Senior Quality Associate
An exciting opportunity to lead a team of R&D Quality Associate(s) in driving site wide Quality Management System activities and support. This role is responsible for the management and oversight of the Quality Management System (QMS) in the R&D facility in line with current regulatory requirements and internal RB standards.
A fantastic opportunity is available for a Senior Quality Associate to join our Quality team.
- 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 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
- Maintains a balance of personally managing aspects of the QMS while delegating activities to the wider team where applicable
- Ensures staff in R&D are adequately trained in quality and compliance systems and procedures
- Ensure that suppliers of services, raw materials and components to R&D meet GMP and R&D standards.
- Manages resource allocation and prioritization within the team as appropriate
- Building an environment and culture that supports the core values and which enables development of key talent
- Development and maintenance of "leading edge" quality management systems in alignment with best practice in Supply and Global Quality Assurance.
- Maintains an awareness of broad activities of R&D, Marketing and Supply, integrating quality systems as required for product regulatory compliance
- Interacts cross functionally to ensure seamless launch of NPD and EPD
Is this You?
- Degree in a relevant scientific discipline e.g. Biology, Chemistry, or Pharmacy
- Preferred trained and experienced Lead Auditor
- Minimum of 5 years' experience within Healthcare/FMCG multidisciplinary environment
- Knowledge of regulatory requirements
- 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
In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organisation.
Apply Now for a chance to really change the game!
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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