Full-Time Senior Manager of Quality Management

Senior Manager of Quality Management is responsible for leading teams within Quality Management, aligning with global strategic objectives. Collaborates with global operational functions to ensure Pharmacovigilance and Medical Information activities comply with GVP regulations, ICH, and PrimeVigilance requirements.

Leads, educates, mentors, and develops the Quality Management function to ensure competence and subject matter expertise.

Ensures assigned Quality Management System activities are managed in compliance with regulations, company policies, and agreements.

Maintains oversight of departments to ensure quality of PrimeVigilance’s Pharmacovigilance and Medical Information activities are compliant with regulations, fulfilling clients' Sponsor and Marketing Authorisation Holder Obligations.

• Deviations, non-conformities, and issue management: Supports operational departments in assessing, reporting, and addressing deviations, non-conformities, and issues within timelines.
• Elevating issues: Reports serious/systemic issues with recommendations to senior leadership for resolution.
• Trending data: Analyzes deviation, issue, and compliance data for risk mitigation recommendations.
• Controlled Procedures: Oversees status and quality of controlled procedures.
• Training: Oversees training compliance and manages training related to Quality Management.
• Electronic Quality Management System: Oversees assigned system areas, maintains the system, provides user administration and support, manages and tests the Business Continuity Plan, and manages system changes.
• Audits and Inspections: Supports audits and inspections as a Subject Matter Expert.

Qualifications:

• Life science, pharmacy, nursing or healthcare-related qualification
• Demonstrated line management experience
• Pharmaceutical/biotech Pharmacovigilance experience
• Understanding of GVP, Quality Management and Assurance
• GxP Knowledge: In-depth knowledge of applicable GxP regulations and ICH Guidelines.
• Auditing Knowledge: Advanced knowledge in conducting and reporting audits and translating findings into corrective action plans.
• Certifications: ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, SQA Registered Quality Assurance Professional, Quality Management Systems Auditor/Lead Auditor (ISO 9001), or similar.
• Negotiation Skills: Proficiency in negotiation and conflict resolution.
• Pharmacovigilance Development: Understanding of Pharmacovigilance development program phases, processes, and techniques.
• Product Knowledge: Understanding of medical/therapeutic impact of products.
• Scientific Knowledge: Necessary science education and knowledge for quality management and assurance.
• Communication Skills: Professional, clear, concise, consistent communication to internal and external customers, verbal and written. Presentation skills.
• Project Management: Proficiency in managing complex projects, delivering deliverables on time, and communicating changes to deadlines.
• Organizational Skills: Prioritizing work effectively, managing tasks, delivering on time, and communicating changes to deadlines.

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