Job Details: Technical Director of Quality, Development Projects, Quality Operations


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Technical Director of Quality, Development Projects, Quality Operations
Overview:

Jazz Pharmaceuticals is an international biopharmaceutical company
focused on improving patients lives by identifying, developing and
commercializing meaningful products that address unmet medical needs.
We are continuing to expand our commercial product portfolio and our
research and development pipeline in therapeutic areas that can
leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology
areas in which we have a deep understanding of the patient journey and
a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If
youre looking to be a part of a company with an unwavering commitment
to improving patients lives and being a great place to work, we hope
youll explore our career openings and get to know Jazz
Pharmaceuticals.

Responsibilities:

The role of the Technical Director is to provide technical leadership
to the Quality Operations Development Projects Team to support the
Jazz development pipeline from a scientific, quality and
patient-centered viewpoint. It also includes management of development
projects within the team. The position reports to the Director of
Quality, Development Projects, Quality Operations.

RESPONSIBILITIES:

The position is responsible for the management of the day-to-day
quality activities relating to development projects and providing
technical support in relation to issues that can arise with Jazz
development products, contract manufacturing organizations and
material suppliers, to all applicable GXP standards. This role also
includes cross-functional team membership/collaboration and support
for quality aspects of CMC regulatory dossiers.

Responsible for, but not limited to:

* Provide advice on technical issues that may arise for both small
and large molecule projects including initiating/directing appropriate
risk management
* Act as a Qualified Person (QP) named on Jazz Pharmaceuticals
Manufacturing and Import Authorization (MIA) for Investigational
Medicinal Products to ensure clinical trial supply
* Provide SME technical support for the successful outcome of all
regulatory inspections, both internally and at contract manufacturers,
packagers and laboratories, as required
* Liaise with the relevant departments within the business and work
closely with the Quality Operations Development Projects Team to
ensure agreed milestones/targets are met
* Act as a quality representative on CMC Product teams for assigned
development projects
* Ensure and provide support to the Quality representatives on the
CMC Product Team(s)
* Ensure compliance of all respective contract manufacturers to both
internal Jazz requirements and country specific regulations
* Work closely with the Clinical Trial Management Supply Team to
ensure supply of clinical trial material to clinical development
programs
* Prepare and/or act as an SME for Quality Technical Agreements
within the Quality Department, as required
* Facilitate technology transfer, process scale-up and process
improvement projects i.e. assist with the transitioning of Jazz
development products from the Investigational Medicinal Product space
to Commercial Medicinal Product space
* Provide information to the Supplier Review Board in the context of
development projects
* Conduct vendor audits and vendor site visits, as required
* Review new critical regulations and guidelines, as they apply to
product development from a quality perspective, and advise and assist
with their implementation in Jazz
* Responsible for the successful, timely completion of goals and
objectives which will strengthen Jazz Quality Operations, Development
Projects team
* Provide periodic QP support within Quality Operations to support
commercial manufacture

OTHER RESPONSIBILITIES:

* Communicate, where appropriate, with all corporate personnel and
contribute to development projects, as required
* Contribute to the design and implementation of best practice
quality improvement programs and company expansion programs
* Contribute to the development of quality policies and procedures
as they relate to development products in order to ensure best
practice and compliance
* Contribute to the development of new drug products, which will
deliver a robust product pipeline without significant delays in the
regulatory approval process
* Work closely with other members of the Technical Operations group
to ensure delivery of key project objectives and timelines
* Foster a positive employee relations environment and a culture of
continuous improvement and teamwork through the use of good and
consistent management principles
* This position will require up to **Apply on the website**% travel
* Act as a Development Projects Quality representative at external
meetings

PROFESSIONAL COMPETENCIES:

* Bachelors degree in chemistry, biology, pharmacy or a related
science discipline
* Eligibility to act as a licensed Qualified Person
* **Apply on the website**+ years of practical experience in the
Pharmaceutical Industry in QA or QC role(s) with a thorough
understanding of GMP and Quality Systems as they relate to product
development
* Ideally have significant experience (**Apply on the website**
years) in drug development (Phase 1-IV) and cGMP including broad
exposure to multiple dosage forms and finished pharmaceutical products
* Experience with third party vendor auditing, out of specification
investigations, deviations, product complaints and change control
* Operational experience and technical understanding of standard
manufacturing and packaging processes for a variety of dosage forms
* Experience working with contract manufacturing organizations
* Must be able to critically evaluate completed manufacturing
documentation and assess to determine compliance with SOPs and
regulatory documents
* Experience interfacing with regulatory bodies and working on
regulatory submissions
* Good technical and QA background, having a good understanding of
analytical method development and validation and specification setting
* Knowledge of US and EU GMP guidelines and their implementation for
CMC product development

PERSONAL COMPETENCIES:

* Highly organized, with good time management and the ability to
prioritize
* Critical thinker with the ability to evaluate complex problems
* Excellent verbal and written communication skills
* Patient and results focused
* Good Leader
* Highly motivated
* Collaborative team player
* Strong work ethic with a flexible and adaptable approach
* Careful attention to detail
* Articulate, computer literate, problem solving, decision taking,
inter-personal and influencing skills
* Good people skills and experience in management of a team required
* Interpersonal skills and professional skills to interact at all
levels, including senior executives, contractors, and colleagues

Jazz Pharmaceuticals is an Equal Opportunity Employer. Overview:

Jazz Pharmaceuticals is an international biopharmaceutical company
focused on improving patients lives by identifying, developing and
commercializing meaningful products that address unmet medical needs.
We are continuing to expand our commercial product portfolio and our
research and development pipeline in therapeutic areas that can
leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology
areas in which we have a deep understanding of the patient journey and
a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If
youre looking to be a part of a company with an unwavering commitment
to improving patients lives and being a great place to work, we hope
youll explore our career openings and get to know Jazz
Pharmaceuticals.

