Project Oversight Senior Scientist, Quality Control - Upper Providence (Latrobe)

Employment Type

: Full-Time

Industry

: Miscellaneous



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This role provides Quality Control oversight of Cell and Gene Therapy (CGT) projects in development.

Key Responsibilities:

  • Represent Quality Control within MPD Analytical Workstreams
  • Ensure change controls, quality deviations and out of specification results under area of responsibility are rapidly escalated to QC management and QA.
  • Ensure quality, safety and business risks for area of responsibility are managed through the CGT risk management process or escalated to the Analytical Workstream Lead as appropriate. Inform management of risks observed outside of area of responsibility.
  • Apply GSK QMS to all work in area of responsibility and escalate any gaps to management, MPD team, risk council as appropriate.
  • Author or review and integrity check data and/or commentary generated for regulatory submissions in area of responsibility.
  • Ensure that GSKs technical, quality and delivery requirements for specific work packages under area of responsibility and performed at third parties are met or any gaps are escalated.
  • Contribute to analytical delivery plans. Highlight any resource or delivery concerns.
  • Ensure that assigned training is kept up to date and any gaps in assigned training are escalated.
  • Contribute to the implementation and continuous improvement of CGT QC systems and processes as required.
  • Represent CGT Quality Control during internal or regulatory inspections as required.
  • Why you?

    Basic Qualifications:

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

  • Bachelors degree with 3 years of pharmaceutical industry experience
  • Experience of Quality Control and/or Analytical Development
  • Experience of product development / delivery
  • Writing scientific, regulatory and quality documentation
  • Risk management
  • Knowledge of the requirements and importance of managing quality deviations, change controls and OOS results
  • Qualification and Validation of Analytical methods
  • Tech Transfer of Analytical Methods
  • Preferred Qualifications:

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

  • Matrix leadership
  • Why GSK?

    At GSK our values and expectations result in 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, rigor and risk
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Ethical behavior
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US).

    GSK is an Equal Opportunity/Affirmative Action Employer. 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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