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QA Director Audit

4 months ago

Leeds England, United Kingdom Fortrea Full time
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.

Find out if this opportunity is a good fit by reading all of the information that follows below.

Job overview:
Provides strategic direction and oversight of Quality Assurance GCP 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.