Director, Regulatory Intelligence
Il y a 2 mois
**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 leadership responsibilities?**
**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 Director, Regulatory Intelligence **to join our Central Labs Services (CLS) quality team.
The QA Director, Regulatory Intelligence provides leadership for the Regulatory Intelligence Office partnering with internal stakeholders to ensure compliance to appropriate quality standards across a global business unit or Drug Development.
**This position is remote based and holds three direct reports**
**In this role you will**:
- Develop and effectively communicate the Regulatory Intelligence Office strategies to the team and internal stakeholders
- Partner with operational leaders helping to drive business strategies by ensuring that the Regulatory Intelligence Office is an enabler for business success
- Propose and create appropriate organizational metrics/dashboards demonstrating quality and compliance
- Communicate escalation issues to management in a timely manner implementing appropriate functional and business solutions and providing regular update
- Negotiate, influence and effectively manage constructive crucial conversations with business partners and external stakeholders
- Partner with operational leaders to ensure stakeholder buy-in, resources available and multidisciplinary team in place to drive strategic business process improvement initiatives
- Ensure appropriate interpretation of applicable quality regulations/standards and ensure appropriate policies and procedures are revised/created
- Develop resource strategies to support the functional needs and ensure recruitment, training etc. is aligned to the strategy
- Mentor RC&QA and operational resources, to drive a quality culture
- Partner with appropriate internal stakeholders to set and manage the functional budget
- Represent Labcorp in external associations/forums/organizations, as an industry SME
**We can offer you**:
- Competitive salary and benefits package
- The opportunity to lead a new but very knowledgeable and experienced team
- 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
- A strategic role with global focus and exposure
- Remote working
**Education / Qualifications**:
- A minimum of Bachelor’s degree in Life Sciences (Or equivalent Life Science experience)
- Postgraduate degree (MSC or equivalent) in science or management related discipline preferable
**Skills / Experience**:
- Demonstrable experience leading a team and significant experience working in a regulatory environment to GxP (circa 16 years)
- Demonstrated technical knowledge and understanding of global regulatory intelligence and compliance
- Competent in effectively communicating functional strategy with external parties
- Capable of effectively leading teams through the management of people leaders at multiple sites or geographic locations
- Ability to distill critical information
- Adept at providing consultation, guidance and influence to leaders of multidisciplinary teams to drive strategic business process improvement initiatives
- Effective planning, organizational, and problem solving skills
- Proven written, verbal, interpersonal and change management skills
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,
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