At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realizing our purpose starts with us. When we feel at our best, we perform at our best.
When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.
Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.
As Manager, GMP Audit Team, this is an opportunity to join a global Quality Assurance team responsible performing internal audits of GMP functions and activities performed at all US and UK Pharma R&D sites. This role allows an individual to be empowered to drive global harmonization and efficiencies, define and implement program improvements, and provide expert advice on regulatory requirements. The role also provides exposure to a variety of R&D activities including clinical manufacturing, packaging and labeling of clinical supplies, analytical testing, Third Party Management, validation, calibration and maintenance, Cell & Gene Therapy, etc.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Why you? Basic Qualifications:
- Lead internal audits according to the defined Pharma R&D audit universe and schedule, including assessment planning, report authoring and close-out.
- Support the ongoing update of the audit universe in line with emerging issues or changes to regulatory expectations.
- Author audit reports including risk based findings.
- Make recommendations for corrective and preventative actions using established Root Cause Analysis.
- Review and approve internal audit assessment reports.
- Identify and mitigate compliance risks to GSK through effective audits.
- Establish improvement processes, as needed, or set specific measurable targets and goals linked to the audit program.
- Build and maintain effective internal GSK business relationships within PQPRD and business units.
- Communicate and interact at various levels internally and externally to GSK.
- Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.
- Provide support to multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
- Provide general QA oversight and consultancy with regards to regulatory expectations to reduce regulatory risk to GSK.
- Represent the group as a primary business contact for specific areas.
- Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
- Liaise with customers to provide compliance advice/input, including providing input in support of Quality Councils across the R&D business.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree
- 5+ years of experience in the Pharmaceutical industry
- Experience leading and managing internal audits/assessments
- Knowledge of GxP areas and regulations
If you have the following characteristics, it would be a plus:
- Broad knowledge of the R&D drug development process/pharmaceutical industry
- Experience defining or managing an audit program
- Experience with root cause analysis
- Strong interpersonal skills
- Strong verbal and written communication skills
- Able to interact with peers, subordinates, and senior personnel in a multidisciplinary environment.
- Able to prioritize and decide appropriate course of action
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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