Quality Consultant

QA Resources Ltd; Ireland; On-site; EUR 90,000 - 120,000; Full time

Job summary

QA Resources is seeking an experienced Senior Quality professional to support the growth of our Life Sciences business in Ireland. The role combines senior technical leadership in Quality, QMS and regulatory compliance with developing and converting new business opportunities across pharma, biotech, medical devices and related sectors.

The successful candidate will act as a trusted quality advisor to clients while also developing strategic relationships, shaping solutions and contributing to

Qualifications

• Senior experience in Quality/Regulatory consulting in Life Sciences.
• Strong understanding of GxP and regulated Quality Management Systems.
• Experience working with pharmaceutical, biotechnology, medical device, diagnostics, CDMO or related Life Sciences organisations.
• Demonstrable experience developing or improving QMS frameworks and quality processes.
• Strong understanding of regulatory expectations and inspection/audit environments.
• Proven experience engaging with senior client stakeholders.
• Demonstrable business development, sales, account management or commercial consulting experience.
• Ability to translate technical Quality requirements into commercially relevant business solutions.
• Excellent communication, presentation, negotiation and relationship-management skills.
• Strong commercial awareness and ability to identify and develop new opportunities.
• Ability to operate credibly with both technical Quality professionals and senior business executives.

Responsibilities

• Provide senior Quality leadership and governance for client engagements.
• Advise on design, implementation, remediation, and improvement of Quality Systems.
• Lead quality transformation and improvement programmes for Life Sciences clients.
• Assess QMS frameworks for gaps, risks and opportunities.

Skills

Quality leadership

Quality Systems

GxP

Regulatory compliance

Quality Assurance

Client relationship management

Business development

Commercial consulting

Stakeholder engagement

Audits & inspections

Data integrity

Education

Life Sciences degree

Quality qualification (ASQ/CQI)

Job description

Role Overview

QA Resources is seeking an experienced Senior Quality professional with strong commercial and business development capability to support the growth of our Life Sciences business.

The role combines senior technical expertise in Quality, Quality Management Systems (QMS) and regulatory compliance with responsibility for identifying, developing and converting new business opportunities across the pharmaceutical, biotechnology, medical device, and broader Life Sciences sectors.

The successful candidate will act as a trusted quality and compliance advisor to clients, while also developing strategic customer relationships, identifying opportunities, shaping solutions and contributing to revenue growth.

Key Responsibilities

Quality & Quality Systems Leadership

• Provide senior-level expertise in Quality Management Systems, GxP, regulatory compliance and quality assurance.
• Advise clients on the design, implementation, remediation, optimisation and continuous improvement of Quality Systems.
• Lead or support quality transformation and improvement programmes across Life Sciences organisations.
• Assess existing QMS frameworks and identify gaps, risks and opportunities for improvement.

• Provide expertise across areas such as:

• GMP / GDP / GCP / GLP, as applicable
• Quality Management Systems
• Deviation, CAPA and Change Control
• Risk Management
• Document and Training Management
• Supplier and Vendor Quality
• Audit and Inspection Readiness
• Quality Metrics and Management Review
• Data Integrity
• Computerised Systems / CSV / CSA, where applicable
• Regulatory compliance and remediation
• Lead or participate in client audits, internal audits, regulatory inspection preparation and quality assessments.
• Provide senior oversight and quality governance for consulting and delivery engagements.
• Maintain awareness of evolving regulatory expectations and industry best practices.

Business Development & Commercial Growth

• Develop and execute business development strategies focused on the Life Sciences sector.
• Identify, qualify and develop new opportunities with pharmaceutical, biotechnology, medical device, diagnostics and other Life Sciences organisations.
• Build and maintain strong relationships with senior stakeholders, including Quality, Regulatory, Manufacturing, Operations, Supply Chain, IT, Engineering and C-suite decision-makers.
• Translate client quality and business challenges into clearly defined service opportunities and commercially viable solutions.
• Lead or support client meetings, discovery sessions, workshops, proposals, presentations and RFP/RFI responses.
• Develop proposals, statements of work, scopes, pricing inputs and commercial presentations.
• Work collaboratively with technical and delivery teams to develop tailored solutions.
• Identify opportunities for account expansion, cross-selling and long-term strategic partnerships.
• Maintain a strong understanding of market trends, client needs, competitive activity and emerging Life Sciences requirements.
• Contribute to revenue forecasting, pipeline development, CRM management and commercial reporting.

Client & Account Leadership

• Establish trusted-advisor relationships with key clients.
• Act as a senior point of contact for strategic quality and compliance engagements.
• Ensure that proposed solutions are aligned with client objectives, regulatory requirements and business priorities.
• Support successful delivery and client satisfaction, creating opportunities for repeat and expanded engagements.
• Represent the organisation at industry conferences, networking events, customer meetings and professional forums.

Key Skills & Experience

Essential:

• Significant senior experience within Quality, Quality Systems, Quality Assurance or Quality/Regulatory consulting in the Life Sciences sector.
• Strong practical understanding of GxP and regulated Quality Management Systems.
• Experience working with pharmaceutical, biotechnology, medical device, diagnostics, CDMO or related Life Sciences organisations.
• Demonstrable experience developing or improving QMS frameworks and quality processes.
• Strong understanding of regulatory expectations and inspection/audit environments.
• Proven experience engaging with senior client stakeholders.
• Demonstrable business development, sales, account management or commercial consulting experience.
• Ability to translate technical Quality requirements into commercially relevant business solutions.
• Excellent communication, presentation, negotiation and relationship-management skills.
• Strong commercial awareness and ability to identify and develop new opportunities.
• Ability to operate credibly with both technical Quality professionals and senior business executives.

Desirable:

• Experience across multiple Life Sciences sectors, e.g. Pharma, Biotech, Medical Devices, Diagnostics or Advanced Therapies.
• Experience in Quality transformation, QMS implementation, remediation or operational excellence.
• Experience with digital QMS platforms and/or technology-enabled Quality solutions.
• Experience leading large or complex consulting programmes.
• Existing network of contacts within the Life Sciences industry.
• Relevant professional qualification or degree in Life Sciences, Engineering, Quality, Regulatory Affairs or a related discipline.
• Formal Quality qualification such as ASQ, CQI/IRCA, or equivalent.