Are you interested in a Laboratory Quality role that allows you to make an immediate impact to a global business? If so, this position within Laboratory QA could be an ideal opportunity to explore.
The purpose of this role is to perform GLP and GCP quality assurance activities in GSK laboratories and / or external laboratories, to assure Pharma R&D senior management that GSK's GLP non-clinical studies, GCP clinical laboratory regulated activities and human biological sample activities are in compliance with local and global regulations and expectations.
This role is responsible for performing audits and assessments to implement the GSK Laboratory Quality Assurance GLP and GCP clinical laboratory monitoring programs, as well as to provide compliance support through advice and consultancy to the GSK R&D Laboratories, related supporting functions in GSK and our third-party partners.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Manage team activities related to QA outsourcing .
- Assure products meet regulatory requirements and that they conform to regulatory submissions.
- Participate in /manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues.
- Develop and incorporate effective processes and procedures in Global Quality Assurance ( GQA ) and may contribute to business processes and procedures outside GQA
- May interact with regulators.
- May be responsible for coaching, mentoring, training, or directing the activities o f one or more direct reports.
- Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
- Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
- Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK.
- Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to GQA and business units regionally and globally.
- Liaise with customers to provide compliance advice/input.
- Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.
- Establish improvement processes, as needed, or set specific measurable targets and goals linked to GQA /GSK business needs.
- Communicate and interact at various levels internally and externally to GSK.
- Build and maintain effective internal GSK business relationships within GQA and business units.
- Lead and assist in assessments of External Service Providers (national and foreign based) that are engaged in GLP work, supply of materials for GLP work , and the analysis of clinical samples
- May Lead and assist in internal assessments of GLP and GCP laboratories
- Conduct inspections of procedures and reports for GLP and GCP studies
- R epresent the group as a primary business contact for specific areas
We are looking for professionals with these required skills to achieve our goals:
- Sr. Advisor: B.S . or B.A. in a science related field with > 10 years of industry experience in GLP /GCP is required.
If you have the following characteristics, it would be a plus:
- Experience in performing activities relating to internal and external GLP/GCP Quality Assurance monitoring of laboratories .
- Excellent interpersonal and communication skills (both written and oral) and the ability to work productively in a team environment.
- Experience in providing GLP /GCP and quality advice and consultancy to b usiness areas .
- Good computer skills with experience in a number of applications .
- Must be able to demonstrate a high level of initiative and be very dependable.
- Excellent writing, organizational , able to work independently, and interpersonal skills are required.
Our values and expectationsare 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:
*This is a job description to aide in the job posting, but does not include all job evaluation details.
- 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.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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