Site Quality Head

Site Quality Head

The Site Quality Head will play a pivotal role in structuring and reimagining Dundalk sites quality strategy in line with global strategy and regulatory expectations. The Site Quality Head will lead and oversee all necessary standards to consistently maintain a high level of quality. Develop long-term development and succession plans to anticipate and improve the Quality organizations capabilities in meeting business objectives and site strategy

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 worlds 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.

Department Description

As Site Quality Head you will join an organization where people of all backgrounds and experiences are respected and where we work together focused on changing this role you will report to the Head of Global Quality Department.

Your Responsibilities

Essential duties and responsibilities of this role include and are not limited to the following;

• Provide technical and managerial leadership to the site Quality organization including QA Operations Quality Systems & GMP Compliance and QA Validation groups QPs and QC laboratories.
• Drive quality system development establishment and improvement for Dundalk Biologics Manufacturing site.
• Key member of the local site leadership team for WuXi Biologics Ireland. Play an integral role in the strategy and business planning processes ensuring cross functional collaboration and leadership execution.
• The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the local site.
• Develop the overall Quality strategy aligned with the sites strategic business plans and global Manufacturing strategy.
• Lead the quality oversight of site operations such as manufacturing product release process quality quality control quality systems qualification & validation.
• 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.
• Lead the site regular quality management reviews.
• Lead regulatory inspections & client audits and maintain a state of inspection readiness.
• Interact with internal & external customers & resolve quality issues in timely manner.
• Working with Global Quality Compliance to define the site Quality Key Performance Indicators (KPI); Measure the Quality teams performance against KPIs.
• Ensure the engagement of the team with Learning and Development initiatives and the performance management system for the site.
• Develop a culture of continuous improvement recognition and constructive feedback for the team; Build and develop a high performing quality organization including the attraction development and retention of talent.
• Act as a role model for the Quality function and the wider organization in adherence to the WuXi corporate core values local site shared commitments/behaviours.
• Propose Quality budget & maintain Quality operating costs within the approved budget.
• Perform all duties in accordance with GMP requirements SOPs and controlled documents.
• Flexibility to take on additional tasks and responsibilities at the discretion of the Head of Global Quality Department.
• Will act as a role model for the Quality function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

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 related fields.

Knowledge/Experience:

• Over 15 years relevant work experience in quality; 10 years of managerial experiences; 15 years of experience in pharmaceutical industries; Experience in Biologics is preferable.
• Must be familiar with EMA & FDA regulations; ICH and WHO guidelines.

Behavioural Competencies

• Strong communication skills with demonstrated ability to work in a matrix environment.
• Excellent leadership skills
• Strong analytical skills
• Strong decision maker based on risk level is a key competency of this role.
• Result and solution focused.
• Strategic thinker with drive for business continuous improvement and customer focused.

Other Requirements:

• Must be willing to travel as required internationally to fulfil the responsibilities of the position.

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! Apply now!

Would you like to know more before you apply Please visit us at or contact us via

WuXi Biologics is an equal opportunities employer.