Quality & Data Integrity Risk Management Lead

Job Description A fantastic opportunity has arisen for a Quality & Data Integrity Risk Management Lead at our Biologics commercialisation facility at Dunboyne, Co. Meath. This role will be responsible for driving the Quality & Data Integrity Risk Management Program for areas within the remit of the Quality organisation at Dunboyne Biologics. Bring energy, knowledge, innovation to carry out the following

1. Integrate a harmonized global risk management program into Site Quality Management System.
2. Responsible for integration of Quality Risk Management as it relates to data governance and GMP records.
3. Be the primary contact between the Global Quality Risk Management Organization and our facilities.
4. Co-ordinate execution of risk assessments, risk control, risk communication and risk review.
5. Ensure site risk register and inventory is maintained and communicated.
6. Provide risk management & data integrity training on site as required.
7. Provide periodic updates to Quality Council on site risk status & relevant metrics as required.
8. Lead the Site Quality Risk Management Council governance process.
9. Ensure Site DI governance process is in place.
10. Represent organisation at Industry forums.
11. Implementation of ongoing DI GEMBA program within site.
12. Support investigations from a QRM and DI perspective as required.
13. Support Inspection Readiness, Hosting & Response activities as required.

Preferred Qualification and Experience

1. Minimum degree or post-graduate qualification (Science/ Pharmacy/ Engineering).
2. 10 years’ working knowledge of Quality Assurance and Quality Risk Management Principles.
3. Understanding and practical application of GMP standards and regulations.
4. Strong working knowledge of laboratory, manufacturing and supporting computerised systems, and associated business processes.
5. Working knowledge of Quality Risk Management regulations and best practices.
6. Seasoned in governance processes and management.
7. Proven record of influencing change.
8. Skilled supporting cross-functional investigations.
9. Analytical problem-solving skills.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. So, if you are ready to: Invent solutions to meet unmet healthcare needs, impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/24/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R331247#J-18808-Ljbffr