Post-Approval Change Planning Lead (Regulatory Affairs)

Collegeville, Pennsylvania
February 11 2021
Organization Type
Are you interested in a global post-approval change planning role, working across GSK's global biopharmaceutical portfolio to ensure the most effective regulatory strategy across our biopharmaceutical supply chains.? If so, this Post-Approval Change Planning Lead role could be an ideal opportunity to explore.

The post-approval regulatory landscape for biopharma products is complex and resource intensive, and there is a need for integrated planning across product portfolios to ensure the most effective regulatory strategy across our biopharmaceutical supply chains. The key purpose of this role is to work with colleagues in the biopharma mature products CMC RA team, Pharma Supply Chain Change Planning Leads, and the manufacturing sites to establish effective post-approval change management plans for the commercial biopharma product portfolio.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • Liaises with Pharma Supply Chain change planners to establish integrated plan for change management across the biopharma product portfolio
  • Works alongside biopharma mature products CMC RA team leads to ensure that effective post-approval plans are created, maintained and implemented across the portfolio
  • Participates in cross-functional matrix project teams, which include colleagues from regulatory, quality and manufacturing (compliance and technical), to aid the planning of manufacturing changes
  • Assessment of impact across the portfolio of major supply chain change initiatives
  • Accountable for planning of changes to facilities registered detail for biological products, where required
  • Supports ongoing efficiency and cost saving through implementing process improvements for change management, aligned with Commercial and PSC strategies

Why you?

Basic Qualifications :

We are looking for professionals with these required skills to achieve our goals:
  • BSc with focus in Life Sciences, Product Development or Quality Assurance

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • PhD with Life Sciences focus
  • Strong understanding and interpretation of regulations, guidelines and timings for post-approval change for biopharmaceutical products.
  • Ability to influence the prioritization of proposed manufacturing changes.
  • Experience of managing complex post-approval change for pharmaceuticals or vaccines.
  • Detailed knowledge of drug development and/or manufacturing and supply processes
  • Detailed working knowledge of worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
  • Successful track record of managing multiple projects/teams simultaneously and working knowledge of project management tools.
  • Excellent team working abilities and effective influencing skills
  • Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
  • Demonstrated ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives

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:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor 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.

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.

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