Manager, QA Technology

Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.Job Summary:The Manager, QA Technology provides Quality and compliance leadership for the installation, change, validation, and support of key Quality systems including our electronic Quality Management System (eQMS) and our Laboratory Information Management System (LIMS). The Manager, QA Technology supports and executes company directives, policies, processes, and procedures in support of this objective and creates and tracks metrics to assure that all internal, client, and regulatory requirements are met. Additionally helps to resolve any quality issues that create bottlenecks or pain points or have the potential to negatively impact patient safety or product quality, which may entail managing and successfully addressing complex problems or developing and implementing robust preventive or corrective actions to enhance workflows.Responsibilities:Train, develop, and mentor a team of Quality Technology specialists

Confirm that all electronic systems are cGMP compliant

Ensure that all electronic quality systems and workflows are maintained in a validated state

Act as the quality review for the electronic systems validations to ensure user requirements, protocols, etc., are appropriately completed and addressed prior to release of systems

Manage risk mitigation when systems and/or processes are identified as requiring or benefiting from improvement

Work with suppliers to resolve issues or inquiries supporting and/or related to quality technology systems

Collaborate with internal partners in other parts of Quality Assurance (QA), Quality Control (QC), Technical Operations, Manufacturing, Materials Management, Facilities, and Project Management to resolve issues

Resolve issues, concerns, and inquiries from internal and external clients in order to ensure they system is functioning as needed for all users

Seek opportunities to improve Quality processes to improve compliance and create efficiencies

Represent the Quality release team during meetings and kaizen events

Interact with software vendors in order to increase our knowledge and internal support of all Quality related software systems

Qualifications:B.S. required, in a life science related field is preferred, or equivalent work experience

2 years in a lead, supervisory or managerial position

At least 4 years of relevant experience in a quality position, required

Direct experience with eQMS (e.g. TrackWise, Pilgrim, MasterControl, etc.) and LIMS (e.g. Novatech, LabVantage, etc.) packages

Experience in process understanding as it pertains to cGMP manufacturing and QA release

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be fully vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.