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Director GMP Compliance Remediation & Support - Germany  

Company managed [?] Still accepting applications
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Posted on : 30 May 2017

Project Description

  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy. Our company’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
  • This position is critical in our Manufacturing Divisional effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products with an objective to enable consistently compliant product quality, continuous improvement and effective life cycle management.
  • Act as a cross-functional leader to Simplify, Standardize & Sustain our Compliance Remediation and Support department.  
  • This Director will ensure cross functional alignment and act as change agent for Director, Multi Products Compliance and Remediation Support.
  • Lead development and execution of significant innovation projects driving operational improvements related to all the topics supporting multi products– Compliance, Remediation and Support.
  • Support CAPA and inspection readiness processes that are critical to ensure a standardized and sustained QMS. 
  • Support alignment for those chapters related to quality/compliance and data integrity including alignments from Global QMS that may apply to inspection readiness, inspection support and remediation.
  • Ensure robust processes are in place and in use to maintain CAPA management and remediation support.  
  • This includes authoring documents, data entry of metrics and CAPA supporting compliance, remediation, and support.

Lead during efforts to support inspection remediation and CAPA management processes, demonstrated experience as a lead during Board of Health related inspections.
  • Develop the strategy and lead the implementation of the CAPA management and remediation across the Manufacturing Division network, GMP and AH activities including Research Labs; define the strategy for global requirements to drive harmonization of processes and systems
  • Lead the implementation of QMS requirements related to CAPA Management and Compliance Remediation Support.
  • Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS processes and alignments related to GMP and DI requirements.
  • Provide leadership and technical direction on regulatory GMP/GDP requirements
  • Initiate, where appropriate, and lead communities of practice to drive best practice sharing and continuous improvements across the Manufacturing Division network
  • Develop and proactively identify, investigate and resolve trends and patterns before they impact compliance and supply; define and drive implementation of performance metrics, as appropriate, to measure performance across the Manufacturing Division network
  • Influence and advocate our Manufacturing Division position on CRS processes  related to HA expectations through a strong network of external connections and effective external engagement
  • Anticipate external trends through benchmarking and regulatory intelligence activities and prepare the company proactively for changes and continuous improvements
  • Lead, Act, and Support activities to ensure robust processes are in place and in use to maintain our Manufacturing Division CRS and associated document
  • Lead development and execution of significant innovation projects driving operational improvements; this will require cross-functional support within the Global CRS team and Global QA and External Affairs.

Education Minimum Requirement:
Bachelor's degree in Life Sciences, Engineering or related relevant discipline.  Advanced degree preferred.

Required Experience and Skills:
  • Thorough understanding of regulatory requirements for drugs, devices, biologics, including quality risk management and knowledge management
  • Minimum of 15 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality; experience in vaccines, biologics, devices and API regulations preferred
  •  Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS in a drug, device and biologics manufacturing environment
  •  Strong project management skills
  •  Capable of working and communicating effectively with all levels of the organization globally
  •  Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management
  •  Proven ability to influence effectively without hierarchical authority multi-functional professionals to drive harmonization and proactive compliance
  •  Proven ability to effectively initiate and drive change across the Manufacturing Division network
  •  Self-motivated with a high degree of ownership and accountability for results

Travel: Yes, 50 % of the Time

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