Job
Description
Provide strategic oversight and tactical support for Document Management activities, including authoring, review coordination, approval, issuance, implementation, periodic review, and retirement of documents Ensure the performance of both routine operations and strategic initiatives related to global and local documents, as well as APQRs, continuously improves to meet compliance needs and business priorities Support the health and performance of electronic management systems in compliance with procedural guidelines Balance stakeholder needs with priorities and ensure adherence to document procedures Monitor review and approval processes to prevent deviations from global document management and health authority requirements Manage compliance gaps and deviations from global processes Develop forecasts, plans, and schedules to ensure timely document flow and completion reporting Act as a liaison with the business to ensure accurate document content and compliance with health authority regulations Provide leadership and coaching on current industry trends and quality systems management Manage risk and uncertainty, implement contingency plans, and lead the team to meet goals while resolving complex issues Use a risk-based approach to ensure compliance with procedural document regulations Develop and monitor key performance indicators to identify and mitigate risks,and collect metrics to identify trends and take appropriate action Communicate status updates to impacted business units Key Responsibilities Provide strategy, oversight and tactical support of Document Management run the business activities including document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement. Ensure performance of run the business and strategic initiatives associated to global and local documents, and APQR s continuously improve to meet compliance needs and business priorities. Support health and performance of associated electronic management systems in compliance with procedural guidelines. Manage stakeholder needs in balance to priorities and execution of document procedural adherence. Ensure up to date monitoring of review and approval ownership to prevent deviation of effectiveness for global document management and health authority requirement adherence. Manage events associated to findings of compliance gaps and deviation from global processes. Develop forecast, plan, and schedule that delivers timely flow of documents in and out of electronic system to include reporting and documenting completion as per governing procedures. Liaison with the business as the subject-matter expert to ensure accurate document content and compliance with health authority regulations and expectations. Provide leadership and coaching in relation to contemporary knowledge of current industry trends, standards, and methodologies as it relates to quality systems and management. Manage risk and uncertainty, and to anticipate the need for and implement contingency plans. Lead team to meet goals while resolving complex issues Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies. Develop, adjust, and monitor key performance indicators to identify and mitigate risk to business objectives. Monitor trends to develop continuous improvement objectives and revised contingency plans (as required) Collect metrics to identify trends and take appropriate action. Communicate up to date status to impacted business units Qualifications & Experience Bachelor of Science in Life Sciences (Chemistry, Biology) or Health Sciences. Post-graduate qualification preferred. A minimum of 7 years of pharmaceutical industry GMP experience and demonstrated leadership in Quality and/or Compliance discipline with in-depth knowledge of global health authorities regulations and requirements. Experience in a senior role with product quality complaints involving global teams and globally distributed products is required Fluent in English, with proven professional working proficiency in English for reading, writing and speaking, including the ability to deliver clear and articulate presentations Commitment to Quality
