Local Quality Responsible

Recruiter / Employer: Roche Kenya
Contract: Permanent
Salary: Confidential
Status: Expired

Roche in Nairobi is seeking a Local Quality Responsible (LQR) to be responsible  for proactively ensuring that all  GCP /GVP governed activities are delivered to the Roche standard of quality  and drives compliance  in accordance with the applicable   regulatory requirements,  the  Roche OMS,  Policies  and written  procedures and industry  best practices.  The LQR establishes,  maintains and fosters relationships with key business partners across the affiliate so that the global  expectations for quality  management are met by providing efficient,  effective and value added support across the local  organization.

Key Accountabilities:

  • Leads and manages the strategic and operational  performance of the Quality Management System (QMS) at affiliate  level,  ensuring the successful  delivery  of the Global Quality  Strategy, in alignment with annual  Quality  Objectives,  whilst  maintaining  oversight and  adherence  to  local  regulatory requirements.
  • Promotes a quality culture  that ensures the highest standards of Quality  and Medical Compliance.
  • Proactively  monitors  and oversees external  regulatory changes  affecting affiliate quality  and compliance.
  • Drives the Affiliate Management Review  Process ensuring that key quality  or compliance issues are communicated effectively to senior management and appropriate actions are taken.
  • Identifies and works in partnership with  key affiliate stakeholders  and  QCCL to maintain  quality standards and to support continuous improvement   in  the Affiliate.
  • Leads the Risk Management Process for Medical  Compliance  at local level  to proactively  identify, manage and treat risks in order to support the business objectives of the local organization.
  • Drives  and enables  the overall CAPA Management process at local  level.
  • Ensures the implementation of global processes and process improvement initiatives  in their affiliate with the necessary local subject matter experts in  collaboration with the QCCL.

Strategy and Governance:

  • Ensures  the  maintenance  of  the Affiliate  Quality   Management   System  (QMS)  and  its  related documents,  in alliance with the Quality principles  outlined in the Global Roche GCP /GVP Quality Manual.Ensures that the Affiliate  QMS Handbook is  maintained on an annual basis  (annually   reviewed) and followed  by all relevant  personnel.
  • Ensures that   an annual  GCP/GVP local   Quality   Plan   is  developed   and  monitored with  Quality
  • Objectives that are aligned  with  Global  Quality objectives.
  • Drives the coordination  of the Local  Medical  Compliance  Office (LMCO),  or equivalent  committee.
  • Develops affiliate level  Quality  Report to summarize key data for senior  leadership  to take informed decisions.
  • Drives the  Management Review  Process by conducting regular  Management Reviews with the Affiliate   Leadership Team  to  report on  the quality   and  compliance   status of the  business  and demonstrate leadership   in the analysis,    trending and reporting  of key metrics  to enable informed decision making, ensuring that senior management is  pro-actively informed of systemic compliance and quality  issues/risks
  • Ensures there  is  a communication    strategy to share  information  and  key outputs from Affiliate
  • Management Review Process with the extended affiliate and the QCCL.
  • Ensures the implementation of GCP/GVP QMS requirements  for the  affiliate and monitors progress.
  • Drives and coordinates   the Affiliate   audit   and inspection  process at the local  level and is  the single point of contact for Product Development Quality (PDQ).

Organizational Effectiveness:

  • Ensures  that  a  local  training   grid   is  in place  for  all  GCP/GVP  roles  in the  affiliates and  that appropriate local  training curricular are defined and followed in collaboration   with local  stakeholders.
  • Ensures   in  a timely manner,   that local  GCP/GVP personnel  are assigned  to the appropriate global job families  to receive global  core compliance  training.
  • Demonstrates oversight of GCP/GVP Training metrics and follow-up of training  compliance where needed.
  • Supports collection   and maintenance of employee qualification  documentation (e.g.,   CVs and JDs) when applicable.
  • Monitors   the resource requirements for key functions in collaboration with  the QCCL,  CMDs and GMs to support a compliant and efficient organization.
  • Ensures that local  quality resources and any related  risks are communicated  to International Quality Management (IQM).

Processes  & Procedures:

  • Owns the local  controlled document management process and implements and maintains a local process  (where  needed)    that  describes    the  creation  and  management  of  local   procedural documents in  line with global  and local regulatory requirements.
  • Ensures  the  consistent   alignment  between  local   and  global   procedural  documents  with   local regulatory  requirements and ensures  effective  implementation.
  • Ensures  that  the  local  GCP/GVP  Controlled  Documents   are  uploaded  and  maintained  in  the Document Management System

Records  Management:

•     Ensures the records management requirements for QMS are established and followed by Affiliate according  to the Roche Global  Records  Management Directive in collaboration with the respective COREMAP representative.

Continuous Improvement:

  • Ensure that deviations  to  GCP/GVP processes are  managed  in accordance with Roche global standards.
  • Ensure  that all  applicable  affiliate   stakeholders are trained and know their  responsibilities  of the Global  CAPA processes and their responsibilities  as identifiers  of potential  deviations.
  • Facilitates the root cause analysis and impact assessment.
  • Ensures affiliate  CAPAs  (from  local   self-identified deviations/affiliate    audits and inspections)   are documented, tracked, monitored  and followed up to timely and effective closure.
  • Ensures that the Affiliate Leadership Team and the QCCL are aware of any at risk and/or overdue or ineffective  CAPAs.

Metrics

  • Drives  and implements  improvements  to quality metrics and identified   gaps in collaboration   with the business and QCCL.
  • Performs trend analysis  on data for discussion at LMCO & Affiliate management reviews with input from local  SMEs (including LSR,  Local  ORA and APT}.
  • Coordinates and facilitates the collection and review of data for the Affiliate  PASSPORT process and ensures appropriate actions are carried out and/or escalated to Local or QCCL.
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