Director, Quality Management

ROLE SUMMARY

The Director, Quality Management will report to the Senior Director, Head of Quality Management and will collaborate with colleagues, customers, and stakeholders across the organization providing direction and strategy for all inspections involving WMS deliverables.

As the Director of Quality Management, you will lead global inspection readiness activities within WSR and liaise with quality groups outside of WMS to promote global inspection readiness. Ensure inspection readiness by applying previous inspection learnings and ensuring previous commitments have been met, including ongoing inspection and audit commitment tracking and CAPA management. Lead SQE evaluation and assessment procedures and subsequent CAPA management. Lead the evaluation of relevant WSR processes, look for opportunities for improvement and provide direction and strategy in support of inspection readiness.

ROLE RESPONSIBILITIES

• Set vision and strategy for inspection and audit readiness worldwide and provide direction through policy/procedure development and deployment, including training.

• Acts as a contact and resource for WSR globally during regulatory inspections by competent authorities including facilitating interviews with appropriate Subject Matter Experts (SMEs) and assist colleagues during the course of inspections and audits.

• Actively support PV inspections and external audits and help to make PV inspections a success, by providing effective and efficient preparation and timely turnaround of inspection requests. Supports the tracking of inspection commitments to completion ensuring timelines are met.

• Assist or lead the coordination of internal audits of WSR by assisting in the creation of the audit plan, agenda and facilitating appropriate business line SMEs. 

• Assisting WSR business SMEs in appropriate audit remediation plans and tracking all actions to completion.

• Assists with/leads the preparation and communication of audit report findings including periodic trend assessments.

• Assists/generates, analyzes and reports PV scorecard to management to transparently show important aspects of the PV compliance status.

• Serves as SME and collaborates with quality groups external to WSR who will coach colleagues within CMO and country operation locations in international pharmacovigilance to prepare for internal/external audits and regulatory inspections.

• Participate in the identification of Qualifying Quality Issues, and ensure corrective/preventive action (CAPA) plans in response to Safety and Regulatory QQIs, audits, and inspections and ensure that commitments are met in a timely manner.

• Collaborates across the organization to facilitate the drafting of CAPAs in response to audits and inspections and ensures that commitments are met in a timely manner. Assesses ongoing compliance of the CAPAs submitted to regulatory agencies, identifies gaps and brings into compliance.

• Acts as the SRQ partner to facilitate progress and close CAPAs and commitments arising from regulatory inspections and internal audits, as appropriate.

• Evaluates audit/inspection reports from various sources (e.g., regulatory agencies, other company quality groups) to identify issues of significance and report trends.

• In collaboration with Standards and Training, develops and updates documents (SOPs, business procedures) relating to relevant procedures managed within SRQ.

• Partner with SRQ stakeholders to ensure consistency and inspection readiness of documents i.e. quality manual, WI prepared by SRQ.

• Participates in/facilitates a continuous improvement process to optimize the PV quality system and keep it current, based on applicable worldwide regulations.

• Facilitates/leads the development of inspection readiness tools and supports the implementation of the PV inspection readiness program.

• Serves as a consultant to business partners and contributes in building positive and value-added relationships with all stakeholders and helps these stakeholders create strategies to respond to regulatory findings and other requests from regulatory authorities.

• Maintains knowledge of current PV regulations by attending external training sessions, etc.

• Solicits feedback from customers and stakeholders to continuously improve pharmacovigilance compliance function deliverables.

• Monitors new regulatory legislation or guidelines, which have a direct impact on pharmacovigilance regulatory compliance function, and disseminates this information to members of other functional areas, where appropriate.

• Participates on/leads cross functional teams to execute process improvemen