Job Details: Senior Manager - QA Operations


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Senior Manager - QA Operations
Location: Not Specified

We are seeking applications for an experienced Senior Quality
Operations Manager for our Clients exciting biologics expansion
project. The successful candidate will be a strong No. 2 to the Site
Quality Head.

This role is a key role in developing Quality Heads (Directors) within
our Clients manufacturing network. This position requires a strong
leader who will be the Quality Director delegate as needed and partner
closely with the Senior Leadership team. With an international
manufacturing presence and a strong pipeline of products, there will
be continuous opportunities to be involved in Global Projects and to
grow your career.

Why you should apply:

* As this expansion is a start-up project, in this role you will have
the opportunity to build your very own team from scratch and then lead
and coach this diverse, technical team of expert Quality
professionals. You will be responsible for leading the complete
product lifecycle - from the technical transfer of investigational new
products and the monitoring of overall performance of these products
through to implementation of post-approval changes.

What you will be doing:

* Recruit & lead the QP & QA Operations group, including batch
release, product performance, Data Analytics, new products
introduction (NPI), and interface with HPRA and FDA.

* In this role, you will act as the primary delegate to the Quality
Director and regularly interact with the Senior Management Team.

* NPI is key to the growth of the business. As the Senior Quality
Operations Manager, you will support the effective transfer of NPIs to
site and into commercial manufacturing; coordinating with external
global teams including, but not limited to S&T, Regulatory and CMC QA.

* You will empower your team to ensure any deviations or planned
changes in production or quality control have been addressed according
to all relevant regulatory requirements and company policies and
procedures. As manager, you will mentor and coach your QPs, building
their technical expertise.

* Ensure product manufacture is in accordance with Good Manufacturing
Practice and meets requirements of our patients, Regulatory
Authorities (FDA, HPRA etc.) and of the company.

* Partner with internal and external Regulatory groups, FDA, HPRA etc.
while liaising with operations, technical operations, science &
technology teams in relation to product filing support.

* Have responsibility for the oversight of product performance
process, product quality Review, complaints and product track and
trend

* Ensure compliance with all processes and procedures while
maintaining the Quality Risk Management (QRM) program on site

* Have knowledge and experience up to date on market and product
(technical and scientific) progress and changes in regulations and
quality management related to our range of products.

What you need to apply:

* Third level qualification in a relevant science discipline with
minimum 5 years&#**Apply on the website**; experience in the
pharmaceutical industry

* MSc in Industrial Pharmaceutical Science or similar course
recognized by Regulatory Authority to permit Qualified Person (QP)
status as per Article **Apply on the website** of Directive **Apply on
the website**/**Apply on the website**/EC desirable.

* Minimum 5 years industrial experience gained in an FDA and EMA
approved pharmaceutical environment.

* Minimum 3 years&#**Apply on the website**; experience in an aseptic
sterile fill finish manufacturing environment an advantage

* People Management experience is required

We are seeking applications for an experienced Senior Quality
Operations Manager for our Clients exciting biologics expansion
project. The successful candidate will be a strong No. 2 to the Site
Quality Head.

This role is a key role in developing Quality Heads (Directors) within
our Clients manufacturing network. This position requires a strong
leader who will be the Quality Director delegate as needed and partner
closely with the Senior Leadership team. With an international
manufacturing presence and a strong pipeline of products, there will
be continuous opportunities to be involved in Global Projects and to
grow your career.

Why you should apply:

* As this expansion is a start-up project, in this role you will have
the opportunity to build your very own team from scratch and then lead
and coach this diverse, technical team of expert Quality
professionals. You will be responsible for leading the complete
product lifecycle - from the technical transfer of investigational new
products and the monitoring of overall performance of these products
through to implementation of post-approval changes.

What you will be doing:

* Recruit & lead the QP & QA Operations group, including batch
release, product performance, Data Analytics, new products
introduction (NPI), and interface with HPRA and FDA.

* In this role, you will act as the primary delegate to the Quality
Director and regularly interact with the Senior Management Team.

* NPI is key to the growth of the business. As the Senior Quality
Operations Manager, you will support the effective transfer of NPIs to
site and into commercial manufacturing; coordinating with external
global teams including, but not limited to S&T, Regulatory and CMC QA.

* You will empower your team to ensure any deviations or planned
changes in production or quality control have been addressed according
to all relevant regulatory requirements and company policies and
procedures. As manager, you will mentor and coach your QPs, building
their technical expertise.

* Ensure product manufacture is in accordance with Good Manufacturing
Practice and meets requirements of our patients, Regulatory
Authorities (FDA, HPRA etc.) and of the company.

* Partner with internal and external Regulatory groups, FDA, HPRA etc.
while liaising with operations, technical operations, science &
technology teams in relation to product filing support.

* Have responsibility for the oversight of product performance
process, product quality Review, complaints and product track and
trend

* Ensure compliance with all processes and procedures while
maintaining the Quality Risk Management (QRM) program on site

* Have knowledge and experience up to date on market and product
(technical and scientific) progress and changes in regulations and
quality management related to our range of products.

What you need to apply:

* Third level qualification in a relevant science discipline with
minimum 5 years&#**Apply on the website**; experience in the
pharmaceutical industry

* MSc in Industrial Pharmaceutical Science or similar course
recognized by Regulatory Authority to permit Qualified Person (QP)
status as per Article **Apply on the website** of Directive **Apply on
the website**/**Apply on the website**/EC desirable.

* Minimum 5 years industrial experience gained in an FDA and EMA
approved pharmaceutical environment.

