Auditor - GCP

BioSpace; King of Prussia (PA); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

CSL Behring is seeking a GCP Auditor to execute the global audit plan, ensuring data integrity and compliance with legal and corporate standards. You will audit clinical sites, CROs, and internal trial processes to identify non-compliance trends and drive corrective actions for long-term system stability.

The role requires 3+ years in QA within a GCP framework, strong communication with multinational teams, and up-to-date knowledge of ICH E6(R3) and CFR guidelines.

Qualifikationen

• Academic background: BS degree in a relevant biological science, science, or related discipline.
• Professional experience: 3+ years of Quality Assurance experience within a GCP-regulated environment, demonstrating understanding of clinical trial phases, monitoring, and regulatory frameworks.
• Audit expertise: Experience in clinical audit and inspection management, with understanding of QA requirements in clinical research.
• Communication skills: Excellent interpersonal and negotiation skills for multinational teams.
• Working knowledge of: ICH E6 (R3) Guideline.
• Familiarity with 21 CFR Part 11, Part 50, Part 312, Part 812.
• Knowledge of CTR (EU) No 536/2014 and EC Directives relevant to GCP.
• Organizational agility: strong analytical and problem-solving skills; able to work with limited supervision; travel up to 50%.

Aufgaben

• Audit Execution: Conduct external audits of clinical investigator sites, CROs, E-System providers, and IRBs/ECs.
• Reporting & Risk Categorization: Develop Audit Reports; categorize findings by risk and provide CAPA recommendations.
• Trend Analysis: Identify non-compliance trends and systemic risks; communicate findings to management.
• Continuous Improvement: Assist in SOP improvements for audits and partner with stakeholders on risk-based, compliant solutions.
• Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations and industry trends.

Kenntnisse

GCP QA experience

Audit management

Regulatory knowledge

Communication skills

ICH E6(R3) knowledge

Travel readiness

Ausbildung

BS degree in biological sciences

Jobbeschreibung

The Opportunity

This role serves as a GCP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of clinical trial data and compliance with legal and corporate standards. By conducting audits of our clinical investigator sites, external vendors, and internal trial management processes, you identify the findings and non-compliance trends that could impact the integrity of our clinical research. Seeking an experienced auditor who can navigate complex clinical environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability.

The Role

• Audit Execution: Conduct assigned external audits of clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs).
• Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.
• Trend Analysis: Identify non-compliance trends and systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
• Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for clinical trial management and monitoring.
• Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all clinical development programs.

Skills And Experience

• Academic Background: BS degree in a relevant biological science, science, or related discipline
• Professional Experience: 3+ years of Quality Assurance experience within a GCP-regulated environment, demonstrating a strong understanding of clinical trial phases, monitoring, and regulatory frameworks.
• Audit Expertise: Experience in clinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the clinical research discipline.
• Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational clinical teams, investigators, and external CROs.
• Working Knowledge of: ICH E6 (R3) Guideline
• 21 CFR Part 11 - Electronic Records; Electronic Signatures
• 21 CFR Part 50 - Protection of Human Subjects (Informed Consent)
• 21 CFR Part 312 - Investigational New Drug Application
• 21 CFR Part 812 - Investigational Device Exemptions
• Clinical Trials Regulation (CTR) (EU) No 536/2014
• Directive 2001/20/EC (Clinical Trial Directive)
• Directive 2005/28/EC (GCP Directive)
• Directive 2001/83/EC (Annex I)
• Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.