Senior Quality Assurance Manager
Senior Quality Assurance Manager
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1 Vacancy
Job Description
Position Summary - Summary of Key Responsibilities
The Senior Quality Assurance Manager ensures continuous quality improvement through effective management and oversight of Audits and Inspections. Facilitates ongoing quality improvement measures through communication of audit & Inspection intelligence and compliance guidance/training. The Senior Quality Assurance Manager leads educates mentors and develops the team within the function to ensure their competence and confidence in developing to become subject matter experts. The Senior Quality Assurance Manager ensure that reporting review and analysis of Findings from Audits and Inspection and CAPAs is performed efficiently and in compliance with global regulations legislation and PrimeVigilance requirements.
Roles and Responsibilities
Leads a team which manage audit and inspection findings and observations and their associated corrective and preventative action plans (CAPAs) Manages and maintains the electronic quality management system (EG-QMS) Audits module -CAPA Management. Performs periodic trending of Findings across the company providing insights into the potential causes of trends to operational and quality management.
Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team. Participates in audits and inspections including document request provision front and back-room activities and follow-up of audit and inspection findings and completion of client questionnaires and RFP/RFI
Acts as a Subject Matter Expert and client point-of-contact for Quality including attendance at operational and quality governance meetings. Collaborates and guides operational personnel to ensure effective root cause analysis and writing/delivery of appropriate CAPA Plans and develops and delivers training on these topics and other quality topics Generates metrics on CAPA compliance for Global Quality Council Quality Leadership Senior Leadership and Management review purposes.
Assists in the development maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP US FDA CFRs JMPA and ICH-E6.
Conducts other ad hoc activities as requested by Director Quality Assurance and/or VP of Quality.
Specified Additional Responsibilities
Procedural creation management revision
Training
Analysis and reporting of quality related data.
Effective operational line management of direct reports. Ensures the timely delivery of
Performance reviews and discussions including annual appraisals
Absence approval management and resource planning
Ensuring adequate cover is in place to meet operational requirements for existing and new contracts
Mentoring and training aligned to development needs and career aspirations of direct reports within the department
Qualifications :
- A university degree in a healthcare discipline or equivalent scientific area
Substantial experience in pharmaceutical/biotechnology pharmacovigilance with a in depth understanding of GVP/GCP-related Quality Management and Assurance
Sound knowledge of international regulations related to Pharmacovigilance and Medical Information
Experience of participating in audits and inspections
Ability to lead mentor and develop teams
Excellent communication and facilitation skills within a global organization
Proactive and self-motivated with strong organizational and planning abilities
Excellent problem-solving and decision-making skills
Attention to detail and commitment to high standards
Ability to analyze data and prepare detailed reports
Knowledge of quality management principles and practices
Additional Information :
We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly supportive working environment
- Opportunity to work with colleagues based all over the world with English as the company language
Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
Company Industry
Key Skills
- Continuous Integration
- Quality Assurance
- FDA Regulations
- Root cause Analysis
- TFS
- Food Processing
- ICH Q10
- Jira
- Software Testing
- Quality Management
- Selenium
- Github
