Site Quality Head

WuXi Biologics Group; The Municipal District of Dundalk; On-site; EUR 90,000 - 120,000; Full time

Job summary

WuXi Biologics Group is hiring a Site Quality Head in Dundalk, Ireland. This pivotal role involves structuring the quality strategy aligning with global objectives and regulatory requirements. The incumbent will provide leadership to the Quality organization, ensure compliance with industry standards, and drive continuous improvement initiatives. The successful candidate will have over 15 years of quality experience, strong leadership skills, and an advanced degree in a relevant field. Travel may be required.

Qualifications

• Over 15 years relevant work experience in quality.
• 10 years of managerial experience.
• Experience in pharmaceutical industries, preferably Biologics.

Responsibilities

• Provide technical and managerial leadership to the site Quality organization.
• Drive quality system development and improvement.
• Lead quality oversight of site operations.
• Ensure compliance with cGMP regulations and internal standards.
• Lead regulatory inspections and audits.

Skills

Leadership

Communication

Analytical Skills

Decision Making

Strategic Thinking

Education

Advanced degree in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering or related fields

Job description

The Site Quality Head will play a pivotal role in structuring and reimagining Dundalk site’s 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 organization's capabilities in meeting business objectives and site strategy

Responsibilities

• 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.
• Develop the overall Quality strategy aligned with the site’s 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 site’s 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 team’s 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.

Profile

Qualifications

• Advanced degree (Bachelor, Master, or PhD) in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or other related fields.

Knowledge and Experience

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

WuXi Biologics is an equal opportunities employer.