Medical Quality Manager Location Karachi, Pakistan Category Quality Job Id 202204-116838 Apply Now Back to search results Previous job Next job Apply Now JOB DESCRIPTION PURPOSE The Local Quality Responsible (LQR) is 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 QMS, 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.
DETAILED RESPONSIBILITIES1) 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).
2) 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).3) 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 4) 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.
5) Continuous Improvement : a. CAPAEnsure 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.b.
MetricsDrives 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 DRA 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.
c. Service ProvidersOversees the GCP / GVP service provider management process by liaising with key stakeholders to ensure that oversight plans are in place, performance of the vendor is regular monitored and accurate and regular risk assessments are completed & documented and actions taken where required.
ADDITIONAL RESPONSIBILITIES1) Medical GovernanceEmbed the medical governance framework in the affiliateEnsure successful implementation of Symphony guide, Global model on Interactions with Healthcare Professionals and Healthcare OrganizationResponsible for overall compliance of Medical Internal Review process to ensure all medical activities / documents are aligned with company policies, local regulations and lawsProvide oversight and guidance to Medical and Commercial teams to support Roche’s commitment to the highest standard of ethical compliance in both internal and external communicationCoordinate within medical and other department to achieve medical strategyBe knowledgeable in the specific disease area and drugs development and good understanding of brandsDevelopment of effective interactions with Clinical Operations, including but not limited to placing studies, provide input on feasibility, sites and investigators selection.
Grant, Sponsorship and Donation (GSD) CoordinatorHealthcare Compliance Monitor2) Affiliate Publication Lead Affiliate point of contact for Scientific Credibility Standards for Evidence Generation (GOV-0100109), Roche Publication Policy (GOV-0100075) and the Cross-functional Business Process for Affiliates (XBP-0100083) and to ensure that these policies are followed in the affiliate.
Collaborate with affiliate stakeholder to ensure that scientific evidence generated by or on behalf of Roche and intended to be used to inform external bodies and / or for publication in peer reviewed journals or at scientific congresses, follows defined standards of publication planning and execution for scientific integrity & credibility.
Liaise with the LQR to ensure that all roles in the affiliate that are involved in the generation of evidence (based on either primary or secondary use of data) and its use to communicate to external bodies are trained to both the scientific credibility standards and publication policies3) Country Alerting Rules ResponsibleEnsure that minimum country safety reporting requirements are reflected in the Country Alerting Rules (CAR) in line with Global : Safety Document Distribution (SOP-0113120)Conduct a periodic review of the CAR in the safety document distribution portal.
Verify Country Alerting Rules by consulting Local Regulations and with Local Regulatory, Drug Safety and Health Authority, if required.
Perform periodic review result into safety document distribution portal. Update the CAR, as required, if country requirements change.
4) Patient Access Integrated Registry and Supply (PAIRS) Country RepresentativePossesses a holistic view of processes for Pre-Approval Access (PAA) / Compassionate Use (CU) and Post Trial Access (PTA) programs in the countryServes as SME / SPOC for all local questions around the PAIRS PortalEnsures data quality and process Key Performance Indicators (KPIs) are metLeads the local PAIRS rollout and facilitates the onboarding of new local users Facilitates and improves local PAA / CU and PTA program processes OTHER RESPONSIBILITIES1) Safety ReportingAttends / completes initial and periodic drug safety training as per Roche requirements to ensure that you have a clear understanding of your role in ensuring Roche meets its obligations in respect to management of safety informationIdentifies, collects a