Laboratory Corporation
QA Associate Director, Regulatory Intelligence
Laboratory Corporation, Indianapolis, Indiana, us, 46262
Join the Quality Department as a
Quality Associate Director of Regulatory Intelligence !Do you have strong experience in Regulatory Intelligence for a life science company? Do you have knowledge of LDT and IVDR?
Apply now!The Quality Associate Director Regulatory Intelligence
monitors the environment for regulatory compliance intelligence in the company's areas of interest to ensure that current awareness is maintained across the organization and, where necessary, that company procedures are introduced or adapted to respond to changes in the regulatory environment.This is an exciting new position at Labcorp!!! Be a part of an exceptional Quality Team!Supports and drives activities to ensure appropriate regulatory intelligence and compliance information is maintained and made available across the company.
Provides regulatory intelligence to the organization, identifies potential compliance issues in a timely manner, and ensures they are reported to the appropriate levels of management to achieve satisfactory resolution for the business.
Develop targeted summary documents, internal guidance, position papers, training materials and communications to ensure leadership and staff are informed on regulatory compliance information, risks and trends, and how existing procedures might need to be amended to remain in compliance.
Provides appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact.
Contributes towards the promotion of LabCorp regulatory compliance expertise, both internally and externally, by collaborating with colleagues and project teams members in support of Labcorp's mission, contributing to conference presentations and journal publications, and active participation in appropriate professional bodies.
Research and evaluate compliance risks and possible solutions, provide appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact.
Promote regulatory compliance expertise, both externally and internally, by collaborating with colleagues and project teams in support of Labcorp presentations and journal publications, and actively participating in appropriate professional bodies and regulatory forums.
Support client-facing staff by proactively providing advice on complex regulatory compliance issues.
Interact directly with clients on compliance issues that are escalated from project teams.
Support Regulatory Intelligence and Compliance in proposal discussions and bid defenses.
Support regulatory authority inspections at Labcorp facilities
Minimum Required:10 years in regulatory environment (experience in GXP roles)*
Strong knowledge of Regulatory Affairs and years of experience in a Regulatory Intelligence position*
Demonstrated technical knowledge and understanding of global regulatory intelligence and
compliance.
Experience applying GxP requirements to the conduct of drug development.
Setting priorities for the team about effective planning, organizational, and problem solving
skills.
Proven ability to deliver consistent project team performance and strategic process
improvement initiatives.
Lead and encourage team building, influencing and conflict resolution.
Proven written, verbal, interpersonal and change management skills.
Previous experience working in regulated environments, with regulatory agencies, and with a
variety of disciplines (GxPs)
Proven experience in the areas of Regulatory Intelligence, project management &
implementation, compliance, and process improvement.
Mentor more junior members within the team and organization.
Education/Qualifications/Certifications and Licenses:A minimum of Bachelor’s degree in Life Sciences (Or equivalent Life Science experience)*
Experience may be substituted for education
Application Window: November 10th, 2024Pay Range: $120,000 to $140,000/annuallyAll job offers will bebased on a candidate’s skills and prior relevant experience, applicabledegrees/certifications,as well as internal equity and market data.Position: This position can be Remote with time in Laboratory and travel 25%.Benefits:
Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here
.Labcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.We encourage all to applyIf you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility
.Formore information about how we collect and store your personal data, please see our Privacy Statement .
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Quality Associate Director of Regulatory Intelligence !Do you have strong experience in Regulatory Intelligence for a life science company? Do you have knowledge of LDT and IVDR?
Apply now!The Quality Associate Director Regulatory Intelligence
monitors the environment for regulatory compliance intelligence in the company's areas of interest to ensure that current awareness is maintained across the organization and, where necessary, that company procedures are introduced or adapted to respond to changes in the regulatory environment.This is an exciting new position at Labcorp!!! Be a part of an exceptional Quality Team!Supports and drives activities to ensure appropriate regulatory intelligence and compliance information is maintained and made available across the company.
Provides regulatory intelligence to the organization, identifies potential compliance issues in a timely manner, and ensures they are reported to the appropriate levels of management to achieve satisfactory resolution for the business.
Develop targeted summary documents, internal guidance, position papers, training materials and communications to ensure leadership and staff are informed on regulatory compliance information, risks and trends, and how existing procedures might need to be amended to remain in compliance.
Provides appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact.
Contributes towards the promotion of LabCorp regulatory compliance expertise, both internally and externally, by collaborating with colleagues and project teams members in support of Labcorp's mission, contributing to conference presentations and journal publications, and active participation in appropriate professional bodies.
Research and evaluate compliance risks and possible solutions, provide appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact.
Promote regulatory compliance expertise, both externally and internally, by collaborating with colleagues and project teams in support of Labcorp presentations and journal publications, and actively participating in appropriate professional bodies and regulatory forums.
Support client-facing staff by proactively providing advice on complex regulatory compliance issues.
Interact directly with clients on compliance issues that are escalated from project teams.
Support Regulatory Intelligence and Compliance in proposal discussions and bid defenses.
Support regulatory authority inspections at Labcorp facilities
Minimum Required:10 years in regulatory environment (experience in GXP roles)*
Strong knowledge of Regulatory Affairs and years of experience in a Regulatory Intelligence position*
Demonstrated technical knowledge and understanding of global regulatory intelligence and
compliance.
Experience applying GxP requirements to the conduct of drug development.
Setting priorities for the team about effective planning, organizational, and problem solving
skills.
Proven ability to deliver consistent project team performance and strategic process
improvement initiatives.
Lead and encourage team building, influencing and conflict resolution.
Proven written, verbal, interpersonal and change management skills.
Previous experience working in regulated environments, with regulatory agencies, and with a
variety of disciplines (GxPs)
Proven experience in the areas of Regulatory Intelligence, project management &
implementation, compliance, and process improvement.
Mentor more junior members within the team and organization.
Education/Qualifications/Certifications and Licenses:A minimum of Bachelor’s degree in Life Sciences (Or equivalent Life Science experience)*
Experience may be substituted for education
Application Window: November 10th, 2024Pay Range: $120,000 to $140,000/annuallyAll job offers will bebased on a candidate’s skills and prior relevant experience, applicabledegrees/certifications,as well as internal equity and market data.Position: This position can be Remote with time in Laboratory and travel 25%.Benefits:
Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here
.Labcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.We encourage all to applyIf you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility
.Formore information about how we collect and store your personal data, please see our Privacy Statement .
#J-18808-Ljbffr