Quality Management Manager

3 weeks ago


South Dartmouth, Massachusetts, United States Tonix Pharmaceuticals Full time
Job Description

Tonix Pharmaceuticals is seeking a highly skilled Quality Management Manager to oversee the generation of analytical data for product release, stability, and development. This role will be responsible for implementing and developing quality control expectations on developing product candidates and commercial operations.

The ideal candidate will have a strong background in quality control, with experience in overseeing contract organization generation of analytical data. They will be responsible for analytical development and assay troubleshooting at contract organizations, as well as supporting all aspects of product release, stability trending, and ICH guidance adherence.

This is an exempt (salaried) position that will report directly to the director of QC and be based at the Tonix ADC North Dartmouth, MA location in a hybrid capacity. The successful candidate will have a strong understanding of quality control principles, USP/Ph Eur compendia testing requirements, and various analytical and biochemical testing techniques.

Key Responsibilities:

  • Oversee the in-process and release product testing and stability in support of manufactured drug substance and drug product to ensure the product meets quality attributes performed at contract organizations
  • Oversee the implementation of general laboratory operational systems and testing capabilities, related method transfer and qualification activities, investigations, and assay/instrument troubleshooting
  • Support the development and implementation of new analytical methods as required to meet quality attributes
  • Work with other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate
  • Provide support for the appropriate QC strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance
  • Perform statistical trending of stability data to determine product shelf life
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects to support Tonix on various business initiatives
  • Provides constructive and timely performance evaluations
  • If necessary, handles discipline and termination of employees in accordance with company policy
  • Contributes to performance and compensation decisions such as: merit raises, bonuses, and promotions

Requirements:

  • Bachelor's degree in Chemistry, Biochemistry, or a closely related field with at least eight (8) years of experience in the job offered or any related position in which the required experience was gained (such as Quality Control Chemist, Quality Control Team Leader)
  • At least 8 years of cGMP QC experience in biotechnology/large molecule and small molecule industry
  • At least 8 years of experience with QC principles, USP/Ph Eur compendia testing requirements, and various analytical and biochemical testing techniques
  • Ability for travel 20% of the time
  • Strong planning and organizational skills
  • Comfortable working independently with minimal supervision
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Benefits:

  • Annualized base salary ranges from $90,000 to $150,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit
  • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
  • Retirement Savings 401k with company match and annual discretionary stock options
  • Generous Paid Time Off, Sick Time, & Paid Holidays
  • Career Development and Training

Equal Employment Opportunity:

Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, disability, veterans status, or any other characteristic protected by law.



  • South Dartmouth, Massachusetts, United States SouthCoast Health Full time

    OverviewAt Southcoast Health, we're committed to delivering exceptional patient care and fostering a culture of well-being. As a Practice Manager, you'll play a vital role in leading our ambulatory practice locations, ensuring seamless patient flow and daily operations. Your expertise will be instrumental in managing appointment scheduling, registration,...


  • South Dartmouth, Massachusetts, United States Southcoast Health System Full time

    Job SummaryWe are seeking a highly skilled Clinical Practice Manager LPN to lead our team and drive excellence in patient care. As a key member of our leadership team, you will be responsible for managing the operations of assigned practice(s) and ensuring compliance with policies, procedures, and best practice standards.Key ResponsibilitiesProvide direct...


  • South Dartmouth, Massachusetts, United States SouthCoast Health Full time

    About Southcoast HealthSouthcoast Health is a not-for-profit, charitable health system with multiple hospitals, clinics, and facilities throughout Southeastern Massachusetts and Rhode Island.We are committed to providing inclusive, ethical workplaces where our highly skilled caregivers offer world-class, comprehensive healthcare close to home.Job SummaryWe...


  • South Dartmouth, Massachusetts, United States Walgreens Full time

    Job SummaryWe are seeking a highly skilled and experienced Shift Lead to join our team at Walgreens. As a Shift Lead, you will be responsible for overseeing the daily operations of the store, ensuring that all tasks are completed efficiently and effectively.Key Responsibilities:Opens and closes the store in the absence of store management, including all...


  • South Dartmouth, Massachusetts, United States Waste Connections Full time

    Waste Connections Career OpportunityWaste Connections is seeking a highly skilled Transfer Station Supervisor to join our team in New Bedford, Massachusetts. As a key member of our operations team, you will be responsible for overseeing the daily activities of our transfer stations, ensuring the safety and well-being of our employees, and driving operational...


  • South Dartmouth, Massachusetts, United States Enhabit Home Health & Hospice Full time

    Job SummaryAs a Registered Nurse (RN) Case Manager at Enhabit Home Health & Hospice, you will be responsible for providing high-quality patient care in the comfort of their own homes. This role requires strong clinical skills, excellent communication, and a passion for delivering exceptional patient outcomes.Key Responsibilities• Perform home visits to...


  • South Dartmouth, Massachusetts, United States Southcoast Behavioral Health Full time

    Job SummarySouthcoast Behavioral Health is seeking a skilled Behavioral Health Case Manager to join our team. As a key member of our multidisciplinary team, you will be responsible for managing patient cases with a high degree of clinical knowledge and expertise.Key ResponsibilitiesEnsure patients meet care criteria from admission through discharge.Initiate...


