Associate Director

5 days ago

Durham, North Carolina, United States BioSpace, Inc. Full time
Job Summary

We are seeking an experienced Associate Director to lead our Quality Assurance team in the Device Assembly and Packaging (DAP) production area. The successful candidate will be responsible for building a strong quality culture, leading the QA team, and ensuring compliance with area procedures and controls for labeling and packaging operations.

Key Responsibilities
  • Develop and implement quality strategies to ensure a safe work environment and compliance with regulatory requirements.
  • Lead the QA team to achieve operational excellence and ensure effective communication with cross-functional teams.
  • Collaborate with the production and design organization to ensure 24/7 Quality oversight and support.
  • Review and approve GMP documentation, including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, etc.
  • Partner with Associate Director for Device Assembly to set cohesive QA organization and operation to support DAP.
  • Support the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in DAP.
Requirements
  • Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study.
  • 7 years of experience working in the pharmaceutical industry in QA/QC roles.
Preferred Qualifications
  • Previous facility or area start-up experience.
  • Previous equipment qualification and process validation experience.
  • Previous experience with SAP or other inventory management systems.
  • Previous experience with highly automated combination products, packaging, and warehouse operations.
  • Previous experience with Manufacturing Execution Systems and electronic batch release.
  • Previous experience with automated material movement (central palletizing operation, automated warehousing).
  • CQM, CQE, or CQA certification from the American Society for Quality (ASQ).
  • Previous experience with deviation and change management systems including Trackwise and Veeva.
  • Previous management or leadership experience including leading or working effectively with a cross-functional group.
  • Strong knowledge of Quality Management Systems and applicable regulatory requirements.
  • Previous experience directly supporting a pharmaceutical manufacturing operation.
  • Excellent interpersonal, written, and oral communication skills.
  • Strong technical aptitude and ability to train and mentor others.
About Lilly

Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. We are committed to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

  • Associate Director of Annual Giving

    2 weeks ago

    Durham, North Carolina, United States North Carolina Central University Full time

    Associate Director of Annual GivingNorth Carolina Central University is seeking a skilled fundraiser to fill the role of Associate Director of Annual Giving. This entry-level position will operate under the leadership of the Director of Annual Giving, focusing on developing and implementing strategies to secure donations from alumni, friends, and other...

  • Associate Director

    5 days ago

    Durham, North Carolina, United States BioSpace, Inc. Full time

    Job Title: Associate Director - Quality AssuranceAt BioSpace, Inc., we are committed to delivering high-quality products and services to our customers. We are seeking an experienced Associate Director - Quality Assurance to join our team.Job Summary:The Associate Director - Quality Assurance will be responsible for leading the quality assurance team in...

  • Associate Director of Annual Giving

    4 weeks ago

    Durham, North Carolina, United States North Carolina Central University Full time

    Job Title: Associate Director of Annual GivingNorth Carolina Central University is seeking a highly skilled and motivated individual to join our team as an Associate Director of Annual Giving. This is an exciting opportunity to make a meaningful impact on the university's fundraising efforts and contribute to the success of our students and faculty.Job...

  • Lifestyle Director

    4 weeks ago

    Durham, North Carolina, United States Associa Full time

    Associa: A Leader in Community Association ManagementCome work at Associa, an industry leader in community association management. We are seeking a Lifestyle Director to join our team.About the RoleThe Lifestyle Director will be responsible for overseeing the operations of our community associations, ensuring that our residents receive exceptional service...

  • Associate Director of Manufacturing Operations

    5 days ago

    Durham, North Carolina, United States Beam Therapeutics Inc. Full time

    Job Title: Associate Director, ManufacturingCompany Overview:Beam Therapeutics Inc. is a pioneering company in the field of precision genetic medicines. Our mission is to establish a leading platform for gene editing and delivery technologies, and we are committed to building internal manufacturing capabilities to support our growth.Position Overview:The...

  • Associate Director, Preclinical Development

    5 days ago

    Durham, North Carolina, United States BioSpace, Inc. Full time

    Job Title: Associate Director, Preclinical DevelopmentWe are seeking an experienced Associate Director to lead our preclinical development activities for gene editing therapeutic programs. The successful candidate will have a strong background in preclinical development, with expertise in pharmacology, immunology, and safety.Key Responsibilities:Develop and...

  • Associate Director

    4 days ago

    Durham, North Carolina, United States BioSpace, Inc. Full time

    Job DetailsLilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We are headquartered in Indianapolis, Indiana, and our employees work together to discover and bring life-changing medicines to those who need them.We are looking for a talented individual to join our team as an Associate Director...

