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Salary For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Position overview
The Senior Quality Specialist position supports the delivery of Medical Information and Pharmacovigilance services, to assure ongoing compliance with quality and industry regulatory requirements. The Senior Quality Specialist performs improvement activities through continuous monitoring and evaluation of the quality system to ensure ongoing maintenance.
Essential Functions
- Assisting with the planning, coordination and development of QA procedures, programs, and projects. Hosting or co-leading and facilitating client audits
- Generate and prepare reports to communicate outcomes of quality activities.
- Analyze and investigate, Deviations and Quality Events to identify areas for improvement in the quality system.
- Supports the delivery, co-ordination, and planning of Quality Assurance program (as applicable to line of business, this might include ad hoc process audits, call monitoring reviews etc.)
- Review, approve, and communicate root cause and corrective action to stakeholders.
- Develop, recommend, and monitor corrective and preventive actions.
- Tracks documentation, as necessary.
- Collection, management, and analysis of data related to CAPAs, Deviations and quality KPIs.
- Record, track, and trend audit findings and response times.
- Deliver root cause and corrective actions to stakeholders
- Support the Quality Manager during external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data.
- Perform effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs.
- In conjunction with the Quality Manager, conducts routine Pharmacovigilance audits.
- Supports and facilitates eQMS activities (i.e. Document Management, QA review and approvals, Change Control assessments, etc.)
- Leads QA projects as needed.
- Provide guidance on applicable legislation
- Other duties as needed
Skills required
- University/Bachelor’s degree and/or or appropriate relevant work experience
- Minimum 8-10 years’ experience working in a Quality Assurance role within the Life-Sciences sector
- Exposure to Deviation’s; CAPAs; supporting or conducting audits
- Able to take on work as a stand in for key leadership personnel when necessary
- Fluent in English
- Strong stakeholder management skills are a must
- Happy to work remotely but some travel to ProPharma sites maybe required when critical
- Thorough, dedicated and detail orientated
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
