Regulatory Compliance Manager - Inspection Readiness

Regulatory Compliance Manager - Inspection Readiness Principal Regulatory Compliance Manager is responsible for establishing and maintaining robust Compliance Programs at the designated sites in order to ensure compliance to local, national and international regulatory requirements, company policies and procedures and corporate requirements. The Principal Regulatory Compliance Manager will be a member of the Regulatory Compliance teams, will work with Quality Operations leads of the designated CSS sites and with the Regulatory Compliance teams of other regions and business groups. The Principal Regulatory Compliance Manager is expected to collaborate with other groups within the Regulatory Compliance organization to support execution of independent audits and special assessments and deploy compliance initiatives. 1. External Inspection Readiness and Associated Activities a. Prepare and host external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, Corporate Audits for site, responsible for effective regulatory agency inspections. b. Audit preparation activities (auditor logistics, front room/back‑room arrangements, etc.). c. Assess the risk and applicability of audit observations from other facilities to determine impact to the site. d. Schedule and manage mock inspections as part of External Inspection Readiness activities. e. Provide timely information to support the inspection process, including those that may be taking place at other sites / locations. 2. Internal Audit Program and Management Execution a. Establish and execute an effective internal audit schedule for site. b. Execute against established internal audit procedures. c. Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on‑time completion of CAPA plans, perform follow‑up with CAPA owners, and perform effectiveness monitoring and closure. d. Drive compliance and improvement in internal audit metrics. e. Participate in audits as requested. f. Where appropriate assure representation on all required business unit, sector, and/or enterprise teams (e.g., Do it Right). g. Support the creation and effective deployment of internal Quality System and/or Compliance standards. h. Connect and collaborate with other compliance teams. 4. Metrics Collection and Reporting a. Assure that Quality & Compliance metrics are consistently and accurately captured, and that metrics are captured at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain). b. Drive compliance to Quality and Compliance metric targets. c. Create reports and communicate performance against metrics to key stakeholders. d. Highlight/communicate adverse trends in metrics and take risk-based action to remediate. 5. Escalations a. Escalate items in accordance with established procedures. b. Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives. c. Responsible for the proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business. 6. External Standards and Regulations a. Proactively assess and influence the external environment by participating on industry and regulatory body work teams. As appropriate collect and provide site input. Communicate outcomes and trends to key stakeholders. b. Support implementation of new external standards/regulations. c. Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings. 7. Site Management Review a. Provide input into Quality System Management Reviews (e.g. internal audits) to allow meaningful review their tasks. b. Proactively communicate organizational and compliance procedure/ policy related changes that may impact sites. Ensure feedback and alignment with said changes. c. Establish strong connection and collaboration with business partners at the site, e.g. Quality Operations, Training, Manufacturing. #J-18808-Ljbffr ALKU