  • Associate Director of Quality Control

    5 days ago

    Durham, North Carolina, United States BioSpace, Inc. Full time

    Job Title: Associate Director of Quality ControlAt BioSpace, Inc., we are committed to delivering high-quality products and services to our customers. We are seeking an experienced Associate Director of Quality Control to lead our quality control team and ensure that our products meet the highest standards of quality.Responsibilities:Lead the quality control...

  • Associate Director, Preclinical Development

    4 days ago

    Durham, North Carolina, United States Life Edit Therapeutics Full time

    Job Title:Associate Director, Preclinical DevelopmentJob Summary:We are seeking an experienced Associate Director, Preclinical Development to lead our preclinical development activities for gene editing therapeutic programs. The successful candidate will have a strong background in preclinical development, excellent organizational and communication skills,...

  • Associate Director of Operations and Strategy

    3 weeks ago

    Durham, North Carolina, United States InsideHigherEd Full time

    Job Summary:The Associate Director of Operations, Marketing & Communications plays a crucial leadership role within the MarComms team at Duke University. This role is responsible for enhancing operational efficiency, managing key projects, and implementing and managing the new project manager tool. The Associate Director will oversee the Communications...

  • Associate Director

    5 days ago

    Durham, North Carolina, United States BioSpace, Inc. Full time

    Job DetailsLilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We are headquartered in Indianapolis, Indiana, and our employees work together to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...

  • Associate Director of Annual Giving

    4 days ago

    Durham, North Carolina, United States North Carolina Central University Full time

    Job Title: Associate Director of Annual GivingNorth Carolina Central University is seeking a highly skilled and experienced Associate Director of Annual Giving to join our team. As a key member of our Development team, you will be responsible for managing and overseeing annual giving programs, including direct mail, phonathon, class reunion giving,...

  • Associate Director of Undergraduate Engagement

    4 days ago

    Durham, North Carolina, United States Duke University Full time

    Job Summary:The Associate Director of Undergraduate Engagement will play a key role in developing and implementing curricular and co-curricular programs in ethics across the undergraduate experience at Duke University. This position will work closely with the Institute leadership to design and implement programs that connect with the new curriculum launching...

  • Associate Director, Finance

    2 weeks ago

    Durham, North Carolina, United States FHI 360 Full time

    Job SummaryThe Associate Director, Finance is a key leadership position responsible for developing and maintaining sound financial management systems in line with USAID and other donor rules and regulations, as well as local laws. This role requires a comprehensive understanding of accounting, financial controls, and financial information systems.Key...

  • Associate Director for Campus Office Operations

    2 weeks ago

    Durham, North Carolina, United States Duke University Full time

    Job Title: Associate Director for Campus Office OperationsDuke University is seeking a highly skilled and experienced Associate Director for Campus Office Operations to join our team. This is a key leadership role that will oversee the day-to-day operations of our campus offices, ensuring that our students receive exceptional service and support.Key...

  • Associate Director, Workforce Programs

    5 days ago

    Durham, North Carolina, United States FHI 360 Full time

    Job Summary:As Associate Director, Workforce Programs, you will lead the development and implementation of workforce projects, managing a team to ensure strategic coherence and compliance with funder regulations. You will work closely with the Director of Learning and Workforce Development to provide guidance and oversight, building the capacities of project...

  • Associate Director, TRIO Upward Bound Program

    2 weeks ago

    Durham, North Carolina, United States University System Of New Hampshire Full time

    Job SummaryWe are seeking an experienced and dedicated Associate Director to join our team at the University System of New Hampshire. The successful candidate will be responsible for providing academic, career, and college counseling to eligible students, as well as developing and coordinating the academic year program, including monthly Saturday Academies,...

  • Associate Director of Quality Operations

    5 days ago

    Durham, North Carolina, United States Jobot Full time

    Job Title: Associate Director, Quality OperationsWe are seeking an experienced Associate Director of Quality Operations to join our team at Jobot. As a key member of our Quality Operations team, you will be responsible for providing laboratory QA support for our biologics commercial and clinical development programs.Key Responsibilities:Provide laboratory QA...

  • HR Knowledge Manager Associate Director

    4 days ago

    Durham, North Carolina, United States Hispanic Technology Executive Council Full time

    About the RoleWe are seeking a highly skilled Knowledge Manager Associate Director to join our team at Kyndryl. As a key member of our HR team, you will be responsible for executing our HR content strategy, with a focus on our ServiceNow HRSD knowledge base.Your primary objective will be to ensure that our knowledge base remains current, accurate, relevant,...

  • Associate Annual Giving Director, Athletics

    4 weeks ago

    Durham, North Carolina, United States University System Of New Hampshire Full time

    About the RoleWe are seeking an experienced and skilled Associate Annual Giving Director to join our team at the University of New Hampshire. As a key member of our Athletics department, you will be responsible for developing and implementing an annual giving strategy that aligns with the Athletic Director's vision and priorities.Key ResponsibilitiesPartner...