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Senior Director, International Quality Operations – Paddington, London – Permanent

Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Senior Director, International Quality Operations.

Based in Paddington, the Sr. Director, International Operational QA will advance and provide strategic direction and oversight of the International global expansion worldwide across all product portfolio. This role will establish processes and capabilities for effective and proactive quality risk management across respective product / therapeutic program area(s) (e.g.; Cystic Fibrosis). The successful candidate will have overall responsibility for establishing appropriate global and local QMS, hiring of appropriate Qualified Responsible Persons / QA in local countries / affiliates and assure real-time inspection readiness. This individual will provide strategic oversight and leadership for Quality Management Reviews, ensuring transparency for gaining insights regarding effectiveness of risk mitigation strategies / controls, proactive and sustainable compliance. In addition, they will integrate end-to-end quality principles and review preparedness at key milestones in alignment with organizational and project milestones.

The Sr. Director, International Operational Quality leader will foster strong collaboration and partnership with external and internal stakeholders; the international leadership team, business stakeholders, strategic alliances / collaborators and regulatory agencies globally. This candidate will ensure alignment with Quality leadership and teams (e.g. audit, vendor management) in development of integrated strategies for the international expansions and sustained compliance across all affiliates, process and vendor oversight and assurance. They will provide strategic guidance and direction to the integrated benchmarking and external environmental monitoring for identifying emerging industry trends and best practices (e.g. operating models, capabilities) to facilitate maximum value to evaluation of the health of the quality system and identification of cross functional risks that will require assessment by the functional areas.

The Sr. Director of International Operational Quality will be one who has demonstrated success in understanding and establishing of affiliate business units and build out of international quality organization that supports the business strategy that assures compliant outcomes and operational excellence.

Specific responsibilities will include:

Serves as the International Operational Quality leader with accountability for strategic leadership and oversight of the end-to-end quality strategy for proactive and sustainable International quality and compliance across internal affiliates and business offices that support the release and distribution of marketed products across the portfolio:

  • Provides strategic direction and oversight to development, execution and continual improvement of quality risk management / mitigation strategies that meets the global international requirements.
  • Design effective QMS that meets the regulatory requirements in collaboration with the business stakeholders across Global Medical Affairs, Regulatory, Supply Chain, Patient Safety etc. for alignment of quality strategies, goals and approaches in support of quality outcomes and real time inspection readiness.
  • Leads and / or provides strategic direction / oversight to staff leading quality working groups to define integrated quality plans / activities to deliver the overall quality strategy across QA functions (e.g. audit, operations, vendor management, etc.).
  • Engages and provides consultation to business partners in advancing proactive and leading quality approaches incorporating best practices and establishing / developing strategies for new models, technologies, and practices.
  • Serves as Quality representative to cross-functional teams, International Leadership and quality governance bodies as applicable.
  • Manages for cause, critical and / or complex quality issues for the program area.
  • Strategic leadership of proactive regulatory intelligence and inspection readiness strategies and review at key project milestones in support of organizational deliverables and decision making models.
  • Provides strategic direction in the oversight and continual advancement of the global and local QMS framework / model for optimizing operational performance across QA and the business areas as well as in collaboration with the Integrated QMS function in QA.
  • Leads / chairs integrated International QA Operational Management Reviews / local affiliates.
  • Management reviews for ensuring cross-QA transparency and gaining insights regarding efficiency and operational performance across QA, including identification of opportunities for improvement.
  • Partners with QA leadership and managers for determination of needs for tools, metrics, mechanisms and systems enabling individual manager accountability and ownership for decision making in ensuring operational performance (budget, resource, goals / objectives) across their scope of responsibility.
  • Provides expertise and strategic oversight and direction to development and advancement of progressive models and mechanisms for risk management identification, mitigation and communications across QA supporting enhanced planning, prioritization, resourcing strategies and projection of future needs and capabilities.
  • Provides leadership coordination and direction to benchmarking with external peers and industry for establishing QA operational performance targets / goals in support of excellence, value and impact.
  • Provides leadership and partners with QA management in proactive and strategic planning for QA and translation of the strategy to operating plans for execution.
  • Partners with stakeholders across enabling functions for alignment of strategies, and optimization of programs for delivery, specifically with respect to corporate vs. QA-specific initiatives.
  • Partner with the International regulatory function in regulatory strategies and communications with regulatory agencies.
  • Support R&D programs, inspections and clinical regional release globally as needed.
  • Experience in Gene and Cell therapy manufacturing and distribution will be critical to setting future strategies to support the organization’s growth and expansion.

Required Skills, Knowledge & Competencies:

  • Broad and deep global health regulatory agency knowledge and experience across multiple GDP /GMP / PV with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness.
  • General knowledge in electronic system compliance and GCP / GLP requirements.
  • Knowledge and demonstrated experience in application of risk-based quality principles (e.g. QbD) in a pharmaceutical environment.
  • Broad and deep operational and project management knowledge and experience.
  • Demonstrated strategic planning and execution skills required.
  • Proven ability to design / evolve and / or implement quality strategies and operational planning and oversight in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model.
  • Current knowledge of industry trends and best practices – for progressive quality risk management in a regulated environment.
  • Developing individuals and teams; proven leadership capabilities within multi-level Organization.
  • Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness.
  • Excellent communication skills and a proven track record Influencing / building / promoting a culture of Quality and Excellence.

To be considered for this position please apply below.