Qa Director Audit & Inspection Gcp-Cdcs

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Job overview:
Provides strategic direction and oversight of Quality Assurance Audit and Inspection operations and assures that audit program aligns with global RCQA strategies. Oversees external sponsor and inspectorate evaluations assuring follow up on trends or critical to quality findings identfied. Engages operational leaders in execution of quality strategies, while driving a strong culture of quality and compliance and continuous improvement.
Essential Job Duties:

• Is responsible for inspection preparation, conduct and response
  
• Ensures development, maintenance, and execution/delivery of fit-for-purpose/risk-based audit programs aligned with global RC&QA strategies and alignment with industry best practices and regulatory expectations
  
• Represents RC&QA as a senior leader as a key point of contact in various client meetings including but not limited to proposals and bid defences
  
• Propose and create appropriate organisational 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
  
• 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
  
• Perform other duties, as assigned by management
  

Required experience:

• 10+ 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 effectively lead teams through the management of people leaders at multiple sites or geographic locations
  
• Ability to provide consultation, guidance and influence to leaders of multidisciplinary teams to drive strategic business process improvement initiatives
  

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea 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.
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