Audit Manager, Clinical Quality Assurance, Open to flexible working
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
In this position you will be providing effective management of GCP Regulatory Agency Inspections and Issue Investigations along with leading studies and functional teams as a subject matter expert for the preparation, conduct and response to GCP Regulatory Inspections.
You will also be leading cross-functional teams to fully investigate serious compliance concerns, analyse results and agree appropriate and proportional actions to address.
In this role you will be responsible for monitoring compliance trends from inspections and investigations; and accountable for driving quality system improvements and ensure compliance.
Key Responsibilities include, but are not limited to:
- Support the development, management, and implementation of processes, associated written standards and job aides to support effective management of Regulatory Inspections and Issue Investigations across GSK R&D Development
- Coordinate and manage Regulatory Inspection activities for GCP process inspections both centrally and at Local Operating Companies. Serve as the main point of contact for inspection preparation partnering with risk managers to ensure business functions are prepared for both national and local inspections (FDA, EMA, MHRA, etc.). Ensure identification and mitigation of known quality issues and potential GCP compliance risks. Lead root cause analysis activities for any inspection findings identified and support the business in development of responses.
- Support the delivery of Regulatory Inspection activities for clinical programmes in partnership with the applicable CQA Programme Management Lead. Provide subject matter expertise to ensure effective inspection management.
- Provide proactive and regular communication of trends and performance metrics from all investigation and inspection activities across R&D to ensure effective implementation of controls, management monitoring and independent business monitoring.
- Establish strong working relationships with a network of contacts including clinical project team members, business function leaders, Risk Managers and Ethics & Compliance Officers.
- Maintain an up to date and in-depth knowledge of appropriate national and international GCP legislation and guidelines; and the impact to business area processes and procedures. Additionally, ensure intelligence is utilised for continuous improvement of inspection management processes.
- 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.
- Lead local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility.
Closing Date for Applications: Friday 2nd October 2020 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in related Health Science field or equivalent.
- A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance.
- Previous experience of Good Clinical Practice, Good Pharmacovigilance Practice and/or Quality Assurance.
- Extensive knowledge of global, regional and national regulatory requirements and regulations.
- Detailed knowledge of the drug development and clinical processes.
- Demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organisation.
- A demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies.
- Demonstrated experience interacting with regulatory agencies.
- The ability to function effectively and strategically as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively.
- Must have a high degree of organizational awareness and working towards resolution with complex problems.
- Have demonstrated project management skills and management of cross-functional activities.
- Have demonstrated ability for excellent verbal, written and presentation skills.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorisation before referring any candidates to GSK. The obtaining of prior written authorisation is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements.