This job has expired

Senior Auditor, Laboratory QA

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Oct 14, 2022

View more

Discipline
Other, Manufacturing/QA/QC
Organization Type
All Industry, Pharma
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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.


Specific Accountabilities:

  • 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


Why you?

Basic Qualifications:

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.


Preferred Qualifications:

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. ​


Why GSK?

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:

  • 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.


*This is a job description to aide in the job posting, but does not include all job evaluation details.

*LI-GSK

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.

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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