Program Manager – Compliance

  • Reference: GJ445566
  • Job Type: Permanent
  • Location: Connacht, Galway, Galway City
  • Category: Science, Pharmaceutical & Food

FURTHER, TOGETHER

Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let’s work together to address the universal healthcare needs and improve patients’ lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.

OUR PURPOSE 
At our Technical Services Department, we focus on driving synergies and best practice in infrastructure, real estate, services and construction projects to enable the Galway Parkmore Campus to deliver its business objectives. 

OUR OFFER
You will be responsible for leading the compliance and continuous improvement activities within the Technical Services function. You will provide governance and leadership to establish best practice in accordance with ISO13485, 21 CFR and Corporate Quality standards and Regulatory requirements. You will partner with Subject Matter Experts (SMEs) to establish best in class systems and procedures for maintenance of site general, electrical and mechanical equipment, cleanroom validations, equipment and software validations. You will ensure that all applicable regulatory requirements are reflected in internal documentation and implement changes when requirements are revised in accordance with documentation and industry best practice. You will establish a comprehensive system to support investigations for CAPA’s, MIR’s and Technical Services investigations to address root causes and systemic issues, cultivating and imbedding these competencies within the function. You will coach and develop team members in supporting internal and external audits of the Technical Services Function. You will lead the continuous improvement strategy and change management for the function, maintaining performance reports and KPI’s. You must be capable of leading and driving projects / sub-projects as necessary.

 

Qualifications

 

YOUR PROFILE
You are a qualified person to Degree level in Engineering / Science or related discipline, with 7-10 years’ experience working in quality, compliance, validations. Experience in problem solving techniques including DMAIC is an advantage. You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams. You are experienced in PowerPoint, Excel Word etc. Good communication, organizational, presentation and leadership skills are desirable with a high level of enthusiasm and motivation. You are a good communicator and fluent in English, both in writing and speaking. 

Leadership Expectations provide the framework for what we expect from all employees – outlining the actions and behaviors we must develop and demonstrate in pursuit of our Mission and global growth goals. 

SHAPE
We are committed to being experts in what we do, with a clear vision of where we are going and the plan to get there.
■ Demonstrates Global Business Acumen
■ Thinks Critically and Makes Sound Decisions
■ Sets Strategic Direction

ENGAGE
We partner with and involve others, knowing that diverse talent, skills, and perspectives lead to better outcomes.
■ Collaborates and Creates Alignment
■ Attracts, Deploys, and Develops Talent
■ Fosters Diversity and Inclusion

INNOVATE
We are bold thinkers who create new ideas and bring our best solutions forward to benefit our patients, partners, and customers.
■ Focuses on Patient and Customer
■ Generates Breakthrough Ideas
■ Initiates and Leads Change

ACHIEVE
We do what we say we are going to do, delivering results with the highest standards.
■ Sets High Standards
■ Instils Operational Excellence
■ Drives Accountability
■ Models Ethical Behavior


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Christopher O'Toole

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  • Christopher O'Toole
  • Senior Recruitment Consultant
  • 091 706713
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