Quality Lead

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 is responsible for driving positive change and process improvement in the assigned region. This role functions as an independent and objective entity and operates in a multifaceted function by working and supporting various operational teams. The Quality Lead performs quality activities as outlined in ProPharma Group’s Quality Policy and procedures. Serves as the central regional point of control for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Develops, manages, and executes quality management processes to ensure quality standards are maintained and compliant with regulatory requirements.

Essential Functions:

• Maintains awareness of and ensures adherence to applicable SOPs/controlled documents, regulations, guidelines, and all types of client agreements.
• Serves as control point for SOPs/controlled documents and Quality Management System documents.
• Contributes to the creation of controlled documents such as SOPs and Work Instructions.
• Supports the delivery of the internal quality program including quality assurance and quality control.
• Assists 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.
• Acts as host for client audits and regulatory inspections at ProPharma Group, and acts as SME for quality topics.
• Develops responses to CAPAs arising from client audits and regulatory inspections at ProPharma Group, 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.
• Supports the Quality Manager in the Regional Quality Committee and acts as a regional representative in the Global Quality Committee.
• Proactively identifies improvement opportunities to support the continuing development of ProPharma Group 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

Necessary Skills & Abilities:

• Excellent attention to detail and focus on quality.
• Strong verbal and written communication skills.
• Excellent workload management skills.
• 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.
• Good understanding of quality assurance regulations and guidelines preferably related to cGxP.
• Quality Assurance experience in internal and external audits, and maintaining regulated documents and training files, preferable related to cGxP.
• Knowledge of FDA regulations for adverse event and product complaint reporting.
• Proficiency with use of MS Word, Excel, and PowerPoint.

Educational Requirements

• University/Bachelor’s degree and/or or appropriate relevant work experience.

Experience Required

• 5 years’ Quality experience in pharmaceutical or medical device industries or other regulated industry (i.e., healthcare).
• Previous experience of data mining, analysis, and presentation.
• Previous audit experience preferred.