Full-Time Senior Manager Quality Management

Senior Manager of Quality Management leads one or more teams within Quality Management, aligning with global objectives.

Collaborates with operational functions to ensure Pharmacovigilance and Medical Information activities comply with GVP regulations, ICH guidelines, and PrimeVigilance requirements.

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

Role and Responsibilities

• Manages Quality Management System activities in compliance with regulations, policies, and agreements.
• Oversees departments within Quality Management, ensuring quality of Pharmacovigilance and Medical Information activities meet regulatory requirements and client obligations (Sponsor and Marketing Authorisation Holder).
• Manages deviations, non-conformities, and issues, supporting operational departments in assessment, reporting, and resolution.
• Elevates serious/systemic issues to senior leadership with recommendations.
• Trends deviation, issue, and compliance data, developing risk mitigation recommendations.
• Controlled Procedures: Maintains oversight of controlled procedures' status and quality.
• Training: Manages training compliance and training relating to Quality Management.
• Electronic Quality Management System: Oversees system areas, assists in maintenance, provides user administration and support, manages and tests the Business Continuity Plan, and manages change management of controlled systems.
• Audits and Inspections: Supports audits and inspections as a Subject Matter Expert for the Quality Management department.

Qualifications

• Life science, pharmacy, nursing, or other healthcare-related qualification.
• Demonstrated line management experience.
• Pharmaceutical/biotech pharmacovigilance experience with understanding of GVP-related Quality Management and Assurance.
• GxP Knowledge: In-depth knowledge of applicable regulations and ICH guidelines.
• Auditing Knowledge: Advanced knowledge in conduct, reporting of audits, and translating findings into corrective actions.
• Certifications: ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence, SQA Registered Quality Assurance Professional, or similar.
• Quality Management Systems Auditor/Lead Auditor (ISO 9001)
• Negotiation Skills: Proficiency in negotiation and conflict resolution.
• Pharmacovigilance Development: Understanding of phases, processes, and techniques.
• Product Knowledge: Understanding of medical/therapeutic impact of products.
• Scientific Knowledge: Necessary science education to manage quality oversight.
• Communication Skills: Professional, clear, concise, and consistent communication.
• Project Management: Proficiency in managing complex projects, timely delivery of deliverables, and proactive communication.
• Organizational Skills: Effective prioritization to meet timelines.

Company Values: Diversity, Equity, and Inclusion, creating an equal opportunity workplace and a human-centric environment.

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