5,064 Qa Management jobs in the United States

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Role Description

Responsible for implementing and maintaining the Procedures and Document Management process. Includes Good Manufacturing Practice (GMP) library, document inventory, ensuring true copy accuracy, and overseeing document control within our electronic document system. This role also involves developing and delivering training content and providing leadership within the QA team.

Key Responsibilities:

• Leadership: Provide guidance and support to the QA Procedures team, fostering a culture of compliance and continuous improvement. This position includes some supervisory responsibilities.
• Document Control: Manage document control processes within the electronic document system, ensuring timely updates and compliance with SOPs. Monitor and follow up on documents in the review and approval cycle to ensure timely progression. Monitor and follow up on documents in the review and approval cycle to ensure timely progression.
• Document Inventory Management: Oversees the inventory of all QA documents, ensuring accurate tracking and availability. Monitor and follow up on documents in the review and approval cycle to ensure timely progression.
• GMP Library Maintenance: Implement and ensure the GMP library is up-to-date and accessible, including the organization and archiving of documents.
• True Copy Verification: Ensure all documents are true copies, maintaining integrity and compliance with regulatory standards.
• SOP Content Creation: Develop and update SOPs related to GMP Library processes, ensuring clarity, compliance, and alignment with regulatory requirements.
• Training Content Development and Delivery: Create and deliver training materials to staff, ensuring understanding and adherence to QA processes and regulations.

• Bachelor's degree in a related field (e.g., Life Sciences, Quality Assurance, Regulatory Affairs).
• 3+ years of experience in a QA compliance role, preferably within a GMP-regulated environment.

• Strong knowledge of GMP regulations and document control processes.
• Experience with electronic document management systems.
• Excellent organizational and communication skills.
• Proven ability to develop and deliver effective training programs.
• Leadership experience and the ability to work collaboratively within a team.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Proficiency in document management systems and software.
• Attention to detail and ability to work independently

• Leadership: Provide guidance and support to the QA Procedures team, fostering a culture of compliance and continuous improvement. This position includes some supervisory responsibilities.
• Document Control: Manage document control processes within the electronic document system, ensuring timely updates and compliance with SOPs. Monitor and follow up on documents in the review and approval cycle to ensure timely progression. Monitor and follow up on documents in the review and approval cycle to ensure timely progression.
• Document Inventory Management: Oversees the inventory of all QA documents, ensuring accurate tracking and availability. Monitor and follow up on documents in the review and approval cycle to ensure timely progression.
• GMP Library Maintenance: Implement and ensure the GMP library is up-to-date and accessible, including the organization and archiving of documents.
• True Copy Verification: Ensure all documents are true copies, maintaining integrity and compliance with regulatory standards.
• SOP Content Creation: Develop and update SOPs related to GMP Library processes, ensuring clarity, compliance, and alignment with regulatory requirements.
• Training Content Development and Delivery: Create and deliver training materials to staff, ensuring understanding and adherence to QA processes and regulations.

• Bachelor's degree in a related field (e.g., Life Sciences, Quality Assurance, Regulatory Affairs).
• 3+ years of experience in a QA compliance role, preferably within a GMP-regulated environment.

• Strong knowledge of GMP regulations and document control processes.
• Experience with electronic document management systems.
• Excellent organizational and communication skills.
• Proven ability to develop and deliver effective training programs.
• Leadership experience and the ability to work collaboratively within a team.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Proficiency in document management systems and software.
• Attention to detail and ability to work independently

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. Role DescriptionResponsible for implementing and maintaining the Procedures and Document Management process. Includes Good Manufacturing Practice (GMP) library, document inventory, ensuring true copy accuracy, and overseeing document control within our electronic document system. This role also involves developing and delivering training content and providing leadership within the QA team.Key Responsibilities:Leadership: Provide guidance and support to the QA Procedures team, fostering a culture of compliance and continuous improvement. This position includes some supervisory responsibilities.Document Control: Manage document control processes within the electronic document system, ensuring timely updates and compliance with SOPs. Monitor and follow up on documents in the review and approval cycle to ensure timely progression. Monitor and follow up on documents in the review and approval cycle to ensure timely progression.Document Inventory Management: Oversees the inventory of all QA documents, ensuring accurate tracking and availability. Monitor and follow up on documents in the review and approval cycle to ensure timely progression.GMP Library Maintenance: Implement and ensure the GMP library is up-to-date and accessible, including the organization and archiving of documents.True Copy Verification: Ensure all documents are true copies, maintaining integrity and compliance with regulatory standards.SOP Content Creation: Develop and update SOPs related to GMP Library processes, ensuring clarity, compliance, and alignment with regulatory requirements.Training Content Development and Delivery: Create and deliver training materials to staff, ensuring understanding and adherence to QA processes and regulations.Basic Qualifications:Bachelor's degree in a related field (e.g., Life Sciences, Quality Assurance, Regulatory Affairs).3+ years of experience in a QA compliance role, preferably within a GMP-regulated environment.Additional Preferences: Strong knowledge of GMP regulations and document control processes.Experience with electronic document management systems.Excellent organizational and communication skills.Proven ability to develop and deliver effective training programs.Leadership experience and the ability to work collaboratively within a team.Strong organizational and time management skills.Excellent communication and interpersonal skills.Proficiency in document management systems and software.Attention to detail and ability to work independentlyLilly is dedicated 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. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is$63,000 - $162,800Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.#WeAreLilly

