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QA Director of Operations

1 month ago

Dundalk, United States Acttif Full time

Career Opportunities: QA Director of Operations (2526)

Requisition ID

2526

- Posted -

Dundalk, IRL

-

Ireland
The QA Director of Operations will play a pivotal role in the Quality leadership team. The QA Director will direct quality oversight of products manufactured and tested in WuXi Biologics Ireland from introduction through to product release They will

be responsible for

all aspects of Quality activities associated with daily operations and future site and global strategic design. The QA Director will proactively

identify

and minimize product quality and compliance risks by

establishing

a Quality strategic plan, while developing and embedding Quality Standards, Policies and Culture both in the presence and absence of the

Senior Quality Director

.
Organization Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia, and Israel. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.
Department Description
As QA Director of Operations, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting to the Senior Quality Director.
Your Responsibilities
E ssential duties and responsibilities of this role include and are not limited to the following;
Key member of the Quality Leadership and Site Leadership Team

. Be a strong delegate for the

Senior Quality Director.
Responsible for all aspects of quality associated with the manufacturing and release of medicinal products.
This role will lead and manage multiple key quality functions including Quality Management System, Quality Qualification & Validation, Quality Client Management, Quality Drug Substance Operations

.
They will be accountable for the oversight of activities to ensure compliance to SOPs, cGMP and CMC regulatory requirements as well as acting as a Quality advocate for the Quality Department

.
The role will require extensive liaison with counterparts,

business, and quality leaders across WuXi Biologics (Local and Global reach). This will require the highest level of professional representation of the local site Quality organisation.
Partner with Quality colleagues and other business stakeholders to provide leadership and direction on product quality investigations, critically assess and support impact assessments were needed and liaise with QP, Client and/or CMC regulatory affairs

with regard to

mitigations such

as

change controls, variations etc.
In collaboration with the

Senior Quality Director

and relevant colleagues across Local and Global Quality, develop and implement the strategic

objectives

for the Quality organisation inclusive of headcount

management, and budget

design.
Build and develop a high performing Quality management team, including attracting and

maintaining

a strong talent pipeline from within and beyond the

WuXi network

.
This role will be accountable for Quality Organisational design, to ensure

optimum

structure to achieve quality compliance. This role will work closely with counterparts and peer companies to ensure best in class industry standards are achieved and aligned.
Working with the

Senior Quality Director

To ensure

accurate

, relevant reliability and metrics are in place as key Quality performance indicators.
Ensure that sites quality standards, practices, procedures, and documentations are

in accordance with

cGMP regulations, pharmacopoeia, and corporate global, regional, & the site requirements, industry standards and best practices
This role will support the culture of Quality on site and drive improvements in all areas of compliance and setting expectations and

standards

for adherence

. Create a culture of audit readiness

.
Key leader in ensuring regulatory compliance and achievement of licences associated with manufacturing of bioproducts

. Establish site strategy to ensure continuous compliance to regulatory and client expectations.
Drive quality system development,

establishment,

and improvement for Dundalk

Biologics

Manufacturing site.
Ensure the engagement of the Quality Assurance organization with Learning and Development initiatives and the performance management system for the site

.
Ensure adherence to all safety and quality

standards

.
Will be flexible to take on

additional

tasks and responsibilities at the discretion of the

Senior Quality Director

.
Act as a role model for the Quality Organisation Speak with one quality voice and

demonstrate

PROUD values and

behaviours

.
Your Profile
The ideal candidate for this position, will have the following:
Qualifications
Advanced degree (Bachelor,

Master, or PhD) in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or other life science related fields

.
QP Qualified Highly Desirable

.
Knowledge/Experience:
At least 1520 years relevant work experience in quality and leadership experiences in pharmaceutical industries.
Demonstrated examples of deliverance and compliance success.
Must be familiar with EMA & FDA regulations; ICH and WHO guidelines

.
Must have a proven

track record

of

extensive knowledge

and experience gained within the biopharmaceutical/pharmaceutical industry sector.
Proven risk management

Identification

and Control

.
Excellence in leadership,

providing

clear direction and focus to the Quality team and wider business functions.
Proven ability in leading high performing teams, setting the highest professional standards.
Ability to interact well with all levels of staff, including senior management with excellent

problem-solving

capabilities.
A strong work ethic with a proven

track record

identifying

continuous improvement opportunities within the Quality function and beyond.
Excellent analytical and project management skills with ability to handle multiple projects at once. Excellent strategic

decision-making

capabilities.
Excellent business acumen/commercial awareness.
Other Requirements:
Must be willing to travel as required internationally to fulfil the responsibilities of the position

.

Delegation of Responsibilities:
When absent from the site duties and responsibilities will be delegated to the following designates:
Job Title

: Senior Quality Director
Job Title

:

QA Drug Substance Operations Lead
Job Title

:

QMS Lead
Job Title

:

QAV Lead
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential.
WuXi Biologics is an equal opportunities employer.

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