Quality Assurance Manager
Vor 2 Tagen
**Reports to (Title): Global Head of Quality Assurance & Training**
**Location: Europe or US**
**Exempt/Non-Exempt: Exempt**
**Direct Reports : No**
**Department: Quality Assurance & Training**
The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative medicines portfolio for the US, Europe and Japan. Our ex-China team drives strategy and operational implementation for clinical development, regulatory approval and commercial success.
Our parent company Jiangsu Hengrui Medicine (600276 SHA) is a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. Our pipeline opportunities include antineoplastic, metabolic, cardiac, surgical, contrast agents, anti-virals, and antibiotics. The therapeutic areas are diverse, covering oncology, autoimmune, pain management, neuroscience, metabolics, etc.
We recognize, appreciate, and reward our team's contributions; we emphasize our people's well-being. We want our employees to feel empowered to do their best work, to engage in shaping our growing ex-China organization and to be part of a team where they are respected, engaged, fulfilled, and developing
**Job Summary**:
The Quality Assurance Manager is involved in the quality, compliance, and auding activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations.
Responsibilities include supporting the development of an integrated Quality Management framework including the development of procedural documents, implementation and maintenance of quality management systems, developing a risk-based audit strategy, providing compliance support to clinical development teams, and supporting Health Authority inspection preparation activities.
**Essential Job Functions**:
- Partner with the Information Technology department to implement systems to support quality management activities (e.g., eDMS, LMS, eArchiving).
- Support the creation of a risk-based audit strategy including performing risk-assessments, identifying audit targets, contracting with external consultants to conduct audits, review of audit reports, and any CAPAs needed.
- Escalate and manage the mitigation of critical audit findings, issues, and serious breaches as required per Standard Operating Procedures.
- Assist Head QA Department with the development and monitoring of KQIs and KPIs.
- Collaboratively work with other functional departments to build Third-Party Management processes (e.g., a Vendor Identification and Qualification process, Vendor Oversight,
Re-Qualification).
- Support the development of QA Standard Operating Procedures and provide QA support to other functional areas to develop and maintain procedural documents across the organization, ensuring compliance with GCP/GVP regulations.
- Attend cross-functional study team meetings and provide guidance to staff based on interpretation of current regulations to ensure best practices.
- Support Development Operations to design and implement a Risk-Based Quality Management framework for clinical studies, Risk Assessment Tools, and Risk-Based Monitoring processes.
- Support study teams in performing root cause analysis of compliance issues and creating effective CAPA plans as needed.
- Facilitate review of emerging regulations and guidelines across the organization to ensure regulatory compliance.
- Support Head QA Department with the preparation, coordination, and management of regulatory agency inspections.
- Collaboratively work with other members of the QA and Training department as needed to support the development of role-based training curricula and the distribution and monitoring of training compliance across the organization.
- Other tasks as assigned.
**Job Requirements**:
**Experience / Education**
- Bachelor's degree and 5+ years of GCP/GVP Quality Assurance or Regulatory Compliance/Auditing experience required.
- Strong knowledge of Regulatory guidelines (ICH, FDA, EMA).
- Experience with GCP/GVP auditing and vendor audits.
- Knowledge or experience with GLP or GMP requirements a plus.
- Risk Management and/or process improvement methodologies certification
(e.g., Lean Six Sigma) a plus.
**Knowledge/Skills/Abilities**:
- Experience with GCP/GVP Audits (Internal, Investigator Site, and Vendor Audits).
- Experience working in a Quality Management Framework including elements such as
Risk Management, Third-Party Management, and CAPA management.
- Thorough understanding of clinical research, drug development, and operational activities and processes.
- Excellent active listening, communication, and collaboration skills to work effectively on cross-functional global teams.
- Ability to problem solve and make informed decisions while maintaining high ethical standards.
- Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
- Strong attention to detail and resp
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