Overview
Vice President – Corporate Quality Assurance Jobs in Roscommon, County Roscommon, Ireland at Collins McNicholas Recruitment & HR Services Group
Title: Vice President – Corporate Quality Assurance
Company: Collins McNicholas Recruitment & HR Services Group
Location: Roscommon, County Roscommon, Ireland
Vice President – Corporate Quality Assurance
Location: Roscommon, Ireland ( with travel to India on a mandatory quarterly basis)
Employment Type: Permanent, Executive Leadership Role
Overview
A leading global healthcare manufacturing organisation is seeking an experienced Vice President – Corporate Quality Assurance to lead a major quality transformation programme across its international manufacturing network.
This is a strategic enterprise-level role responsible for strengthening the global Quality Management System (QMS), improving regulatory readiness, reducing quality risks, and building a world-class quality culture. The successful candidate will have 5 direct reports within the Corporate QA team.
In addition, the VP – Corporate Quality Assurance will provide dotted-line oversight to Site QA Heads across our global manufacturing locations – 3 Site Leads
The position will oversee quality governance across manufacturing sites globally -Operational facility: India – 3 facilities Ireland 1 site, USA 1 site.
Key Responsibilities
Corporate Quality Leadership & QMS Transformation
- Lead and develop the Corporate Quality Assurance function across multiple global manufacturing sites.
- Establish and maintain a harmonised global Quality Management System aligned with medical device and healthcare regulatory requirements.
- Standardise quality processes, procedures, documentation, and performance metrics across sites.
- Drive continuous improvement initiatives to enhance quality maturity and compliance.
Digital Quality Transformation
- Lead the implementation and deployment of an enterprise eQMS platform across global operations.
- Manage digital quality transformation activities including system design, validation, data migration, user adoption, governance, and ongoing optimisation.
- Ensure compliance with data integrity requirements and computer system validation standards.
Regulatory Compliance & Inspection Readiness
- Own global regulatory compliance strategy and ensure ongoing inspection readiness.
- Lead regulatory inspections, customer audits, and quality assessments.
- Ensure compliance with applicable medical device and healthcare regulations including ISO 13485, EU MDR, FDA requirements, and global quality standards.
Complaint, CAPA & Risk Management
- Provide strategic oversight of product complaints, investigations, CAPA systems, deviations, and risk management processes.
- Lead reduction of recurring quality issues through robust root-cause analysis and preventative action.
- Provide governance for recalls, field safety corrective actions, and post-market surveillance activities.
Leadership & Stakeholder Management
- Provide strategic direction and mentorship to Quality teams globally.
- Partner with Manufacturing, Engineering, Regulatory Affairs, R&D, Supply Chain, and Operations leaders.
- Influence senior stakeholders and promote a proactive, customer-focused quality culture.
Candidate Profile
The ideal candidate will be an established Quality leader with significant experience within a highly regulated healthcare, medical device, pharmaceutical, or combination-product manufacturing environment.
Essential Experience:
- 15+ years’ experience in Quality Assurance leadership roles within regulated manufacturing.
- Proven experience leading corporate or multi-site quality functions.
- Strong background in medical devices, implantable devices, sterile products, or combination products.
- Experience managing global regulatory inspections and customer audits.
- Demonstrated success improving quality performance through CAPA reduction, complaint management, risk mitigation, and process improvement.
- Hands-on experience implementing digital quality systems (eQMS) such as MasterControl, TrackWise, or similar platforms.
- Strong understanding of:
- ISO 13485
- EU MDR
- FDA Quality System Regulations
- GMP requirements (where applicable)
- Post-market surveillance and device vigilance
Qualifications
- Degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, Quality, or related discipline.
- Quality certifications such as ISO 13485 Lead Auditor, ASQ CQA/CMQ, Lean Six Sigma, or equivalent are advantageous.
Key Attributes
- Strategic and transformational leadership approach.
- Ability to operate at executive level and influence business decisions.
- Strong crisis management and problem-solving capability.
- Excellent communication and stakeholder management skills.
- Ability to build high-performing teams and embed a proactive quality culture.
This is an opportunity for an experienced quality executive to play a pivotal role in transforming a global healthcare organisation’s quality function, strengthening regulatory confidence, implementing digital quality capabilities, and enabling future growth.
For further details please contact [email protected] or call Gillian on 90 6450665
