Senior Director, Quality Assurance

1 month ago

Norcross, United States Biotech Partners Full time

Senior Director, Quality Assurance & Regulatory Affairs

Location: Norcross, GA (Hybrid)

Overview:

We're looking for a dynamic and goal-oriented individual to lead our Quality division. In this pivotal role, you'll oversee the site's Quality system, guiding the Quality Assurance, Quality Control, and Regulatory Affairs teams.

Your responsibilities will encompass the development, implementation, and maintenance of a site Quality Management System that aligns with US Federal Regulations, EU Regulation 2017/746, EN ISO 13485 standards, and our own Quality criteria for manufacturing, controlling, storing, and distributing products. As a key member of the site leadership team, you'll champion a culture of Quality and Compliance, advocating for 'Right First Time' and Continuous Improvement principles while overseeing the GMP aspects of plant operations.

You'll collaborate with senior management to establish and enforce policies, ensuring they meet both our internal standards and regulatory requirements. Your role is critical in deciding the acceptability and release of all products from the site. Your oversight will extend to Quality Assurance, Quality Control, and Regulatory Affairs documentation, as well as liaising with regulatory inspections and customer audits. Additionally, you'll manage the department's budget, staff recruitment, and development, and steer the overall management of the Quality and RA teams.

Key Responsibilities:

  • specialized knowledge and direction in understanding and applying government regulations, agency guidelines, and company policies to ensure adherence.
  • and enforces policies and procedures to comply with relevant laws and regulations, also overseeing the fulfillment of regulatory reporting obligations.
  • and maintains strategies for regulatory filings and market approvals, ensuring these align with product development and lifecycle management.
  • with the comprehensive monitoring and successful operation of specified functions, integrating these seamlessly with other key organizational units.
  • as the site's Management Representative and the Person Responsible for Regulatory Compliance (PRRC), as outlined by 21CFR part 820 and the In Vitro Diagnostic Regulation (IVDR) Regulation (EU) 2017/746.
  • the strategy for risk management and design controls in the creation and production of new and existing Medical Device products.
  • autonomously, steered by broad organizational policies and goals, making decisive choices that impact significant organizational components or functional activities.
  • that tasks, including regulatory filings, CAPAs, investigations, and various compliance-related activities, are completed within set timelines.
  • that employees within the relevant departments receive and document necessary training.
  • manages, and adheres to the budget for the designated departments.

Minimum Requirements & Experience:

  • of a Bachelor of Science degree or an equivalent qualification in a Science or Engineering discipline.
  • least 10 years of leadership experience encompassing responsibilities in Quality Assurance and Regulatory Affairs within the In Vitro Diagnostics (IVD), Medical Device, and/or Biopharmaceutical sectors.
  • track record of successfully navigating US FDA, EU, and Rest of World (ROW) pre-market audits/inspections and regulatory filings, including 510(k) submissions and IVDR/MDR compliance.
  • in developing processes and systems that adhere to Quality System Regulations (QSR), including 21CFR Parts 210, 211, 11, and 820, as well as ISO 13485 and ISO 14971 standards, with a particular focus on Corrective and Preventive Action (CAPA) Systems.

  • Senior Director, Quality Assurance

    1 month ago

    Norcross, United States Biotech Partners Full time

    Senior Director, Quality Assurance & Regulatory AffairsLocation: Norcross, GA (Hybrid)Overview:We're looking for a dynamic and goal-oriented individual to lead our Quality division. In this pivotal role, you'll oversee the site's Quality system, guiding the Quality Assurance, Quality Control, and Regulatory Affairs teams.Your responsibilities will encompass...

  • Quality Assurance

    1 month ago

    Norcross, United States ComSonics Full time

    Job DescriptionJob DescriptionAre you looking for a great place to work? Cable Connections, a division of ComSonics, Inc., is the place for you! We are looking for someone experienced in Quality Assurance who will be responsible for providing inspection of wire and cable assemblies to insure conformance of product to established guidelines.Qualified...

  • Quality Assurance

    2 months ago

    Norcross, United States ComSonics Full time

    Job DescriptionJob DescriptionAre you looking for a great place to work? Cable Connections, a division of ComSonics, Inc., is the place for you! We are looking for someone experienced in Quality Assurance who will be responsible for providing inspection of wire and cable assemblies to insure conformance of product to established guidelines.Qualified...

  • Quality Assurance

    1 week ago

    Norcross, United States ComSonics Full time

    Job DescriptionJob DescriptionAre you looking for a great place to work? Cable Connections, a division of ComSonics, Inc., is the place for you! We are looking for someone experienced in Quality Assurance who will be responsible for providing inspection of wire and cable assemblies to insure conformance of product to established guidelines.Qualified...

  • Manufacturing Quality Assurance Technician

    2 weeks ago

    Norcross, United States Immucor Full time

    Manufacturing Quality Assurance Technician Job Locations US-GA-Norcross Job ID 2024-3586 Category Quality Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis,...

  • Manufacturing Quality Assurance Technician

    2 weeks ago

    Norcross, United States Immucor Full time

    Manufacturing Quality Assurance TechnicianJob Locations US-GA-NorcrossJob ID 2024-3586Category QualityOverviewWerfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant....

  • Senior Quality Assurance Manager

    1 month ago

    Norcross, United States OFS Fitel Full time

    Job DescriptionJOB PURPOSE: The Quality Manager has the authority, independence and means to develop the Quality Management System and ensure the application of this standard throughout OFS Norcross. Actively communicate and participate in a continuous improvement culture providing recommendations and implementing enhancements to current methods, policies,...

