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:
Work authorisation:
Location:
- Dublin, County Dublin (preferred)
Work Location: In person
