Cqa Audit Manager

**_Be You’ at GSK_**

At GSK, we're a company with a purpose to **help people do more, feel better and live longer. **We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to **our values. These **are at the heart of everything we do and include**:Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.**

**When you set out on your adventure at GSK, we make a deal. **You commit to living our values and expectations and performing against our **Innovation, Performance and Trust **priorities. In return, GSK commits to providing the **right environment for you to thrive. **Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a modern employer, we empower you to be yourself, share ideas and work collaboratively

**_
CQA Audit Manager_**
**About the role**
**In this role you will**:

- Provide Independent Quality Assurance to GSK R&D, by delivering the audit program including defining scope, conducting audit processes, reporting observations and ensuring receipt and review of CAPA plans.
- Identify compliance issues, monitor trends, be accountable for driving quality improvements back into R&D Business Functions and improve processes.
- Support QA activities during regulatory inspections and build solid working relationships with Risk Managers and Ethics & Compliance Officers, establish a network of contacts, and maintain knowledge of local regulatory frameworks and global regulatory reporting requirements.
- Build a network of contacts including business function leaders, Risk Managers and Ethics & Compliance Officers.
- Partner with these contacts to ensure business function is prepared for regulatory inspections; support and where applicable host local and global inspections.
- Proactive and regular communication of trends and performance metrics from QA, audit and inspection activities within the business function and across R&D to ensure effective implementation of process controls, management monitoring and independent business monitoring.
- Maintain knowledge of local regulatory frameworks, and clinical research activity.

**Key responsibilities**:

- Independently plan, lead, and conduct routine and complex CQA audits of GSK studies, systems, external vendors and GSK Operating Companies to assure compliance with GCPs and GSK policies and procedures, and applicable local regulations
- Effectively document audit findings in an audit report and obtain responses in a timely fashion
- Report and present to clinical development staff, clinical investigators and contract research organization staff findings from audits and give advice on resolving issues identified
- Generate and provide metrics, status and trend reports and other information, as required by management
- Partner with CQA Management to develop, implement and assess clinical quality assurance strategies, organizational and operational needs
- Act as a consultant and represent department to clinical development staff and teams in relation to compliance, quality improvement, business redesign initiatives and risk assessment
- Provide expert advice in relation to obtaining compliance, quality improvement, process and program initiatives and risk assessment and act as point of contact for customers and CQA staff
- Maintain an up to date and in-depth knowledge of appropriate national and international GCP legislation and guidelines; and the impact to assigned business area processes and procedures
- Educate, guide and influence GSK management and staff on best quality and compliance policy and practices, especially as they relate to areas of identified responsibility
- Assist in developing and maintaining customer training programmes and help deliver training within area of expertise
- Work independently and as a member of assigned CQA team
- Build and maintain beneficial working relationships with all internal and external customers
- Lead local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility
- Deputise for manager and take on delegated duties as required
- Support the recruitment of new CQA staff
- Manage/Champion and participate in other projects or duties assigned by the CQA management specific to CQA teams accountabilities.

**_
This job opportunity is a permanent contract _**_not_**_ opened for relocation._**

**_
- **

**_Please note that depending on your profile and experience we may offer to employ you in the grade different from the position_**_ _**_grade._**

**_
Why you?
- **

**Qualifications & Skills**:

- Bachelor’s degree in related Health Science field or equivalent. An advanced degree would reduce the work related experience requirement.
- A broad