Job Description

In this role will be part of our QA Operations Self Directed Work Team (SDWT) in our state-of-the-art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. 

As the Senior QA Operations Specialist you will be responsible for supporting and providing compliance expertise in relation to New Product Introduction (NPI), including but not limited to, Process Validation, Analytical Technical Transfer (ATT) and New Material Introduction (NMI). In conjunction with this NPI focus, you will also support the routine activities of the QA Operations team including Deviation Management, Documentation review and approval, Change Controls and Quality risk management.

You will work across the site self-directed work teams and hub teams to identify and resolve issues to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement. 

Bring energy, knowledge, innovation and leadership to carry out the following:

Review and approve documentation, including batch records, operational procedures, discrepancy reports, deviations, CAPAs, change controls, quality risk assessments, and continuous improvement projects related to all areas of manufacturing operations.Coordinate with internal quality groups to ensure the timely disposition of commercial drug substance materials.Liaise with internal partners (e.g., Manufacturing Operations, MS&T, Engineering, Quality Control, Supply Chain) to support daily operations.Support the execution of an effective quality system and oversee quality management systems (CAPAs, change controls, deviations, batch documentation review).Ensure clear communication on issues and timely escalation when necessary.Support the development and coaching of key members of the Quality Assurance Operations team to foster a high-performance organizational culture that accommodates rapid growth and dynamic expectations. Build the capability of the QA Operations shift team to meet the delivery and compliance oversight requirements of manufacturing operations.Drive opportunities for continuous improvement.Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, and interactions with health authority inspectors, including responses to inspection observations and follow-up actions.Champion site metrics to ensure targets are achieved and countermeasures are in place when necessary.Represent Quality on multidisciplinary teams.Ensure new or revised quality system requirements are implemented at the site.

What skills you will need:

In order to excel in this role, you will more than likely have:

Degree or post-graduate qualification in Science, Pharmacy or equivalent.At least 6 years experience in the biotechnology and/or pharmaceutical industry, (preferably both) within a Quality Operations role.Knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.Expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; and product quality improvement using tools such as six sigma, DFR, etc.Understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).Experience in performing internal audits and participating in external audits.Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.Strong operations support background ensuring value added and effective quality.Collaboration, negotiation & conflict resolution skills.Ability to work independently as well the ability to work across a team matrix are essential to meet accelerated timelines.Exceptional analytical, problem solving & root-cause analysis skills.

About Us:

The Company’s existing portfolio and future pipeline offers team members the opportunity to operate at the cutting-edge of science and technology and develop new treatments that positively impact patients across the globe.

As a company, we are committed to ‘Inventing for Life’ in all that we do. 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

01/29/2025

*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:R319411