US-TX, Vigilance Process Assurance Manager 232819BR-MZ
Vigilance Process Assurance Manager
Global Drug Development
CMO & PATIENT SAFETY GDD
Fort Worth, TX
Research & Development
Provide support assisting the Vigilance Process Assurance (VPA) Management with vigilance related quality and compliance oversight, training and continuous improvement opportunities to Global Device Vigilance (GDV) and Global Device Medical Safety (GDMS) functions and other business partners. Through risk-based audits and assessments of vigilance systems and operations, identify quality and regulatory compliance issues and support remediation initiatives. Support Audit/Health Authority inspection preparation and management activities.
Identify and communicate quality and regulatory compliance issues to GDV and GDMS management through appropriate channels. 2. Support VPA initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; and provide ongoing project support and governance, as assigned. 3. Support VPA initiatives focused on quality, process and compliance improvement. Through collaboration with business partners, identify opportunities for improvement and develop strategies aimed at simplifying processes and improving quality of outputs while ensuring compliance with regulatory requirements. Support with compliance investigations and initiatives focused on inspection readiness. 4. Act as a change agent for leading and managing continuous improvement processes while instilling a culture of accountability. 5. Support continuous improvement events resulting in employee skill and knowledge development and KPI performance improvement. 6. Review, evaluate and support proposed corrective and preventative action plans (CAPA). Monitor and track status of corrective and preventative actions to ensure the issues are adequately addressed and completed. 7. Support Audits and Health Authority inspections; assess results of pre-audit/inspection preparation activities and Audit/HA inspection observations/findings in terms of associated risks and communicate to management; provide input to CAPA to ensure quality, consistency and appropriateness of commitments. Interface and communicate with auditors/regulatory authority representatives as required. 8. Assist with information gained during initiatives focused on compliance and quality improvement, as well as audit and assessment results, to identify specific regulatory, compliance and quality assurance training needs for business partners 9. Review and support on relevant global guidelines, policies, Novartis Internal Procedures (NIPs) and SOPs (Standard Operating Procedures). 10. Author/Assist with SOPs and work instructions relevant to job functions 11. Educate, coach, train team members on relevant vigilance procedures 12. Proactively research and monitor local and global initiatives, trends and events that impact maintenance of compliance as well as changes to global vigilance regulations, guidelines, policies and procedures. Lead initiatives with business partners to ensure adequate integration into business practices.
Timely, complete and effective communication, consultation and support to business partners. 2. Timely escalation through proper channels of issues and findings that impact on Alcon s vigilance and risk benefit evaluation capabilities. 3. Effective collaboration on quality/compliance remediation and improvement initiatives. 4. Implementation of training programs that meet the needs of business partners and improve overall quality and compliance. 5. Timely review and feedback on policies, guidelines and procedures. 6. Successful implementation of process and system improvement projects 7. Sustained process improvements.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
BA/BS or equivalent in a healthcare or science discipline
* Advance degree desirable English 3-5 years relevant work experience (i.e. device/drug safety, compliance, quality assurance, regulatory affairs); auditing experience a plus;
* Ability to identify and objectively evaluate compliance is-sues; Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision making and problem solving;
* Experience with Health Authority inspections and interac-tion;
* Good quality and compliance leadership and facilitation skills;
* Excellent verbal and written communication, organizational and interpersonal skills; Excellent computer skills, including Excel, Word, etc;
* Thorough knowledge of applicable Regulatory , GMP and GDP guidelines, policies and procedures;
* Good knowledge of computer validation and Part 11 re-quirements;
* Ability to operate successfully in various team capacities, including leader and/or active member;
* Ability to operate successfully in various cultural environments.
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