Senior Manager of Quality Management

PrimeVigilance

Granitsa, Bulgaria

Job Description

The Senior Manager of Quality Management is responsible for leading one or more teams within Quality Management in line with global strategic objectives. The Senior Manager of Quality Management collaborates with global operational functions to ensure Pharmacovigilance and Medical Information activities are conducted in compliance with GVP regulations, the International Conference on Harmonization (ICH) and PrimeVigilance requirements. The Senior Manager of Quality Management leads, educates, mentors and develops the Quality Management function to ensure their competence and confidence in developing skills to become subject matter experts.

Role and Responsibilities

The Senior Manager of Quality Management has a managerial position responsible to ensure that assigned Quality Management System activities are managed in compliance with regulations and company policies and in accordance with any agreements;
The Senior Manager of Quality Management maintains oversight of one or more departments within the Quality Management function to ensure that the quality of PrimeVigilance’s Pharmacovigilance and Medical Information activities are in compliance with applicable regulatory requirements, and that its clients’ Sponsor and Marketing Authorisation Holder Obligations are fulfilled. This may include but is not limited to the following:
Deviations, non-conformities and issue management:
- Supporting PrimeVigilance operational departments in assessing, reporting and addressing deviations, non-conformities and issues within timelines mandated by PrimeVigilance procedures;
- Elevating serious and/or systemic issues with appropriate recommendations to Senior Leadership for immediate and long-term resolution;
- Trending deviation, issue and compliance assessment data for discussion and agreement of recommendations for risk mitigation.
Controlled Procedures:
- Maintaining oversight of the status and quality of applicable PrimeVigilance controlled procedures.
Training:
- Maintaining oversight of training compliance;
- Managing training relating to Quality Management responsibilities.
Electronic Quality Management System:
- Oversight of assigned areas of the system and assisting in maintaining the system;
- Providing user administration and support;
- Managing and testing the Business Continuity Plan for the system.
Change management of controlled systems:
- As required reviewing and assessing changes and upgrades to the system.
Audits and Inspections:
- Supporting audits and inspections of PrimeVigilance as a Subject Matter Expert for the PrimeVigilance Quality Management department.

Qualifications

Life science graduate, pharmacy, nursing or other healthcare related qualification;
Demonstrated line management experience;
Extensive applicable pharmaceutical and/or biotech pharmacovigilance experience with a solid understanding of GVP-related Quality Management and Assurance;
GxP Knowledge: In-depth knowledge of the applicable GxP regulations and ICH Guidelines;
Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity;
ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, SQA Registered Quality Assurance Professional or similar recognised professional status, Quality Management Systems Auditor/Lead Auditor (ISO 9001);
Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution;
Pharmacovigilance Development: Understands the phases, processes and techniques used to execute a Pharmacovigilance development program;
Product Knowledge: Understands the medical/therapeutic impact of products;
Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality management and assurance oversight
Communication skills: Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions;
Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines;
Organizational skills: Must be able to prioritize work effectively to meet timelines;
Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.