US-TX, Senior Manager, Vigilance Process Assurance 220609BR-MZ
Senior Manager, Vigilance Process Assurance
Global Drug Development
CMO & PATIENT SAFETY GDD
Fort Worth, TX
The Senior Manager, Vigilance Process Assurance, provides device vigilance related quality and compliance oversight, training and continuous improvement opportunities to Medical Safety and other business partners; and collaborate across sectors, functions, and with Alcon regional offices to share lessons learned and identify and communicate potential gaps. Through risk-based audits and assessments of Post Market Surveillance systems and operations, the Senior Manager identifies quality and regulatory compliance issues and leads remediation initiatives. The Senior Manager will also lead Health Authority inspection preparation and management activities.
1. Identify and communicate quality and regulatory compliance issues to Global Post Market Surveillance management through appropriate channels.
2. Lead initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; and provide ongoing project support and governance, as assigned.
3. Lead initiatives focused on quality, process and compliance improvement. Through close 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 in-stilling a culture of accountability.
5. Lead and support continuous improvement events resulting in employee skill and knowledge development and KPI performance improvement.
6. Independently review, evaluate and support proposed corrective and preventative action plans (CAPA). Monitor and track status of corrective and preventative actions to ensure that issues are adequately addressed and completed.
7. Lead and support cross-sector and cross-functional projects.
8. Review inspections across sectors to determine lessons learned and communicate to area presidents and regional Medical Safety personnel to identify potential gaps.
9. Prepare for and facilitate Health Authority inspections; assess results of pre-inspection preparation activities and HA inspection 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 regulatory authority representatives as required.
10. Independently evaluate 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. Lead the development, implementation and conduct of appropriate training.
11. Review and support on relevant global guidelines, policies, Novartis Internal Procedures (NIPs) and SOPs (Standard Operating Procedures).
12. Author SOPs and work instructions relevant to job functions
13. Educate, coach, train team members on relevant post-market procedures
14. 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 in-to business practices.
15. Utilize professional competence to support Medical Safety with compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement. Analyze root causes for non-compliance through process review. Formally document outcomes.
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.
Education: BA/BS or equivalent Advance degree desirable
Languages: English fluency at operational and functional level
5-7 years PV/clinical/industry/health authority experience; auditing experience a plus;
Experience with leading teams in a highly regulated environment
Ability to manage and objectively evaluate compliance issues;
Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a high degree of independence with respect to decision making and problem solving;
Experience with Health Authority inspections and interaction;
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 requirements;
Ability to operate successfully in various team capacities, including leader and/or active member;
Ability to operate successfully in various cultural environments;
Auditor certification a plus.
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