Quality Lead (REMOTE)

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. 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, operating in a multifaceted function, by working with and supporting various operational teams. The Quality Lead performs quality activities as outlined in ProPharma's Quality Policy and procedures. Serves as the central regional point of control for 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 relevant stakeholders.

· Collaborates with Operational and Client Services Managers to support preparation for client audits and regulatory inspections.

·  Acts as host or supports client audits and regulatory inspections as needed 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.

·  Supports the Quality Manager in the Regional Quality Committee meeting and acts as a regional representative in the Global Quality Committee.

· Proactively identifies improvement opportunities to support the continuing development of ProPharma

· Identifies any issues which could potentially impact services and escalates any areas of concern within the business to Management, with potential corrective actions.

·  Supports the achievement of internal compliance Key Performance Indicators.

Other responsibilities as assigned.

Necessary Skills and 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, preferably related to cGxP.

Educational Requirements:

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

Experience Requirements:

• 5 years' Quality experience in pharmaceutical or medical device industries or other regulated industries (i.e., healthcare).
• Previous experience of data mining, analysis, and presentation.
• Previous audit experience acting as QMS SME preferred.
• Pharmacovigilance QA experience: Experience contributing to Pharmacovigilance System Master File (PSMF) maintenance preferred.

#LI-mk1 REMOTE