Key Responsibilities
To perform the role of Audit & Vendor Manager on behalf of Autolus, with primary responsibility for managing and executing a broad range of Good Clinical Practice (GCP)-focused audits, including internal audits, investigator site audits, and external vendor audits. This role plays a critical part in ensuring ongoing compliance and quality within our clinical development programs.
As a key member of the Clinical Quality Assurance (CQA) team, you will lead planning, execution, and reporting of GCP audits across Autolus clinical trials, processes, and vendors. You will also oversee the qualification and ongoing management of clinical vendors, collaborating closely with contract owners throughout the vendor lifecycle. Additionally, you will support regulatory inspection readiness and inspection activities at both Autolus and investigational sites.
Note: This role requires international travel of up to 30%.
Key Responsibilities
* Lead the planning, conduct, and reporting of international GCP audits, including internal, investigator site, and vendor audits.
· Manage audits conducted by third-party audit vendors, ensuring consistent quality and alignment with Autolus standards.
· Maintain and update the annual risk-based audit plan, with formal reviews conducted biannually.
· Track and report audit metrics, including risk indicators and trends from audit findings.
· Oversee the qualification, onboarding, oversight, and offboarding of clinical vendors in collaboration with contract owners.
· Ensure that SOPs supporting audit and vendor management processes are optimised, current, and aligned with best practices.
· Proactively identify and escalate compliance risks to CQA and R&D management.
· Contribute to, or lead, process improvement initiatives within CQA.
· Keep the Director of CQA regularly informed on audit progress and highlight any critical issues.
· Support inspection readiness activities and regulatory inspections (e.g. mock inspections, preparation of documentation, front/back room support).
· Ensure compliance with Autolus quality standards, policies, and procedures.
· Perform other duties as reasonably assigned by your line manager.
Demonstrated skills and competencies
E- Essential
P- Preferred
Qualifications & Experience
* Degree (graduate or postgraduate) in a scientific discipline (e.g. life sciences, pharmacy, nursing), or equivalent relevant experience in clinical research or clinical QA. E
* Significant experience conducting international GCP audits or serving as an inspector within a regulatory authority. E
* Strong background in vendor qualification, oversight, and relationship management. P
* A recognised Clinical Research or Clinical Audit qualification is desirable. P
* Experience with GCLP and/or GVP audits is advantageous but not essential. P
* Proficiency in data mining and analytics would be beneficial. E
Skills, Knowledge & Competencies
* Excellent verbal and written communication skills. E
* Strong influencing, negotiation, and conflict resolution abilities. E
* Deep understanding of GCP and applicable international regulatory guidelines (e.g. ICH, FDA, EMA, HTA). E
* Working knowledge of other GxPs (e.g. GMP, GVP) is a plus. E
* Analytical thinker with a strong risk-based mindset. E
* Ability to engage and communicate effectively across all levels of the organisation. E
* Collaborative and flexible approach to working with internal teams and external partners (CROs, vendors, consultants). E
* Self-motivated and highly organised, able to prioritise effectively and work under pressure. E
* Decisive, with the ability to manage ambiguity and resolve issues pragmatically in a fast-paced biotech environment. E