5 months ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Responsibilities Be a key developer in expanding our Quality & Regulatory Risk Management team for our Sleep and Respiratory Care organization. Create and implement new tools and methods to manage risk, contributing to the safety and efficacy of medical products that save lives and improve health. Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management. Lead cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File. Facilitate the creation of risk management tools, assessments, processes, and principles, including FMEAs. Analyze existing similar products from the company and competitors to provide documented compliance and evidence of State of the Art for periodic risk management updates. Ensure products meet regulatory requirements such as FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures. Convert customer requirements into product specifications and post-market surveillance codes systematically and logically. Develop and improve procedures and work instructions to ensure reliable, repeatable results, supporting compliance initiatives including CAPAs across the Connected Care business groups. Contribute to the organization’s mission to develop innovative health technologies that positively impact billions of lives annually. Lead teams, drive projects, think strategically, and inspire colleagues worldwide in alignment with Philips' mission to improve lives through innovation. Requirements BS in Engineering or a related field; MS preferred. 6+ years of experience in Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related fields in a highly regulated industry. 2+ years' experience with an MS or higher degree. Hands-on experience with the ISO 14971 standard. Knowledge of standards such as 21 CFR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304. Strong understanding of risk management tools, methodologies, and processes. Experience managing complex projects and implementing cultural change. Excellent interpersonal and presentation skills. Experience within a Quality Management System. Green Belt or Black Belt certification preferred. Strong teamwork skills and stakeholder influence abilities. Seniority level Mid-Senior level Employment type Contract Job function Engineering and Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr

Title: QA Analyst- Release Management

Location: Washington, DC

Duration: 6+ Months

Responsibilities:

•Coordinate builds and testing of releases

•Coordinate the scheduling and roll out of releases

•Provide communication and information, including relevant

release documentation, as required.

•Ensure appropriate checkpoints are met and coordinate release

sign off.

•Coordinate the implementation of the release

•Complete post implementation reviews

•Maintain quality checks on releases and record those that directly

or indirectly cause support Incidents

Overall, we are looking to onboard a candidates with solid Release Management experience, with great analytical skill as well as a keen eye for quality

Requirement

•Strong attention to detail, coordination, and communication skills

•Must have hands on experience with a TPF system

•Must be well versed in Schedule Management

•Capable to deliver a comprehensive assessment of current state of project's release statuses

•Previous exposure to ITIL release, service management and/or project management.

•Ability to work to tight deadlines and handle work pressures to successfully deliver releases.

•Experience of working across different business areas, demonstrating customer focus and good corporate awareness.

•Service Now experience extremely desirable

•Involvement in design and implementation of policy, process and procedure

•Demonstrable ability of being able to communicate across departments at all levels and with senior management, including directors.

Soft Skills

•Minimal supervision

•Resolution and recommendation

•Motivated

•Organized

•Team Player

Title: QA Analyst - Release Management Location: Washington, DC Duration: 6+ Months Responsibilities: Coordinate builds and testing of releases Coordinate the scheduling and rollout of releases Provide communication and information, including relevant release documentation, as required Ensure appropriate checkpoints are met and coordinate release sign-off Coordinate the implementation of the release Complete post-implementation reviews Maintain quality checks on releases and record those that directly or indirectly cause support incidents Overall, we are looking to onboard candidates with solid Release Management experience, great analytical skills, and a keen eye for quality. Requirements: Strong attention to detail, coordination, and communication skills Hands-on experience with a TPF system Well-versed in Schedule Management Ability to assess the current state of project's release statuses comprehensively Previous exposure to ITIL release, service management, and/or project management Ability to work under tight deadlines and handle work pressures effectively Experience working across different business areas with a customer focus and good corporate awareness Experience with ServiceNow is highly desirable Involvement in designing and implementing policy, process, and procedures Strong communication skills across departments and with senior management, including directors Soft Skills: Ability to work with minimal supervision Problem resolution and recommendations Motivated and organized Team player #J-18808-Ljbffr