipment program, which includes qualification, calibration, PM, etc
  • Review and approve deviations, CAPAs, SOPs and Change Control related to QC Lab and operations
  • Partners 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 required
  • Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.
  • Commercial drug manufacturing site QA head experience preferred
  • Ability 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 action
  • Ability 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 guidelines
  • Solid knowledge of all QC laboratory equipment and manufacturing equipment
  • Direct 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 $200,000.00 to $280,000.00 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.