Quality Operations, Manager

Found in: beBee S IE - 3 weeks ago

Dunboyne, Ireland MSD Full time

Job Description

An exciting opportunity has arisen for a Quality Manager in the Biologics facility, at our site in Dunboyne.

Reporting to the Associate Director of QA Operations within Global Development Quality (GDQ), the Quality Manager role will support the Quality Assurance activities in our Research & Development Division facility.
 

The Quality Manager is a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations.


The start-up facility will utilize the latest innovations in technology and automation, where you will work as part of a high performing cross-functional team. Together, we will build the future through a culture that delivers safety first, quality always to our patients.


You will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. You will have fulfilled the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment. You will be actively supported and encouraged to continue your development and knowledge build, incorporating areas to support your future development and ability to continuously improve in the current role. The candidate will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.

What You Will Do

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

  • Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
  • Lead QA oversight within the business unit for qualification/validation activities, technical transfers, regulatory approvals and Commercial/ Clinical operations at the facility.
  • Lead QA review and approval of Change Controls, Deviations/CAPAs, Risk assessments, SOPS and related documentation for compliance to GMP and site requirements at the facility within the business unit.
  • Manage Material Release process for the QA team including issue resolution ensuring materials are available to meet Operational needs and agreed timelines are achieved.
  • Manage the Quality Operations team, Training/ Coaching & Development Plan for direct reports.
  • Participate and provide QA leadership for investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
  • Manage the generation and review of all batch manufacturing records within the business unit as part of production start-up, exception closeout and batch record review activities ensuring agreed timelines are met to meet batch release timelines.
  • Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
  • Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
  • Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements.
  • Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
  • Participate in and support risk management activities in line with relevant guidance and best industry practice.
  • Assist in the execution of the internal audit programme including the performance of audits are required.
  • Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
  • Ensures the escalation of compliance risks to management in a timely manner.

Key Requirements:

  • Degree qualification (Science/Quality/Technical).
  • 8-10 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
  • Project Manager capability with significant understanding of Operations.
  • Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
  • Strong written and verbal communication skills.
  • Ability to think logically and be proactive under pressure.
  • Ability to work as part of a team and on own initiative in a constructive manner.
  • Strong attention to detail and precision in preparing and reviewing GMP documentation.
  • Experience in quality management systems such as Veeva, SAP, PAS-X etc.
  • Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
  • Experience in direct interactions with regulatory agencies during site inspections.

Desirable

  • Previous people management is desired but not essential.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

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.  

 

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.  

 

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.  

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model 

 

So, if you are ready to: 

 

Invent solutions to meet unmet healthcare needs, please apply today. 

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):


Requisition ID:R288332

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