Job Title: Senior Quality Assurance/Data Integrity Job Function: Deviations & CAPA: Orchestrating Excellence Job Type: Full Time Contract Location: Limerick,Ireland About RCM: RCM Life Sciences & IT is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America Scope of Job: RCM is seeking a Quality Assurance/Data Integrity Lead to help support our client's expanding Quality Assurance Vertical. If you are an experienced QA leader who thrives in a challenging environment, possesses a deep understanding of deviation and CAPA processes, and can navigate the complexities of data integrity, we encourage you to apply! This is an opportunity to make a significant impact on our organization's quality and compliance and shape the future of our QA function. Primary Responsibilities:

　　Deviations & CAPA Mastery: Leverage your 10+ years of experience handling deviations and corrective action/preventive action (CAPA) processes to lead investigations, identify root causes, implement effective remediations, and ensure long-term corrective actions prevents recurrence.

　　Championing Data Integrity: Advocate for and uphold the highest standards of data integrity across the organization, analyze trends, evaluate potential data risks, and collaborate with stakeholders to develop and implement robust data integrity strategies.

　　Leadership & Collaboration: Lead a team of QA professionals, fostering a collaborative and growth-oriented environment. Mentor and coach team members, delegate tasks effectively, and ensure efficient execution of quality initiatives.

　　Strategic Vision & Communication: Partner with cross-functional teams to strategize on large scale QA initiatives. Translate complex technical data into actionable insights for leadership and stakeholders, facilitating impactful decision-making through clear and concise communication.

　　Process Optimization: Continuously assess and optimize internal QA processes, implementing best practices and innovative solutions to drive efficiency and improve quality at every stage.

　　Regulatory Compliance: Ensure adherence to all relevant regulatory requirements and industry standards relevant to the organization's operations.

　　Qualifications:

　　Minimum 10 years of experience in quality assurance, with a strong focus on deviations and CAPA management.

　　Must have recent experience within the Life Sciences/Healthcare industry.

　　Proven track record of successfully leading and resolving complex deviation and CAPA cases.

　　In-depth understanding of data integrity principles and best practices.

　　Strong analytical and problem-solving skills, with the ability to identify root causes and implement effective solutions.

　　Excellent communication, collaboration, and leadership skills.

　　Experience working in a fast-paced, dynamic environment.

　　Experience in implementing quality management systems (e.g., ISO 13485, FDA QSR)

　　Knowledge of specific industry regulations relevant to the organization.

　　Experience with statistical analysis and data visualization tools.

　　Bachelor's degree in a relevant field (e.g., science, engineering, healthcare) preferred.

　　Education & Certification Bachelor's Degree (BS/BA) from an accredited college or university Equal Opportunity Statement RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Disclaimer This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs, as necessary.