Sr. Quality Associate R&D

R&D Senior Quality Associate

Reporting to the R&D Quality Manager this role is responsible for the management and oversight of the Quality Management System (QMS) in the R&D facility locally in line with current regulatory requirements and internal RB standards and requirements. The role may lead a team of R&D Quality Associate(s) supporting routine Quality Management System activities on the site depending on the activities conducted on that site.

Responsibilities/Accountabilities


  • Ensures that the local Quality Management System meets current regulatory requirements and RB internal standards as defined within the RB Business Management System (BMS)

  • Ensures RB policies are implemented within local SOPs within the local QMS as appropriate

  • Ensures that there is an appropriate and systematic approach in place for the quality approval of documents such as batch manufacturing records, Standard Operating Procedures, deviations, change controls, risk evaluation and management documents, validation documents and other quality related records as defined within the local QMS

  • Develops and manages an annual internal audit program for the site to verify and improve the effectiveness of the of the operational quality management system

  • Ensures that there is a system in place that manages the assessment, audit and approval of external GMP suppliers and service providers used during the development process

  • Maintains an approved supplier list for the facility locally or as part of a global system and ensures Technical Agreements are in place and are reviewed as per internal RB requirements

  • Maintains and communicates performance of the QMS via the agreed Quality Key Performance Indicators - to ensure deviation, change controls and out of specifications are handled to a high standard in appropriate timeframes

  • Schedules and leads the Management review for the site

  • Manages the quality release function for the site supporting Clinical Trials (Hull only)

  • Manages the quality release function supporting Consumer trials locally and as appropriate. Ensures that the systems that in place locally are aligned with the R&D quality release systems in Hull.



  • Manages the annual GMP quality improvement action plan for the facility and ensures quality improvement initiatives are assessed and implemented promptly and effectively



  • Ensures a system is in place to deliver GMP Induction and refresher training and that training on key quality systems and principles is also provided to the R&D Teams locally



  • With the R&D Category Teams, ensures that the t echnical t ransfer of projects are completed and consistent with satisfactory handover to manufacturing and launch to the market

  • Provides quality input and approval of software validation, including major systems impacting R&D

  • Ensures that key quality documents are kept up to date for example Site Master File, IMP Manufacturing Authorisation as appropriate



  • Responsible for the development of his/her team members to enable them to achieve their full potential



  • Proactively monitors and ensures the facility has plans in place to respond to changes in guidance and legislation issued by Regulatory Authorities

  • Leads the preparation for and actions arising from inspections by Regulatory Authorities/Notified Bodies

    Key Challenges





  • Interacts cross functionally to ensure seamless launch of NPD and EPD


    Professional Qualifications Experience


    • Degree in a relevant scientific discipline e.g. Pharmacy, Biology or Chemistry

    • Qualified or in training to be an EU QP, eligible to assess and release IMPs for Clinical studies - UK based role requirement

    • Trained and experienced Lead Auditor

    • Minimum of 5 years' experience within Healthcare/FMCG multidisciplinary environment

    • Pharmaceutical sector quality system design and implementation experience including OTC/Monograph drug, Medical Device and Computer System Validation

    • Broad knowledge of regulatory requirements at an international level

    • Intimate understanding of the product life cycle including R&D, Manufacture and Distribution

    • Experience with recruitment, management and development of people

    • Results oriented, entrepreneurial and self-motivated, with solid planning and organisational capabilities, a bias for action, and the capability to define and evaluating and communicating risks

    • Good leadership, motivational and interpersonal skills

    • Global mindset, commercial understanding of corporate and operational business issues

    • Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action

    • Excellent communication skills, both written and oral

    • Proven ability to work under pressure without compromising on deliverables

    • Capable of building strong working relationships and motivating teams to deliver outstanding results with or without hierarchical relationships

    • Commercial understanding of corporate and operational business issues


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