Manager, GVP Quality Assurance

Location: London (Remote)

Reporting to: Director GCP, GLP & PV Quality Assurance at Orchard Therapeutics

Job Summary

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases.

This role will report to the Director GCP, GLP & PV Quality Assurance and will be responsible implementing the associated strategy that ensures Orchard fosters and promotes a GVP-compliant environment with internal and external stakeholders and for providing day-to-day PV Quality Assurance support to the Orchard Pharmacovigilance (PV) teams and staff involved in activities impacting on Pharmacovigilance

We are seeking a candidate with strong PV knowledge, audit skills, communication, and facilitation skills, including the ability to manage multiple projects.

Key Elements and Responsibilities

· PV QA Compliance Lead supporting operational PV activities.

· Leads the development of company risk-based PV audit strategies and manages audit plan execution.

· Handles multiple projects and ensures overall and timely completion of tasks.

· Manages and/or leads GVP routine and complex audits including but not limited to internal processes, vendors and business partners.

· Manages contracts GVP auditors.

· Works closely with the PV function to provide expert PV compliance information, manage identified issues, and support continuous improvement.

· Manages PV inspection readiness preparations and/or directly support regulatory agency inspections. Assists in the coordination of response to findings coming from inspection.

· Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).

· Evaluates, writes and/or reviews operating procedures (e.g. SOPs), and performs other activities in support of an integrated cross-functional quality management system (QMS).

· Provides consultative support for the management of compliance for PV training delivered to Orchard personnel.

· Provides consultative support to draft/review of PV Agreements/Safety Data Exchange Agreements (SDEA)s.

· Manages the “Annual Tactical Level Pharmacovigilance Audit Schedule for Orchard”.

· Provides consultative support to review Marketing Authorization (MA) transfer protocols

Requirements

Required Knowledge

· QA Professional with a minimum of 5 years of PV experience

· Substantial previous work experience.

· Must have significant GVP audit and compliance experience. Bio-pharmaceutical sponsor experience preferred.

· Demonstrates knowledge and experience in conducting and reporting of audits and the translation of findings into corrective action plans that mitigate risks to the Company, to safety and Data Integrity.

· Experience with audit management/CAPA management programs.

· Recognized as an expert resource on a range of GVP compliance topics.

Skills & Abilities

· Strong verbal and written communication skills and interpersonal skills.

· Proficient in Microsoft Office suite.

· Excellent organization skills and project management.

· Excellent problem-solving skills.

· Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused entrepreneurial environment.

· Experience and ability to conduct GVP audits both within and outside EU

Education

· BA or BS and 6+ years of relevant experience

· Certification as a GVP auditor is a plus.