  • Senior Quality Assurance Manager

    1 month ago

    Norcross, United States OFS Fitel Full time

    Job DescriptionJOB PURPOSE: The Quality Manager has the authority, independence and means to develop the Quality Management System and ensure the application of this standard throughout OFS Norcross. Actively communicate and participate in a continuous improvement culture providing recommendations and implementing enhancements to current methods, policies,...

  • Senior Quality Assurance Manager

    1 month ago

    Norcross, United States OFS Fitel Full time

    Job DescriptionJOB PURPOSE: The Quality Manager has the authority, independence and means to develop the Quality Management System and ensure the application of this standard throughout OFS Norcross. Actively communicate and participate in a continuous improvement culture providing recommendations and implementing enhancements to current methods, policies,...

  • Senior Nurse Consultant

    2 weeks ago

    Norcross, United States PruittHealth Full time

    JOB PURPOSE: Senior Nurse Consultant serves as a member of the clinical and region team, to assist centers in achieving clinical excellence. She/he is responsible for planning and directing clinical operations and quality improvement practices for designated centers. The senior nurse consultant provides education, mentoring and validation of required...

  • Quality Consultant RN

    4 weeks ago

    Norcross, GA, United States PruittHealth Full time

    Senior Nurse Consultant serves as a member of the clinical and region team, to assist centers in achieving clinical excellence. She/he is responsible for planning and directing clinical operations and quality improvement practices for designated centers.The senior nurse consultant provides education, mentoring and validation of required systems and processes...

  • Assistant Director of Nursing

    3 weeks ago

    Norcross, United States The Mansions at Sandy Springs Full time

    We are excited to announce that The Mansions at Sandy Springs is now a part of the AgeWell Solvere Living family!As a certified Great Place to Work for 6 years in a row, AgeWell Solvere Living proudly offers:Medical, Dental and Vision benefitsCompany-paid Life Insurance and Voluntary DisabilityPaid Time off and Holidays401(k) Retirement Savings Plan At...

  • Assistant Director of Nursing

    3 weeks ago

    Norcross, United States The Mansions at Alpharetta Full time

    We are excited to announce that The Mansions at Sandy Springs is now a part of the AgeWell Solvere Living family! As a certified Great Place to Work for 6 years in a row, AgeWell Solvere Living proudly offers: Medical, Dental and Vision benefits Company-paid Life Insurance and Voluntary Disability Paid Time off and Holidays 401(k) Retirement...

  • Quality Assurance Utilization Coordinator

    1 month ago

    Norcross, United States GeorgiaGov Full time

    APEX Program is an innovative program that has been providing services to the students in the state of Georgia, supported by Georgia Department of Behavioral Health and Developmental Disabilities (DBHDD), and school systems. Under general supervision, compiles reports of indicators pertaining to potential fraud. Reviews system reports to determine state or...

  • Quality Systems Management Associate

    1 month ago

    Norcross, United States Ole' Mexican Foods, Inc Full time

    At Ole, our mission is to produce the finest Authentic Mexican inspired products with an unwavering commitment to quality and freshness. We believe that holding a seat at your dinner table is the ultimate compliment, and we strive to help families create wholesome, fun, and authentic eating experiences. Job Summary: As a QA Systems Management Associate at...

  • Quality Systems Management Associate

    1 month ago

    Norcross, United States Ole Mexican Foods, INC Full time

    Job DescriptionJob DescriptionAt Ole, our mission is to produce the finest Authentic Mexican inspired products with an unwavering commitment to quality and freshness. We believe that holding a seat at your dinner table is the ultimate compliment, and we strive to help families create wholesome, fun, and authentic eating experiences.Job Summary:As a QA...

  • Director of Ethics Fellowship

    2 weeks ago

    Norcross, United States Wellstar Health System, Inc. Full time

    Facility: 1800 Parkway Center Job Summary: The Director of Clinical Ethics Fellowship is an active member of the ethics program at Wellstar Health System overseeing the nationally recognized clinical ethics fellowship program at Wellstar Health System. The Director oversees the individual clinical ethics fellows and continues to build the program and...

  • Warehouse Quality Assistant

    1 month ago

    Norcross, United States ALLESET INC Full time

    Job DescriptionJob DescriptionFrom our corporate headquarters near Atlanta, Georgia to operations in eight countries (the Dominican Republic, China, Hong Kong, Vietnam, India, the Netherlands, UK, USA), GRI-Alleset is a privately held company which focuses on the design, development and manufacturing of disposable medical supplies. We pride ourselves on...

  • Senior Business Operations Leader

    4 weeks ago

    Norcross, United States Wabtec Corporation Full time

    Job DescriptionWho will you be working with?The purpose of the Logistics, KinetiX and Digital Mine Operations Leader is to drive operational excellence and to leverage tools and processes to make information gathering and decision-making more effective. The Operations Leader will collaborate with all functions across multiple business units, including...

  • Senior Business Operations Leader

    4 weeks ago

    Norcross, United States Wabtec Corporation Full time

    Job DescriptionWho will you be working with?The purpose of the Logistics, KinetiX and Digital Mine Operations Leader is to drive operational excellence and to leverage tools and processes to make information gathering and decision-making more effective. The Operations Leader will collaborate with all functions across multiple business units, including...