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Veterans Preferred – Change Control Global Process Owner

Gsk

This is a Contract position in North Carolina, PA posted September 2, 2021.

Military Veterans are Encouraged to Apply.  
Are you energized by a highly impactful strategic role that drives quality improvement and senior stakeholder engagement?  If so, this Change Control Global Process Owner role could be an ideal opportunity to explore.
As a Change Control GPO, you will be a member of leadership team and be responsible for providing strategic direction and leadership to the business.  You will diagnose where change is needed and implement cross functional organisational change projects which significantly improve business performance.

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

  • Drive standardization, innovation, and compliant E2E Change Control process across the network
  • Lead/facilitate community of practice (CoP) across the network including R&D
  • Support audit findings and preparation on topic, act as an audit coach as needed
  • Drive the implementation needs: training of sites, support of gap/implementation assessment, tackling barriers to successful implementation at sites/LOCs
  • Liaise with site SMEs throughout the process: impact assessment, design, review, implementation
  • Knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertise
  • Define deployment strategy within PSC (QMS direct to LSOP or PGSOP/TS) and R&D and have it endorsed at QMS Tier 1 meetings (PSC and R&D)
  • Design and author the PGSOP and R&D Global SOP when required, in collaboration with One Pharma QMS exec and R&D SMEs.
  • Drive simplification of the process, streamline ways of working and simplify competency-based training for all change control related roles (Change Owner, Change approver), providing training packs and capability across the network and R&D.

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

  • Bachelor’s or Master’s Degree Biological sciences, chemistry, pharmacy or related scientific or technical discipline
  • 10 years of direct experience in Quality or Compliance role and/or equivalency in education and experience with 8-10 years of managerial experience.
  • At least 5 years experience of interacting with FDA or other regulatory agencies like MHRA.
  • Have extensive Expertise/Knowledge of global process.

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

  • PhD Biological sciences, chemistry, pharmacy or related scientific or technical discipline
  • Excellent SME level understanding of ICH Q10 Pharmaceutical Quality System
  • Good understanding of how the topic/QMS process is implemented within LOCs, PSC and R&D
  • Knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertise
  • English writing skills
  • Communication skills (other BU reps, sites)
  • Change agent

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, governance and control, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.
  • Setting strategic direction and leading on-going organisational transformation.
  • Building a resilient organisation.
  • Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
  • Managing P&L and capital allocation.

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

*LI-GSK

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