Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


GlaxoSmithKline (GSK)

Senior Investigation Team Member- Hybrid (336525)

Pharmaceuticals

All

Yearly

No

Collegeville, Pennsylvania, United States

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: May 25 2022

This role ensures that Medicine Development and Supply is in a compliant state with respect to regulations and GSK policies/procedures. The holder will participate in the robust and timely investigation and recording of deviations across MDS. They will assist with the identification of trends and will deliver inspection-ready investigation reports.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

  • Leads complex or Critical deviations with the potential for direct impact on regulated systems or clinical supplies
  • Provides support to the MDS lines by leading or facilitating the RCA process associated with deviations and Independent Business Monitoring (IBM)
  • Supports Customer Complaints and Vendor Complaints as required by the business
  • Provides support to other team members with less experience of Root Cause Analysis (RCA)
  • Ensures the correct identification of root causes during investigations
  • Documents the outcome in a clear and accurate manner
  • Delivers robust outcomes to required timelines
  • Effectively communicates and collaborates with lines in the management and delivery of investigations
  • Contributes as Subject Matter Expert to the development of core business practices for the management of deviations, customer and vendor complaints
  • Leads or supports training in the quality processes
  • Contributes to trend analysis on past deviations to support recommendations for proactive interventions and improvements
  • Drives a culture of simplification by recommending, collaborating, and implementing effective and sustainable solutions across the MDS lines
  • Uses a thorough knowledge of compliance requirements (external and within GSK) to identify approaches and strategies which will ensure a compliant organization
  • Leads matrix teams/sub-teams and supports significant investigations, activities, or risk mitigation actions in areas of expertise
  • Contributes to the building of a compliance culture through the design and delivery of engagement communications, training, and activities

Why you?Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor’s degree in a scientific or related discipline
  • Experience in leading and resolving complex deviations
  • Experience delivering compliance outcomes through the application of expertise in deviation management
  • Knowledge of the relevant pharmaceutical industry regulations
  • Knowledge of the MDS business

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Proven ability to effectively assimilate and communicate compliance data to management for the purpose of driving corrective actions and mitigating risks
  • Able to negotiate and influence during investigations
  • Able to communicate and report clearly in an engaging and memorable way, tailored for targeted audiences
  • Demonstrated ability to work in a matrix in order to deliver robust investigations
  • Ability to collaborate both within department and beyond department as needed during investigations
  • Proven ability to drive for results within agreed timeframes

Why GSK?

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:

  • Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen.

*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-[Register to View] (US Toll Free) or +1 [Register to View] (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 [Register to View] site.