* Minimum 3 years&#**Apply on the website**; experience in an aseptic
sterile fill finish manufacturing environment an advantage

* People Management experience is required Location: Not Specified

We are seeking applications for an experienced Senior Quality
Operations Manager for our Clients exciting biologics expansion
project. The successful candidate will be a strong No. 2 to the Site
Quality Head.

This role is a key role in developing Quality Heads (Directors) within
our Clients manufacturing network. This position requires a strong
leader who will be the Quality Director delegate as needed and partner
closely with the Senior Leadership team. With an international
manufacturing presence and a strong pipeline of products, there will
be continuous opportunities to be involved in Global Projects and to
grow your career.

Why you should apply:

* As this expansion is a start-up project, in this role you will have
the opportunity to build your very own team from scratch and then lead
and coach this diverse, technical team of expert Quality
professionals. You will be responsible for leading the complete
product lifecycle - from the technical transfer of investigational new
products and the monitoring of overall performance of these products
through to implementation of post-approval changes.

What you will be doing:

* Recruit & lead the QP & QA Operations group, including batch
release, product performance, Data Analytics, new products
introduction (NPI), and interface with HPRA and FDA.

* In this role, you will act as the primary delegate to the Quality
Director and regularly interact with the Senior Management Team.

* NPI is key to the growth of the business. As the Senior Quality
Operations Manager, you will support the effective transfer of NPIs to
site and into commercial manufacturing; coordinating with external
global teams including, but not limited to S&T, Regulatory and CMC QA.

* You will empower your team to ensure any deviations or planned
changes in production or quality control have been addressed according
to all relevant regulatory requirements and company policies and
procedures. As manager, you will mentor and coach your QPs, building
their technical expertise.

* Ensure product manufacture is in accordance with Good Manufacturing
Practice and meets requirements of our patients, Regulatory
Authorities (FDA, HPRA etc.) and of the company.

* Partner with internal and external Regulatory groups, FDA, HPRA etc.
while liaising with operations, technical operations, science &
technology teams in relation to product filing support.

* Have responsibility for the oversight of product performance
process, product quality Review, complaints and product track and
trend

* Ensure compliance with all processes and procedures while
maintaining the Quality Risk Management (QRM) program on site

* Have knowledge and experience up to date on market and product
(technical and scientific) progress and changes in regulations and
quality management related to our range of products.

What you need to apply:

* Third level qualification in a relevant science discipline with
minimum 5 years&#**Apply on the website**; experience in the
pharmaceutical industry

* MSc in Industrial Pharmaceutical Science or similar course
recognized by Regulatory Authority to permit Qualified Person (QP)
status as per Article **Apply on the website** of Directive **Apply on
the website**/**Apply on the website**/EC desirable.

* Minimum 5 years industrial experience gained in an FDA and EMA
approved pharmaceutical environment.

* Minimum 3 years&#**Apply on the website**; experience in an aseptic
sterile fill finish manufacturing environment an advantage

* People Management experience is required

We are seeking applications for an experienced Senior Quality
Operations Manager for our Clients exciting biologics expansion
project. The successful candidate will be a strong No. 2 to the Site
Quality Head.

This role is a key role in developing Quality Heads (Directors) within
our Clients manufacturing network. This position requires a strong
leader who will be the Quality Director delegate as needed and partner
closely with the Senior Leadership team. With an international
manufacturing presence and a strong pipeline of products, there will
be continuous opportunities to be involved in Global Projects and to
grow your career.

Why you should apply:

* As this expansion is a start-up project, in this role you will have
the opportunity to build your very own team from scratch and then lead
and coach this diverse, technical team of expert Quality
professionals. You will be responsible for leading the complete
product lifecycle - from the technical transfer of investigational new
products and the monitoring of overall performance of these products
through to implementation of post-approval changes.

What you will be doing:

* Recruit & lead the QP & QA Operations group, including batch
release, product performance, Data Analytics, new products
introduction (NPI), and interface with HPRA and FDA.

* In this role, you will act as the primary delegate to the Quality
Director and regularly interact with the Senior Management Team.

* NPI is key to the growth of the business. As the Senior Quality
Operations Manager, you will support the effective transfer of NPIs to
site and into commercial manufacturing; coordinating with external
global teams including, but not limited to S&T, Regulatory and CMC QA.

* You will empower your team to ensure any deviations or planned
changes in production or quality control have been addressed according
to all relevant regulatory requirements and company policies and
procedures. As manager, you will mentor and coach your QPs, building
their technical expertise.

* Ensure product manufacture is in accordance with Good Manufacturing
Practice and meets requirements of our patients, Regulatory
Authorities (FDA, HPRA etc.) and of the company.

* Partner with internal and external Regulatory groups, FDA, HPRA etc.
while liaising with operations, technical operations, science &
technology teams in relation to product filing support.

* Have responsibility for the oversight of product performance
process, product quality Review, complaints and product track and
trend

* Ensure compliance with all processes and procedures while
maintaining the Quality Risk Management (QRM) program on site

* Have knowledge and experience up to date on market and product
(technical and scientific) progress and changes in regulations and
quality management related to our range of products.

What you need to apply:

* Third level qualification in a relevant science discipline with
minimum 5 years&#**Apply on the website**; experience in the
pharmaceutical industry

* MSc in Industrial Pharmaceutical Science or similar course
recognized by Regulatory Authority to permit Qualified Person (QP)
status as per Article **Apply on the website** of Directive **Apply on
the website**/**Apply on the website**/EC desirable.

* Minimum 5 years industrial experience gained in an FDA and EMA
approved pharmaceutical environment.

* Minimum 3 years&#**Apply on the website**; experience in an aseptic
sterile fill finish manufacturing environment an advantage

* People Management experience is required

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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