Responsibilities:

The role of the Technical Director is to provide technical leadership
to the Quality Operations Development Projects Team to support the
Jazz development pipeline from a scientific, quality and
patient-centered viewpoint. It also includes management of development
projects within the team. The position reports to the Director of
Quality, Development Projects, Quality Operations.

RESPONSIBILITIES:

The position is responsible for the management of the day-to-day
quality activities relating to development projects and providing
technical support in relation to issues that can arise with Jazz
development products, contract manufacturing organizations and
material suppliers, to all applicable GXP standards. This role also
includes cross-functional team membership/collaboration and support
for quality aspects of CMC regulatory dossiers.

Responsible for, but not limited to:

* Provide advice on technical issues that may arise for both small
and large molecule projects including initiating/directing appropriate
risk management
* Act as a Qualified Person (QP) named on Jazz Pharmaceuticals
Manufacturing and Import Authorization (MIA) for Investigational
Medicinal Products to ensure clinical trial supply
* Provide SME technical support for the successful outcome of all
regulatory inspections, both internally and at contract manufacturers,
packagers and laboratories, as required
* Liaise with the relevant departments within the business and work
closely with the Quality Operations Development Projects Team to
ensure agreed milestones/targets are met
* Act as a quality representative on CMC Product teams for assigned
development projects
* Ensure and provide support to the Quality representatives on the
CMC Product Team(s)
* Ensure compliance of all respective contract manufacturers to both
internal Jazz requirements and country specific regulations
* Work closely with the Clinical Trial Management Supply Team to
ensure supply of clinical trial material to clinical development
programs
* Prepare and/or act as an SME for Quality Technical Agreements
within the Quality Department, as required
* Facilitate technology transfer, process scale-up and process
improvement projects i.e. assist with the transitioning of Jazz
development products from the Investigational Medicinal Product space
to Commercial Medicinal Product space
* Provide information to the Supplier Review Board in the context of
development projects
* Conduct vendor audits and vendor site visits, as required
* Review new critical regulations and guidelines, as they apply to
product development from a quality perspective, and advise and assist
with their implementation in Jazz
* Responsible for the successful, timely completion of goals and
objectives which will strengthen Jazz Quality Operations, Development
Projects team
* Provide periodic QP support within Quality Operations to support
commercial manufacture

OTHER RESPONSIBILITIES:

* Communicate, where appropriate, with all corporate personnel and
contribute to development projects, as required
* Contribute to the design and implementation of best practice
quality improvement programs and company expansion programs
* Contribute to the development of quality policies and procedures
as they relate to development products in order to ensure best
practice and compliance
* Contribute to the development of new drug products, which will
deliver a robust product pipeline without significant delays in the
regulatory approval process
* Work closely with other members of the Technical Operations group
to ensure delivery of key project objectives and timelines
* Foster a positive employee relations environment and a culture of
continuous improvement and teamwork through the use of good and
consistent management principles
* This position will require up to **Apply on the website**% travel
* Act as a Development Projects Quality representative at external
meetings

PROFESSIONAL COMPETENCIES:

* Bachelors degree in chemistry, biology, pharmacy or a related
science discipline
* Eligibility to act as a licensed Qualified Person
* **Apply on the website**+ years of practical experience in the
Pharmaceutical Industry in QA or QC role(s) with a thorough
understanding of GMP and Quality Systems as they relate to product
development
* Ideally have significant experience (**Apply on the website**
years) in drug development (Phase 1-IV) and cGMP including broad
exposure to multiple dosage forms and finished pharmaceutical products
* Experience with third party vendor auditing, out of specification
investigations, deviations, product complaints and change control
* Operational experience and technical understanding of standard
manufacturing and packaging processes for a variety of dosage forms
* Experience working with contract manufacturing organizations
* Must be able to critically evaluate completed manufacturing
documentation and assess to determine compliance with SOPs and
regulatory documents
* Experience interfacing with regulatory bodies and working on
regulatory submissions
* Good technical and QA background, having a good understanding of
analytical method development and validation and specification setting
* Knowledge of US and EU GMP guidelines and their implementation for
CMC product development

PERSONAL COMPETENCIES:

* Highly organized, with good time management and the ability to
prioritize
* Critical thinker with the ability to evaluate complex problems
* Excellent verbal and written communication skills
* Patient and results focused
* Good Leader
* Highly motivated
* Collaborative team player
* Strong work ethic with a flexible and adaptable approach
* Careful attention to detail
* Articulate, computer literate, problem solving, decision taking,
inter-personal and influencing skills
* Good people skills and experience in management of a team required
* Interpersonal skills and professional skills to interact at all
levels, including senior executives, contractors, and colleagues

Jazz Pharmaceuticals is an Equal Opportunity Employer.

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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