QA Director, GCP-CLS
Get ready to redefine what's possible and discover yourextraordinarypotential. Here at Labcorp Drug Development, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support ofexceptionalpeoplefrom across the globe and anenergized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients-and your career.
We are seeking a dynamic QA director to support GCP & CLS.
** Preference will be given to those candidates who are willing to locate to Indianapolis, IN however, for the right candidate we can consider a remote opportunity .**
For this role, the ideal candiate will:
- Develop and effectively communicate CLS regulatory strategies to both internal and external stakeholders
- Lead successful CLS regulatory change management initiatives.
- Propose and create appropriate organizational metrics/dashboards demonstrating quality and compliance
- Be the solutions partner to operational leaders driving business strategies, a strong culture of quality and compliance and continuous improvement
- 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
- Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
- Partner with appropriate internal stakeholders to set and manage the functional budget
- Act as the RC&QA Leadership Team's delegate
- Represent Covance in external associations/forums/organizations, as an industry SME
- Must be willing to travel monthly.
- A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
- Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable
- Experience may be substituted for education
- 16 years in regulatory environment (experience in GXP roles)
- Experience & regulatory expertise of industry quality systems/standards
- Ability to effectively communicate functional strategy with external parties
- Ability to distill critical information
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