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Quality Assurance Lead

vor 7 Monaten

Berlin, Deutschland ProPharma Group Vollzeit

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.

The Quality Lead position supports and oversees the internal quality program for specific clients to ensure ProPharma' s delivery of high-quality Medical Information service.

Essential Functions Include:

- Supports the delivery of the internal quality program including quality assurance and quality control by reviewing medical information calls and written enquiries.
- Performs tracking and trending of internal quality review feedback to identify trends or patterns. Provides scheduled feedback of highlighted trends to support the Manager to target training or feedback as appropriate.
- Maintains awareness of and ensures adherence to applicable SOPs/controlled documents, regulations, guidelines, and all types of client agreements.
- Contributes to the creation of controlled documents such as Working Practices and Work Instructions.
- Assists Medical Information Managers in investigating service complaints and deviations, identifying root cause and CAPAs and communicating these to the Managers.
- Collaborates with Operational and Client Services Managers to support preparation for client audits and regulatory inspections.
- Supports client audits and regulatory inspections at ProPharma, and acts as SME for quality topics.
- Develops responses to CAPAs arising from client audits and regulatory inspections at ProPharma, with support from Operations Managers, Client Services and Global Quality, and tracks to completion and closure.
- Participates in relevant client operational meetings as directed by Management.
- Proactively identifies improvement opportunities to support the continuing development of ProPharma as a leading provider of outsourced global Medical Information solutions.
- Identifies any issues which could potentially impact services and escalates any areas of concern within the business to Management, with potential corrective actions.
- Other responsibilities as may be assigned.
- B.S./B.A. preferably in life sciences or healthcare, or equivalent experience.
- Experience in Medical Information or Pharmacovigilance or experience in a QA role.
- At least C1 level German speaking, writing and listening skills and fluency in English
- Excellent attention to detail and focus on quality.
- Strong verbal and written communication skills.
- Excellent workload management skills and ability to prioritize workload and meet deadlines.
- Excellent questioning and listening skills.
- Capable of resolving conflict in a constructive manner.
- Able to work in a collaborative manner with colleagues in other departments to achieve Company goals.
- Ability to speak effectively in interpersonal situations and presentations before groups of employees and clients.
- Possesses a service-oriented approach.
- Flexible and proactive toward changing needs.
- Proficiency with use of MS Word, Excel, and PowerPoint.
- 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.