דרושים Quality Systems Leader ב-Ge Healthcare ב-Ireland, Cork

• Lead and maintain core quality systems including CAPA, Change Control, Document Management, Training, Audit Management, and Risk Management.

• Oversee the complaints handling process, ensuring timely investigation, root cause analysis, and implementation of effective corrective and preventive actions.

• Lead the preparation and execution of periodic QMRs, ensuring comprehensive analysis of quality system performance.

• Manage the APR process to ensure timely and accurate review of product quality data and implementation of improvements.

• Ensure the QMS meets all relevant regulatory requirements and support audits and inspections.

• Identify and implement improvements to quality systems to enhance efficiency and compliance.

• Lead and develop a team of quality professionals, fostering a culture of accountability and learning.

• Develop and report on key quality metrics and communicate performance to senior leadership.

• Oversee the quality training program to ensure employees are trained and competent.

• Lead risk assessments and mitigation strategies related to quality systems and compliance.

• Bachelor’s degree in a scientific, engineering, or related discipline (Master’s preferred) or equivalent.

• Strong experience in Quality Assurance or Quality Systems in a regulated industry.

• Solid experience in people leadership, including team development and coaching.

• Strong knowledge of global regulatory requirements and standards

• Proven leadership experience with cross-functional teams.

• Excellent communication, analytical, and problem-solving skills.

• Experience with electronic QMS platforms (e.g., Veeva, TrackWise, MasterControl)

• Lean Six Sigma or similar continuous improvement certification.

• Experience in leading regulatory inspections.

• Ability to influence and drive change in a matrixed organization.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Implement, and maintain IT systems and software for the Quality department to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH).

• Manage the investigation and resolution of IT-related issues, including system non-conformances and deviations. Lead investigation and troubleshooting on critical Lab application issues, and coordinate with different teams to get desired results.

• Adept at requirements gathering & analysis through leading business process review sessions and stakeholder interviews.

• Translate unstructured or ambiguous requests into actionable requirements through problem decomposition and planning.

• Ability to map As-Is process based on inputs from business SME’s and help establish the future process state

• Prioritize continuously in accordance with the understanding and validation of customer problems and needs.

• Stay updated with industry trends and regulatory changes to ensure compliance and best practices.

• Lead the implementation of new IT technologies and methodologies to enhance QC efficiency and accuracy.

• Own the short-term product roadmap and its integration into a larger application or strategic roadmap.

• Strong written and verbal communication skills.

• Function as communication hub for business to collate requirements and coordinate & drive deliverables.

• Demonstrates strong analytical and creative problem solving and prioritisation skills

• Demonstrate practical experience in Business Analysis methodologies to run meetings & stand-ups, relevant project documentation, and change controls to collaborate with all stakeholders.

• A Bachelor's Degree in Computer Science or “STEM” Majors (Science, Technology, Engineering and Math) or equivalent

• Strong relevant professional experience in working in the Pharma or IT Industry including experience in the Digital Lab domain

• Technical experience with Quality platforms such as, but not limited to – LIMS (Lab Information Management System), Chromatography systems (Chromeleon, Empower) , Environmental Monitoring, Quality Management systems is Mandatory.

• Expert understanding of analysis & design and system architecture concepts.

• Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP), 21CFR Part 11, EU Annex 11.

• Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues.

• Expert understanding of the Lab business processes, drug development experience an advantage

• Ability to break down problems, build requirements for development tasks in an agile manner.

• Experience with Cloud technologies, Java, JavaScript, JBoss, SQL, Windows Server, Citrix, Integrations

• Experience working in remote / global teams.

• Entrepreneurial mindset - champions new technology, predicts trends, and identifies new opportunities based on trends. Ability to make technology choices based on experience and willingness to take calculated risks and experiment with newer technologies.

• Ability to develop partnership with stakeholders and develop an inclusive & collaborative environment.

• Ability to effectively present portfolio, project plans, technical roadmaps, risks and recommendations to senior business leaders

• Certifications such as CSBA, CBAP, or PMP

• Pre-emptively sees downstream consequences and effectively tailors influencing strategy to support a positive outcome.

• Able to verbalize what is behind decisions and downstream implications. Continuously reflecting on success and failures to improve performance and decision-making.

• Understands when change is needed. Participates in technical strategy planning.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Managing and developing the QC analyst team to provide safe, compliant, timely and cost effective QC support to the plant

• Ensuring product testing is scheduled and completed in a timely manner in compliance with cGxP.

• Provide technical support to the Analyst team for the investigation and closure of investigations

• Responsible for leading and delivering QC projects

• Defining Quality Control Policies, in consultation with QA guidelines

• To take the responsibility for delivering the departments functional goals including people development.

• Ensuring systems are in place to assure QC activities are carried out in compliance with product licence commitments, cGMP and Quality standards

• Fostering an environment of continuous improvement and providing leadership in this area by identifying and implementing LEAN practices to deliver efficiency, cost reduction, quality and service level improvements.

• Leading local and cross functional investigations

• Responsible for managing a programme to develop people and technical skills to implement new technologies and apply best practice in QC techniques and systems.

• Primary degree in Science essential supported by a sound technical background in a chemistry discipline or equivalent

• Strong supervisory experience in Pharmaceutical industry desirable

• Excellent leadership and communication skills are a pre-requisite for this role.

• Highly attentive to detail

• Good organizational and communication skills

• Willingness to learn

• Ability to work as part of a team but also self-motivated

• Ability to work under pressure

• Strong problem-solving skills and a proactive attitude towards identifying and addressing quality issues.

• Ability to work independently and collaboratively in a fast-paced, dynamic environment, managing multiple priorities and deadlines effectively.

• Strong analytical skills and attention to detail, with the ability to identify, troubleshoot, and resolve issues.

• Excellent communication skills, with the ability to convey technical information effectively to both technical and non-technical stakeholders.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.