Current jobs related to Site Quality Head - Gainesville - Rx Group

  • Route Driver- Service Technician

    3 days ago

    Gainesville, United States United Site Services Full time

    **Route Driver- Service Technician** CAROUSEL_PARAGRAPH * Gainesville, Virginia ** Share Job** ** Job Description** **Primary Purpose** You may not notice United Site Services, but we are always there - at construction sites, industrial facilities and live events all across America. We take pride in providing essential services like portable restrooms,...

  • Heavy Equipment Operator

    1 week ago

    Gainesville, Florida, United States Pinnacle Site Solutions Full time

    Pinnacle Site Solutions: A Leading Commercial Site Work ContractorWe are seeking a skilled Dump Truck Driver to join our team at Pinnacle Site Solutions, a leading commercial site work contractor located in High Springs, Florida. Our company has a diverse portfolio of commercial contracting work and the experience to manage a large variety of projects.Key...

  • Underground Utility Technician

    5 days ago

    Gainesville, Florida, United States Pinnacle Site Solutions Full time

    About Pinnacle Site SolutionsWe are a leading commercial site work contractor located in High Springs, Florida, serving Gainesville, Ocala, Jacksonville, and surrounding areas. Our goal is to deliver extraordinary quality and customer service by partnering with organizations and clients that have a reputation for quality.Job SummaryWe are seeking an...

  • Heavy Equipment Operator

    2 weeks ago

    Gainesville, Florida, United States Pinnacle Site Solutions Full time

    Pinnacle Site Solutions: A Leader in Commercial Site WorkWe are seeking a skilled Dump Truck Driver to join our team at Pinnacle Site Solutions, a leading commercial site work contractor in High Springs, Florida. As a key member of our team, you will play a critical role in delivering materials to sites safely and efficiently.Key Responsibilities:Safely...

  • Underground Utility Installer

    1 week ago

    Gainesville, United States Pinnacle Site Solutions Full time

    Job DescriptionJob DescriptionAre you searching for a stable, steadily growing, innovative commercial construction company?Are you seeking a company with inspiring leaders who genuinely care about your growth and success? Are you interested in working for a company with great benefits and opportunities for advancement?If so, Pinnacle Site Solutions is the...

  • Underground Utility Specialist

    7 days ago

    Gainesville, Florida, United States Pinnacle Site Solutions Full time

    Job OverviewPinnacle Site Solutions is a leading commercial site work contractor seeking an experienced Underground Utility Installer to join our team.We are a stable, steadily growing company with inspiring leaders who genuinely care about your growth and success. Our goal is to deliver extraordinary quality and customer service by partnering with...

  • Site Construction Manager

    4 weeks ago

    Gainesville, Florida, United States PCMS Full time

    Job OverviewA prominent Commercial General Contractor is in search of a meticulous and organized Site Construction Manager to supervise the construction operations of commercial projects.The ideal candidate will possess extensive experience in managing the daily onsite activities of both new and ongoing construction projects from inception to completion....

  • Site Director

    16 hours ago

    Gainesville, Georgia, United States Georgia Mountain Young Full time

    Job SummaryWe are seeking a highly motivated and experienced Site Director to oversee the daily operations of our after school program at the Georgia Mountain Young YMCA. The successful candidate will be responsible for managing a team of Group Leaders, developing and implementing developmentally appropriate activities, and ensuring compliance with licensure...

  • Regional Site Director

    4 weeks ago

    Gainesville, United States Georgia Mountain Young Full time $15 - $18

    Job DescriptionJob DescriptionGEORGIA MOUNTAINS YMCA Job DescriptionJob Title: Regional Site Director (Afterschool, Day Camp) Job Grade: 9FLSA Status: Non-Exempt Reports to: Program Director Revision Date: 05/11/2017 ________________________________________________________________________Position Summary: Oversees all operations of the YMCA after school site...

  • Site Director

    3 months ago

    Gainesville, United States Georgia Mountain Young Full time

    Job DescriptionJob DescriptionPosition Summary: Oversees all operations of the YMCA after school site including management of Group Leaders; Develops and implements developmentally appropriate activities; coordinates after school curriculum; monitors licensure/YMCA policy and procedure compliance; interacts effectively with staff, parents and supervisors...

  • Housekeeping Department Head

    2 days ago

    Gainesville, Florida, United States Hilton University of Florida Conference Center Full time

    About UsHilton University of Florida Conference Center is a dynamic and inclusive work environment that fosters growth, development, and wellbeing. Our commitment to a People First culture is reflected in our approach to employee development, employee benefits, and our dedication to building meaningful relationships. We offer a range of employment benefits,...

  • Construction Quality Assurance Manager

    4 days ago

    Gainesville, Florida, United States Place Services Inc. Full time

    Job Title: Construction Quality Control ManagerPlace Services, Inc. is seeking a highly skilled Construction Quality Control Manager to join our team in Gainesville, FL. As a key member of our Federal Division, you will be responsible for overseeing the daily quality control and safety of our construction projects.About UsPlace Services, Inc. is a leading...

  • Quality Assurance Manager

    1 week ago

    Gainesville, Florida, United States Gpac Full time

    Quality Control Manager Job DescriptionOur client, a leading precast concrete manufacturer, is seeking a Quality Control Manager to join their team. This company is a multi-site precast concrete manufacturer looking for candidates who have a desire for career growth and advancement.By joining their team, you will participate in an industry-leading safety...

