Find Release manager Jobs in Dublin, D

Quality Manager / Responsible Person (RP) - Full time
Althera —Dublin, County Dublin
- Full-time
- Doctoral degree
- English
- Bachelor's degree
- Sick pay
Quick apply
4d
Technical Product Manager - (Clinical Integrations) - Ireland
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- Full-time
- Analysis skills
- No degree
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Quick apply
5d
Senior Project Manager
The Irish Times —Dublin, County Dublin
- Full-time
- Hybrid work
- Project management
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- Communication skills
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Quick apply
QC Manager Micro
Amgen —Dún Laoghaire, County Dublin
- €69,614.15–€94,183.85 a year
- Analysis skills
- Supervising experience
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4d
Principal Technical Program Manager
Adswizz —Dublin, County Dublin
- Full-time
- Computer Science
- Bachelor's degree
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Product Manager
Kitman Labs —Dublin, County Dublin
- Full-time
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- AI
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13d
Manager Quality Control
Amgen —Dún Laoghaire, County Dublin
- Analysis skills
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Salesforce Administrator
Trulioo —Dublin, County Dublin
- Full-time
- Hybrid work
- Sales
- Salesforce
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Senior QA Tester
Solance —Dublin, County Dublin
- Full-time
- Hybrid work
- Agile
- AI
- Communication skills
Quick apply
Claims Transformation Manager - 12 Month Contract
Allianz —Dublin, County Dublin
- Full-time
- Hybrid work
- Business development
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Delivery Program Manager
Sitecore —Dublin, County Dublin
- Full-time
- Continuous improvement
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Product Manager - Percona Monitoring and Management (Remote)
Percona —Dublin, County Dublin
- Full-time
- Remote
- English
- Linux
- AI
- Annual leave
6d
Credit & Collections Coordinator
Trane Technologies —Swords, County Dublin
- Full-time
- Microsoft Excel
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Manager, People Technology Platform Engineering (Workday)
PlayStation Global —Dublin, County Dublin
- €89,300–€133,900 a year
- Engineering
- Human resources
- Organisational skills
Quick apply
Senior QA Automation Engineer, Charles River Development
State Street —Dublin, County Dublin
- Full-time
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Registry Assistant
IBAT College Dublin —Dublin, County Dublin
- €35,000–€40,000 a year
- Full-time
- Hybrid work
- Customer service
- English
- Microsoft Office
- Annual leave
- Flexitime
Quick apply
5d
QA Lead
Elwood Roberts —Dublin, County Dublin
- Full-time
- Master's degree
- Agile
- AI
Quick apply
Product Marketing Manager
beqom —Dublin, County Dublin
- Full-time
- Remote
- Marketing
- Project management
- Bachelor's degree
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Staff Technical Program Manager
PlayStation Global —Dublin, County Dublin
- Project management
- Continuous improvement
- Software development
Quick apply
2d

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Quality Manager / Responsible Person (RP) - Full time

Althera
Dublin, County Dublin

Quick apply

Job details

Permanent | Full-time
4 days ago

Benefits

Bike to work scheme
Company pension
Sick pay
On-site parking

Qualifications

Biology
Doctoral degree
English
Quality management
C
Bachelor's degree
Chemistry

Full job description

Requirements for Quality Manager/RP

This note describes the role and requirements for Quality Manager and is organized in followings sections A. Summary description, B. About Althera, C. Job description, D. Experience and skills requirement. This Job is based in the Dublin site of Althera.

A. Summary Description

Title: Quality Manager/RP

Location: Dublin, Ireland.

Working hours: Full time

Salary: Dependent on experience/Negotiable

Experience expected: 10 to 14 years exclusively in EU GMP compliance

Education required: Graduate degree preferred

B. About Althera Pharmaceuticals

Althera is a Pharmaceutical R&D and commercialization organization with operations in US, Europe and India. The company is headquartered in Ireland. Our mission is to make significant positive impact on lives of patients by bringing to market innovative and complex products through our own development and in partnerships with other innovators. Most employees of the company are scientists with post-graduate or Ph.D. degrees. For more information, please visit us at www.altherapharma.com

Althera offers competitive salary, excellent benefits and an environment conducive to professional development.

C. Job description

The Quality Manager’s key role is to ensure Althera’s products imported and distributed in Europe are manufactured and distributed according to EU regulations. This function maintains quality compliance with Good Distribution Practices (GDP), Good Manufacturing Practices (GMP) and Althera Standard Operating Procedures (SOPs). The quality function also ensures the timely release of incoming product batches into the marketplace for sale, assisting Althera subsidiaries in meeting financial sales targets and ensuring that quality product is available to patients.

