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QA Associate Director, Regulatory Intelligence

2 months ago

Huntingdon Cambridgeshire United Kingdom Labcorp Full time

Do you have experience working in a GxP regulatory environment paired with technical knowledge and understanding of global regulatory intelligence and compliance?

Are you looking for a diverse and engaging role with opportunity to grow?

Do you want to work for a world-leading life science organization with a mission to improve health and lives?

If so, read on

Recognized as one of Forbes’ World’s Best Employers and named one of The World’s Most Admired Companies 2024 by Fortune, here at Labcorp, we are seeking a QA Associate Director, Regulatory Intelligence to join our Central Labs Services (CLS) quality team. 

The QA 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 position is remote based.

In this individual contributor role you will:

  • Support and drive activities to ensure appropriate regulatory intelligence and compliance information is maintained and made available across the company

  • Provide regulatory intelligence to the organization, identifying 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

  • Provide appropriate regulatory compliance information, advice, support and training to project teams and clients, proactively communicating important changes and their potential impact

  • Contribute 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

We can offer you:

  • Competitive salary and benefits package

  • Considerable interaction with internal and external stakeholders including clients and regulatory bodies

  • Diverse and engaging work with exposure to multiple different regulations and groups within the business

  • Opportunity to develop your network and profile in the industry

  • Continuous growth with our learning-based and knowledge sharing culture so you’ll know how to expertly respond and adapt as the industry and regulations continue to evolve

  • Global experience

  • Remote working

Education / Qualifications:

  • A minimum of Bachelor’s degree in Life Sciences (Or equivalent Life Science experience)

  • Experience may be substituted for education

Skills / Experience:

  • Significant demonstrable experience (circa 10 years) working in a regulatory environment to GxP

  • Demonstrated technical knowledge and understanding of global regulatory intelligence and compliance

  • Experience applying GxP requirements to the conduct of drug development

  • Effective planning, organizational, and problem solving skills

  • Proven ability to deliver consistent project team performance and strategic process improvement initiatives

  • Ability to lead and encourage team building, influencing and conflict resolution

  • Proven written, verbal, interpersonal and change management skills

  • Experience in the areas of Regulatory Intelligence, project management & implementation, compliance, and process improvement

  • Aptitude to mentor more junior members within the team and organization

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to embrace possibilities and change lives

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 apply. If 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.

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