This job has expired

Internal Audit Manager (GMP Audit Team)

Employer
GSK
Location
Collegeville, Pennsylvania; King of Prussia, Pennsylvania
Salary
Competitive
Closing date
Jun 29, 2022

View more

Discipline
Other, Other
Job Type
Manager
Organization Type
Pharma
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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…
  • 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.


Why you?

Basic Qualifications:

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


Preferred Qualifications:

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


Why GSK?

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.

*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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 authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization 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. For more information, please visit GSK's Transparency Reporting For the Record site.
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