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Liverpool

    China Registration Compliance Lead - Liverpool, United Kingdom - Danone

    Danone
    Danone Liverpool, United Kingdom

    1 week ago

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    Description

    Short Intro and About the Job

    We have an exciting new role based in Wavertree, Liverpool who will lead a site-based China registration Compliance team in the development and delivery of a robust technical strategy that ensures Nutricia Liverpool delivers products of consistent quality to specified standards, uncompromising food safety and hygiene, in line with Danone Food Safety standards and country specific registration / regulatory requirements.

    As China Registration Compliance Lead, you are responsible for the identifying the gap to compliance, management and execution of China project activities and associated accreditation requirements. Ensuring full deployment of all requirements of Annex 4, GMP and associated GB standards across all areas of the business to ensure requirements are sustainably embedded and regularly reviewed for adherence. To identify capex-based requirements to ensure compliance to regulatory requirements.

    You will work proactively alongside key stakeholders to effectively manage communication and reporting requirements and build relationships both internally and externally to enable stakeholder challenge and support to maximize technical excellence. Responsible for fostering a culture of continuous improvement, you will work with alongside colleagues to ensure delivery of core activities in line with, ISO, FSI and FDA standards, SQCDME, the site's strategic vision.

    You will be responsible for ensuring all operations within the areas of responsibility are carried out in a safe manner. To be fully aware of company procedures relating to Fire Evacuation, Accident Reporting, and Food Safety. To ensure all staff behave in a safe and responsible manner within the area of responsibility.

    You will also be responsible for managing and leading China project team to achieve the key deliverables and reduce gap to regulatory standards. Accountable for the growth and development of the team through robust development plans, and conversations and inspiring excellence.

    Core Activities of the role:

  • Lead the registration process ensuring timely submissions for on time market access.
  • Remain at the front of changing regulatory requirements and adjusting registration strategies.
  • Lead the China market audits . and work alongside the Head of Quality to ensure compliance to all regulatory frames . FDA (Food and Drug Administration).
  • Lead factory related preparation of registration dossier including recipe registration and factory registration.
  • Stakeholder management with internal / external stakeholders
  • Understand the dynamic environment - emerging best practices in registration and quality compliance.
  • Perform gap assessment against the new regulations and define clear Roadmap to ensure gap closure and regulatory compliance.
  • Write validation reports to support product dossier submission such as homogeneity validation and process capability.
  • Prepare Liverpool site for an external SAMR audit, based on the findings from the China CBU mock audit and other audits.
  • Communicate China / FSI standards to ensure any site impact, especially related to food safety and quality standards are met.
  • Coordinate complex projects related to product registrations, ensuring timely execution and quality compliance.
  • Work alongside key stakeholders to ensure adherence and enforcement to the sites Quality Management System, which reflects the site's commitment to Food Safety Legality and Quality and satisfies third party requirements. Ensure that the system satisfies the requirements of the UKAS / FDA / FSMP and country specific requirements for product registration.

    • KPI Reporting & Escalation

  • Establish appropriate KPI's reflective of the Registration Compliance activities undertaken that establish the effectiveness of the department.
  • Responsible for ensuring that any issues relating to Registration Compliance deviation relating to safety or legality of product are identified and communicated to the Head of Quality and the Supply Point Director for review at a strategic level.
  • Responsible for providing reports as required by the Site Management team, external stakeholders or other designated Managers. Produce regular quality performance reports to assist key stakeholders in eliminating non-conformances. Develop and maintain an organised record keeping system within the site.

    • Budget Controls

  • Responsible for producing an annual area budget for all activities relating to all headcount, testing and maintenance activities undertaken by Registration Compliance
  • Responsible for identifying cost saving opportunities and optimization of tasks to deliver budget benefit and support departmental productivity opportunities.

    • Continuous Improvement

  • Champion and identify opportunities to develop business capability in relation to continuous improvement initiatives. Work on projects as required to implement lean initiatives and continuously improve our technical capability and conformance.
  • Provides technical support and expertise in quality related problem solving, risk analysis groups.
  • Responsible for working collaboratively with colleagues in the function to deliver sustainable solutions to drive a continuous improvement mindset.
  • Responsible for the generation and execution of the Registration Compliance Roadmap
  • Identify and deliver longer term continuous improvement project commitments.
  • Responsible for leading appropriate quality committees & improvement action plans

    • Team Management & Development

  • Responsible for managing and leading team to achieve the operational / strategic goals.
  • Accountable for driving growth within the team through individual development plans.
  • Work collaboratively with colleagues, external functions and stakeholders to deliver sustainable solutions to drive a continuous improvement mindset.
  • For any direct reports ensure all members of the team have training relevant to the tasks they are carrying out and their position within the company hierarchy. Carry out staff appraisals on an annual basis and identify any areas of weakness & further training. With reference to new employees, an appraisal must be carried out after the first 3 months of employment.

    • About You

  • English Speaking
  • Previous level 7 or several years in a level 8 at last job or equivalent in other organisations.
  • Trained in HACCP Level 3 as a minimum, ideally Level 4
  • Experience of Previously Managing Regulatory bodies / Accreditations
  • Desirable - Qualification in Internal Auditing
  • Desirable - Trained in Level 4 Food Hygiene
  • Educated to degree level in a Science-based / Food Technical degree.
  • Experience of working in a Quality environment essential
  • Experience of Manufacturing environment preferred.
  • Strong Quality Management / Improvement background advantageous
  • Relevant academic qualifications/experience
  • Significant work experience in leading teams in pharma or FMCG environment
  • Capable of working on multiple priorities and setting targets and timeframes
  • Project management skills
  • Adaptable enough to work in an environment that changes / challenges daily.
  • Ability to work in a pressurised, heavily targeted and measured environment.

    • About Us, We offer and What's next

    At Danone UK & Ireland, we are committed to delivering better health through better nutrition for millions of consumers and patients in our communities.

    We have a range of flexible benefits and excellent rewards, click here to find out more:

    Diversity, Equity, and Inclusion (DEI) is deeply embedded in Danone's DNA, representing our core values and beliefs. We embrace diversity as a driving force for positive change, nurturing an inclusive workplace where every individual is valued.

    The closing date for applications is 26th June 2024 you will therefore hear about your application after this date. We may close this role early if we receive a high number of applicants.

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