  • South Dartmouth, Massachusetts, United States Citizens Full time

    Job DescriptionAt Citizens, we're committed to helping our clients achieve their financial goals through personalized advice and innovative solutions. As a Private Client Relationship Manager, you'll play a critical role in deepening relationships with our affluent and high-net-worth clients, providing tailored expertise to help them save and grow their...

  • Yard Laborer

    3 weeks ago


    South Dartmouth, Massachusetts, United States Waste Connections Full time

    Job SummaryAs a Yard Laborer at Waste Connections, you will be responsible for performing various tasks related to yard maintenance and site operations.Key ResponsibilitiesPerform yard work, including cutting weeds and maintaining a clean and presentable sitePerform manual labor, including paper picking and ensuring proper care of equipment and...


  • South Dartmouth, Massachusetts, United States Acushnet Full time

    Job OverviewThe Director, Manufacturing at Acushnet Company is responsible for overseeing and managing ball plant manufacturing goals. This role involves overseeing daily operations, including safety, quality, production planning, and resource allocation. The successful candidate will lead strategic execution in line with production capacity, capability, and...


  • South Dartmouth, Massachusetts, United States Fallon Health Full time

    About the RoleFallon Health is seeking a skilled Nurse Practitioner to join our team in providing high-quality care to elderly adults in the community. As a Geriatric Care Nurse Practitioner, you will work closely with our interdisciplinary team to deliver comprehensive care to our participants.Key ResponsibilitiesManage a primary care panel of participants...


  • South Dartmouth, Massachusetts, United States University of Massachusetts Full time

    Job Summary:The University of Massachusetts is seeking an experienced Instructional Designer to join our team. As an Instructional Designer, you will work collaboratively with faculty and subject matter experts to provide pedagogical consultations, course design, and technical support for face-to-face, hyflex, online, and blended learning courses. Your...


  • South Dartmouth, Massachusetts, United States Tegra Medical Full time

    We are seeking a highly skilled Manufacturing Engineer to join our team at Tegra Medical in Dartmouth, MA. As a key member of our manufacturing team, you will be responsible for designing and implementing efficient manufacturing processes that produce high-quality products.Key responsibilities include:Designing and implementing new manufacturing...

  • Server Representative

    4 weeks ago


    South Dartmouth, Massachusetts, United States Sail Loft Full time

    Job Summary:We are seeking a skilled Server to join our team at The Sail Loft, a neighborhood family restaurant known for its high-quality creative dishes and excellent service. As a Server, you will be responsible for providing unparalleled hospitality to our guests and creating unforgettable experiences every day.Key Responsibilities:Understand our...

  • Sales Associate

    3 weeks ago


    South Dartmouth, Massachusetts, United States The Children's Place Full time

    Job Summary: The Sales Associate will be responsible for supporting the Store Leadership Team to achieve all company goals and initiatives. The Sales Associate will model and maintain excellent customer service with effective communication, product knowledge, and appropriate selling techniques. The Sales Associate will maintain company standards of all...

  • Server

    4 weeks ago


    South Dartmouth, Massachusetts, United States Sail Loft Full time

    About The Sail LoftWe are a neighborhood family restaurant with a passion for providing exceptional dining experiences. Our menu offers a variety of options for everyone, and we take pride in our high-quality creative dishes paired with excellent service.Job SummaryWe are seeking a skilled Server to join our team at The Sail Loft. As a Server, you will be...


  • South Dartmouth, Massachusetts, United States Drive Line Service Full time

    Job Summary:Retail Merchandising Specialists are needed to provide high-quality retail services to the largest retailers in the United States. This is a flexible, variable hour position with hours that depend on business and project needs.Key Responsibilities:Visiting various retail locations within 25 miles of your home to audit products, count inventory,...


  • South Dartmouth, Massachusetts, United States Joe's Original Full time

    Role OverviewAt Joe's Original, we're seeking a skilled Front of House Representative to join our team. As a key member of our front-of-house staff, you'll be responsible for creating an exceptional guest experience from start to finish. Your primary duties will include welcoming guests, managing the wait list, and ensuring seamless communication between the...

  • Dunkin' Shift Leader

    3 weeks ago


    South Dartmouth, Massachusetts, United States Dunkin' Full time

    Job Summary:Couto Management, the operator of Dunkin' shops in Eastern Massachusetts, is seeking a Shift Leader to join our team. As a Shift Leader, you will assist management with training and supervising employees, completing weekly reports, and maintaining records. You will also be responsible for ensuring excellent customer service and preparing food and...

  • Pharmacy Technician

    3 weeks ago


    South Dartmouth, Massachusetts, United States CVS Health Full time

    Pharmacy Technician Job DescriptionCareers at CVS Health are built around the idea of helping people on their path to better health. As a Pharmacy Technician, you will play a vital role in delivering compassionate care to our millions of patients every day.Key Responsibilities:Manage all assigned pharmacy workstations and tasks to support the team's ability...