Specialist QA Gcp Auditor

5 months ago

High Wycombe, United Kingdom Johnson & Johnson Full time

**"Caring for the worldone person at a time” **inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable **Credo**

**Specialist QA GCP Auditor (M/F/d)**

**Location: Europe or America**

**Job summary**

Johnson & Johnson Innovative Medicine are recruiting for a Specialist QA GCP Auditor located in Europe or America.

In R&D Quality, we continue to invest in our talent, diversity, and expertise, to make quality a business differentiator and competitive advantage - allowing our business partners to better deliver what really matters to customers and patients. QA delivers innovative risk-based audit and quality control approaches that provide relevant insights to proactively secure compliance and drive sustainability and reliability across Johnson & Johnson Innovative Medicine.

**Key responsibilities**

Auditing:

- Leads the planning, conduct and reporting of GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits, to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
- Ensures the relevant standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.
- Analyzes, interprets data and identifies patterns and trends in data sets.
- Ensures timely and appropriate review & delivery of CAPAs and actions arising from audits.
- Presents information logically and concisely, both verbally and in writing, including writing reports with clarity
- Provides GCP Audit strategy support, especially on QA risk-based auditing approach (Audit plans)

Inspection Support:

- Supports regulatory inspections in various supporting roles.

Training & Development:

- Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
- May assist in the preparation of training material if requested.

Project Management:

- Participates in projects or serves on teams, as assigned by supervisor.
- Meets priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.

**Qualifications**:
**Qualifications**

**Education**:
**Experience and Skills**

Required:

- Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology.
- Knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. FDA regulations, EU CTR, ICH E6 R2
- Understanding of fundamentals of clinical trial risk management.
- Broad knowledge of management of standard operating procedures, good documentation practices, and records management.
- Ability to plan and prioritize work in an efficient manner, and to work well under time constraints.
- Flexibility to respond to changing business needs.

Preferred:

- Familiarity with new and emerging technologies and analytics, and the ability to see opportunities where creative capabilities may be applied within QA audit processes
- Experience conducting Clinical Quality Assurance audits.
- Ability to interpret global regulatory standards.
- Inspection support experience (FDA, EMA and other inspectorates).
- Conflict resolution/management skills.
- Strong networking and relationship building skills.
- Experience balancing multiple projects simultaneously.

**Other**
- Must be proficient in English
- Travel Up to 30% required (national and international).

**What we offer**

Our employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company. We do everything we can to enable you to develop your full potential with us.

We are very proud of our open, appreciative corporate culture and value a healthy balance between work, family and leisure. Flexible working time models such as part-time, flexible time and home office can be adapted to your life. Our proactive health program and our company fitness center take care of your mental and physical well-being.

**Working at Johnson & Johnson**

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Cred

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