GE HealthCare Quality Operations Leader 

Ireland, Cork 

344074634

ORGANISATION POSITIONING:

You report to:QO Director

While you don’t report indirectly, you play a critical co-ordination role for the many other departments and functions that support the Quality Department.

QUALIFICATIONS/SKILLS AND WORK EXPERIENCE REQUIRED:

• You possess the curiosity of a life-long learner.
• You have achieved at least a Professional Level 8 degree qualification and you have (or aspire to) a Level 9 (Master's degree). You may still be in the process of achieving your qualifications.
• QP Qualification is desirable
• You have achieved or aspire to achieve a recognized Coaching qualification and use the tools, skills and techniques as your default style of leading / managing
• You have proven Quality operations experience of managing teams in a fast-paced and complex environment using LEAN mindset, principles and resources, preferably in a pharmaceutical environment
• You have demonstrated strong people management experience in a Quality Leadership role
• You are a confident decision maker, an effective planner, and an effective communicator with strong leadership skills
• You are likely to have some experience in working, developing strong working relationships and influencing cross-functionally
• Clear thinker who can analyze data to establish a direction to proceed
  

MAIN DUTIES & RESPONSIBILITIES:

• Key member of the Quality Leadership Team contributing to the overall success and direction of the Cork site.

• Leading and driving specific product compliance across site
• Accountable for delivering Quality Metrics
• Translates the Quality vision into goals, objectives strategies and measures for the site.
• Creates transparency, visibility and monitoring of common quality metrics in the QA organisation.
• Responsible for the leadership of employees as well as coaching and development QA professionals
• Assure site and business is properly prepared for external and internal compliance inspections by having results from their inspections be non-systemic and without warning letters. Collaborate closely with business partners to ensure site is audit ready at all times
• Understanding customer needs, marketplace dynamics, industry trends & the competitive landscape in the industry & considers the external impact of business activities & decisions on the external environment.
• Assure specific site and business goals are established and met for compliance, training, CAPA, complaints and production process controls
• Accountable for ensuring full quality and regulatory compliance of the facility, while driving process effectiveness and efficiency at the site.
• Deputize for Quality Director as required
• Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums.
• Responsible for site education of non-Quality Assurance employees along with professional development of the site Quality Assurance team.
• Provide leadership and coaching for the Quality Control team & ensure the timeliness of testing of our products manufactured- Support & participate in the site-wide efforts to reduce scrap and rework costs, and to identify root causes and solutions for quality defects.
• Work with Manufacturing, Engineering, Design, Validation and NPI teams to drive changes that will reduce quality issues and result in higher long-term reliability.
• Utilize data driven insights to identify trends, root caused and areas for improvement

• Have External Focus to understand business and Quality trends in the global supply chain and implement best practices in Cork site.

• Identify skills and competency gaps, providing leadership and direction within own functional remit. Ensure personal development plans and talent matrix succession pipelines are in place and regularly reviewed and that a culture of continuous learning is promoted and maintained.
• Ensure all work completed by team adheres to EHS policies
• Ensure compliance with current technical, Quality and regulatory standards and guidelines
• Promote Servant Leadership practice

• Leading, motivating, developing, and managing the performance of the Quality Operations team

• Have an ability to lead technical root cause investigations.
• Ensuring company administrative procedures and policies are implemented in the department
• Responsible for developing people, training, and technical skills to maximise operational equipment uptime, implement new technologies and applying best practice in maintenance methods and systems.

• Ensuring Systems, Policies and Procedures are in place and up to date to ensure maintenance activities are carried out in compliance with Environmental, Safety, Health, Good Engineering Practice, continued Good Manufacturing Practice, and other corporate standards and regulations.
• Responsibility for authorisation and maintenance of process validation documentation and ensuring these meet regulatory requirements
• Ensuring a process validation master plan is kept current and implemented
• Ensuring Validation activities are carried out in compliance with product license commitments, cGMP and company Quality standards, responsible for Process validation assessment and approval of compliance documentation

Total Rewards

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