Quality Program Manager
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| Job Type | Fixed Term |
| Area | Sligo, Ireland |
| Sector | QualityManagement |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 1002693 |
| Job Views | 188 |
- Description
- Team Horizon is seeking a Quality Program Manager for our client based in Sligo.This is a 12- month fixed-term contract. The Quality Program Manager is responsible for ensuring new products transferred to Sligo are manufactured in accordance with applicable regulatory requirements and procedures and policies. To ensure effective and compliant transfer of New Products to the site. The Quality Program Manager will take ownership of the Risk Management Process, ensuring all related processes and procedures meet the requirements of applicable Quality and EHS standards. This person will be responsible for the management of Data Governance process on site ensuring Data Integrity.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Responsible for implementing and maintaining the effectiveness of the integration of new products into the quality system.
Ensuring the new products manufactured at Ireland NLB.V. meet requirements of applicable regulatory requirements and procedures and policies.
Site Quality Lead responsible for all new product transfers to the site from development through to commercialization, liaising closely with local and external cross functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.
Manage Quality technology transfers and set up/revises internal processes and procedures.
Collaborate with CMC QA, R&D, S&T, and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understating of the quality compliance, and resource needs of the site and provide input on quality concerns.
Coordination of site review of new product related material specification documents including but not limited to, intermediate specifications, API specifications, Drug Product specifications, raw material specifications, and excipient specifications.
Support review and approval of new product related analytical Test Method Transfers and/or validation.
Support the management of new product related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.
Generation of product transfer documentation to attest the completion of product transfer deliverables, in advance of the applicable product transfer stage gate review.
Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
Perform end-end risk assessment of all systems on site, identifying and quantifying risks and supporting the mitigation of same.
Work cross-functionally to facilitate the identification, characterization, rating and reporting of site level risk.
Monitor the outstanding CAPA’s from identified risks to ensure 100% adherence of all site commitments for EHS and Quality.
Develop and deploy robust processes and procedures for effective assessment and evaluation, of design, system, and business risk.
Support risk assessment of systems and activities that are being carried out in the business to ensure that quality and EHS Risks are managed.
Conduct reviews of all functional areas of the site to ensure that effective risk management is taking place.
Ensure that all related SOPs are in place, in use, effective, updated & training has been conducted in accordance with relevant policies.
Act as Designee for Quality Director as required.
Adheres to and supports all EHS& E Standards, procedures, and policies.
What you need to apply:
A bachelor’s degree in a relevant discipline required.
A minimum of 5 years’ experience in a Quality role.
Excellent knowledge of regulatory requirements is essential.
Leadership experience desirable but not essential.
