Product Quality Strategy Leader Senior Director - Dresden, Deutschland - GSK

GSK
GSK
Geprüftes Unternehmen
Dresden, Deutschland

vor 1 Monat

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

Site Name:
Belgium-Wavre, Dresden, Godollo, Italy - Rosia, Marburg Main Site, Saint-Amand-les-Eaux, USA - Pennsylvania - Upper Providence


Posted Date:
Feb


Product Quality Strategy Leader Senior Director:


Job purpose:


The Product Quality Strategy Leader (PQSL) Senior Director is accountable for end-to-end Product Quality Strategy for products from pivotal or phase III including process/method validation, approval, launch, and post approval lifecycle management.


This role is accountable for product quality, compliance and continuous improvement during the product lifecycle as required based on risk, regulatory requirements, continuous process/method verification, commercial strategy and/or supply needs.

Other responsibilities include ensuring robust supply chains are in place to enable product launch activities executed by the operations teams (sites and global functions) and ensure internal and cross-functional alignment with industry and regulatory expectations.


This role is the primary quality interface between functional partners (MSAT/R&D/Manufacturing Unit/Regulatory) and must ensure strong collaboration to deliver business goals and resolve complex issues related to product quality.


Key Responsibilities:


  • Lead a team of Product Quality Strategy Leaders responsible for developing endtoend product quality strategic plans with clear ownership for each deliverable and alignment with R&D, Manufacturing Science & Technology (MSAT), QC Analytical Leads, Regulatory Lead and Development/Manufacturing Strategy Leaders
  • Develop robust product quality strategy plan with clearly defined quality expectations for in licensed and outsourced products, ensuring compliance to global regulatory expectations and internal GSK QMS standards
  • Accountable for the product Quality overview of the product control strategy (CPP/CQA) and for the final approval of the product control strategy including the associated specifications, stability strategy and product shelf life
  • Partner with other quality functions to champion the critical quality management systems that will enable right firsttime launch and product robustness, e.g. change control, process validation, method validation and quality risk management
  • Role is accountable for product and analytical quality approval of file to Health Authorities and submission approval to Health Authorities for final registration documentation (CMC commercial for first filing) and major variations during lifecycle
  • Represent and interface with manufacturing and testing sites to champion a consistent approach to Quality and compliance standards across sites
  • Identify and assess quality risks (through continued process verification, continued method verification activities and annual product review) and proactively work with stakeholders to carry out mitigation and improvement plans to deliver robust supply chains
  • Ensure team of product quality strategy leads have plans in place to continuously develop the required competencies, drive standardisation, manage workload
  • Develop strategy for attracting and retaining key talent to ensure strong succession plans for product quality strategy lead roles
  • Serves as the global resource in the organization to provide product quality expertise, including audit and inspection preparation support (i.e. Product Quality related A&A audits)
  • Proactively represent and promote GSK's product quality interests externally

Requirements:


  • Bachelor's degree or equivalent experience in Chemistry, pharmacy, biological sciences, science related
  • 10+ years' experience in Quality function in a highly regulated environment
  • Demonstrated leadership skills across functions and organisational levels
  • Deep knowledge of CMC and quality requirements, and Regulatory Authority Inspections
  • Experience in strategy development and deployment
  • Sound and timely decisionmaking and problemsolving skills in high impact situations
  • Proven track record of leading teams successfully in a cross functional/ global setting


If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.


Why Us?


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 organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 every
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