  • Engineer Quality Operations

    1 month ago

    Gainesville, United States Exactech Full time

    Job DescriptionJob DescriptionDescriptionThe Engineer Quality Operations shall provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Support the execution of initiatives and projects...

  • Construction Quality Control Manager

    5 days ago

    Gainesville, United States Place Services Inc. Full time

    Place Services, Inc. has an immediate need for a Quality Control Manager (QCM) in our Federal Division for a project in Gainesville, FL.The QCM will be responsible for overseeing the onsite daily quality control and safety of PSI Federal Construction projects.Who We Are:Place Services Inc. is a leading commercial construction company based in Canton,...

  • Construction Quality Control Manager

    2 days ago

    Gainesville, United States Place Full time

    Place Services, Inc. has an immediate need for a Quality Control Manager (QCM) in our Federal Division for a project in Gainesville, FL.The QCM will be responsible for overseeing the onsite daily quality control and safety of PSI Federal Construction projects.Who We Are:Place Services Inc. is a leading commercial construction company based in Canton,...

  • Construction Quality Control Manager

    5 days ago

    gainesville, United States Place Services Inc. Full time

    Place Services, Inc. has an immediate need for a Quality Control Manager (QCM) in our Federal Division for a project in Gainesville, FL.The QCM will be responsible for overseeing the onsite daily quality control and safety of PSI Federal Construction projects.Who We Are:Place Services Inc. is a leading commercial construction company based in Canton,...

  • Construction Quality Control Manager

    5 days ago

    Gainesville, United States Place Services Inc. Full time

    Place Services, Inc. has an immediate need for a Quality Control Manager (QCM) in our Federal Division for a project in Gainesville, FL.The QCM will be responsible for overseeing the onsite daily quality control and safety of PSI Federal Construction projects.Who We Are:Place Services Inc. is a leading commercial construction company based in Canton,...

  • Quality Assurance Engineer

    4 weeks ago

    Gainesville, Georgia, United States Jobot Full time

    Quality Assurance Engineer required for a prominent global manufacturer in the Automotive and Industrial sectorsAbout Us:We are a leading innovator in gear technology, catering to the global automotive and industrial sectors with precision and creativity. With a workforce exceeding 3,000 across various international sites, we merge extensive expertise with...

  • Quality Assurance Engineer

    4 weeks ago

    Gainesville, Georgia, United States Jobot Full time

    Quality Assurance Engineer sought for a prominent global manufacturer in the Automotive and Industrial sectorsAbout Us:We are a leading innovator in gear technology, catering to worldwide automotive and industrial markets with precision and creativity. With a workforce exceeding 3,000 across various international sites, we merge extensive expertise with...

Site Quality Head

3 months ago

Gainesville, United States Rx Group Full time

Rx Group is supporting a fast-growing CDMO in the Gene Therapy space, who are recruiting a Site Quality Head, at director or senior director level. You will be responsible for leading the QA organization and working with internal and client teams to establish a quality strategy and implement and manage a PQS that meets all applicable global quality requirements at the site.


Requirements:


  • Provide strategic leadership and direction to the entire QA organization including Quality systems, Quality Operations and Validation.
  • Oversee the development, implementation and maintenance of robust quality systems and procedures in accordance with cGMP and relevant regulatory guidelines including corporate requirements.
  • Responsibility for quality decisions affecting the site.
  • Leading interactions with customers.
  • Participate in internal/external audits, ensuring timely and effective corrective actions.
  • Establish quality KPIs and track them.
  • Lead/facilitate the Quality management reviews.
  • Leading Critical and Major Change Controls, Deviations and CAPA investigations and evaluating their potential impact on Customers, Operations, facilities, analytical results, and product quality.
  • Ensuring GMP-compliant validation and qualifications.
  • Lead the development and execution of a comprehensive training program for the QA team. Providing training of PQS procedures to staff.
  • Reviewing documents, test results, and summary reports for compliance and regulatory requirements.
  • Acting as the QA SME on new and emerging regulations.
  • Point of contact for Quality topics for Customers and Qualified Person(s)
  • Manage the QA budget and ensure efficient resource allocation.
  • Ensuring a safe work environment.
  • Foster a culture of continuous improvement within the QA organization.


Qualifications and Experience:


  • 15 years of experience in biologics manufacturing with 10 years in a leadership role within Quality Assurance. CGT experience a plus.
  • Bachelor's Degree in Life Sciences, Engineering, or related field. Master's degree preferred.
  • In-depth knowledge of cGMP regulations, ICH guidelines, and other relevant quality standards.
  • Knowledge of AAV manufacturing process and clean room environment a plus.
  • Ability to make decisions and manage own and team priorities in alignment with department and site objectives.
  • Ability to present PQS, strategy and supporting data in a clear and understandable way during audits.
  • Demonstrated ability to think logically and evaluate complex situations to arrive at the true root cause.
  • Experience in using Root Cause Analysis Tools, Risk Management processes, Technical Writing and Microsoft Office applications.
  • Strong Team player, with focus on safety, quality, and timelines.
  • Ability to work in a fast-paced environment and to prioritise own and teamwork.
  • Ability to build strong relationships and collaborate effectively across departments.
  • Excellent Written & Oral Communication skills.


If you are interested in this opportunity, please apply directly or contact Hemish Ilangaratne at h.ilangaratne@rx-group.io for further information.