The expectations of this role are as follows:

1. Team interactions: Interaction with other members of Althera related to quality, regulatory requirements, batch importation, audits, submissions, strategic decisions and other internal conversations such as:

a. Supporting and maintaining quality and regulatory requirements in EU

b. Reviewing change controls

c. Coordinate and communicate critical input and critical timelines and deliverables to company leadership, development function and other key departments to facilitate batch release, distribution, regulatory submissions, PSUR and post approval variations, etc.

d. Communication of latest quality requirements to various teams

e. Discussions with and guidance to company leadership and product development functions specific to pipeline products/projects as requested

f. Coordination with quality assurance and regulatory affairs teams of Althera’s partners as may be required from time-to-time

g. Coordination with and management of quality assurance consultants as may be hired by the Company

h. Other interactions within company and with vendors for furtherance of company’s interests and strategy

2. Quality Assurance functional responsibilities:

a. Coordinating launch and post-launch shipments

b. Coordinating with the QPs for the timely release of batches

c. Development, periodic review, revision and implementation of SOPs as required in line with EU guidelines

d. Coordination with regulatory agencies and customers for gaining and maintaining relevant authorizations, including hosting inspections and responding to observations

e. Conduct monthly meetings with customers to track the pending activities and timely resolutions

f. Review of change controls, deviations and CAPAs

g. Participate in, and lead, relevant Quality Risk Management Assessments.

h. Monitoring stock transfers and maintaining retained samples according to GMP

i. Review of Annual product reviews and lead Quality Management Review

j. Review of stability reports for compliance with EU registrations

k. Schedule and carry out Internal Audits

l. Implement/review quality agreements with manufacturers, wholesalers and distributors

m. Ensure that bona fides are established for all customers and suppliers of medicinal products

n. Conducting inspections of manufacturers distributors and wholesalers as necessary per GMP/GDP requirements

o. Acting as primary EU quality contact person with Althera partners and also with Althera subsidiaries for internal quality compliance matters

p. Implementing recall procedures if necessary

q. Receive and conduct as required GDP/GMP training for relevant staff

r. Ensure that training plans are implemented and training records are maintained.

s. When required, to fulfil the Company’s requirements with respect to Responsible Person responsibilities for GDP.

a. Support Pharmacovigilance and Regulatory Affairs as directed when required, e.g. compliance activities, co-ordinating documentation requests

D. Experience and skills requirements

Education: Bachelor’s degree required in a scientific disciple such as Chemistry, Biology, Pharmacy or other health related field. Graduate degree preferred.

Knowledge/Skills/Qualifications:

a. Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of quality assurance and regulatory affairs departments.

b. Hands on experience in interacting on EU quality issues.

c. Ability to work cross functionally within the Company and practically apply GMP / GDP and associated legislation

d. Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.

e. Experience of conducting audits

f. Ability to assess quality risks, and where appropriate, recommend contingency plans and strategies to mitigate risks.

g. Detail oriented and highly organized.

h. Previous status of Responsible Person in accordance with the HPRA’s educational requirements, experience, training and licensing (compliance with the requirements of Directive 2013/C 343/01) is desired.

Job Types: Full-time, Contract, Permanent

Benefits:

Bike to work scheme
Company pension
On-site parking
Sick pay

Ability to commute/relocate:

Dublin, County Dublin: reliably commute or plan to relocate before starting work (required)

Application question(s):

List three reasons why you would be a suitable candidate for this role?

Experience:

Quality management: 10 years (required)
GMP: 10 years (required)

Language:

English (required)

Work authorisation:

Ireland (required)

Location:

Dublin, County Dublin (preferred)

Work Location: In person

Quick apply

Refine Your Search

release manager jobs in dublin, d

Quality Manager / Responsible Person (RP) - Full time

Technical Product Manager - (Clinical Integrations) - Ireland

Manager - Strategic IT PMO

Senior Project Manager

QC Manager Micro

Principal Technical Program Manager

Product Manager

Manager Quality Control

Salesforce Administrator

Senior QA Tester

Claims Transformation Manager - 12 Month Contract

Delivery Program Manager

Product Manager - Percona Monitoring and Management (Remote)

Credit & Collections Coordinator

Manager, People Technology Platform Engineering (Workday)

Senior QA Automation Engineer, Charles River Development

Registry Assistant

QA Lead

Product Marketing Manager

Staff Technical Program Manager

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