Quality Director of Operations

Quality (QA) Director of Operations

The QA Director of Operations will play a pivotal role in ensuring the highest standards of professional excellence and quality within the business with overall responsibility for ensuring the quality assurance of WuXi Biologics Dundalk while adhering to all regulatory cGMP and company requirements. Lead a cross functional team of QA leaders and professionals. Supports the governance coordination and management of Quality Management System (QMS) and QA Drug Substance Manufacturing. Provides expert guidance on all matters pertaining to Quality Assurance within a Drug Substance Manufacturing facility.

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 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 this role you will report to the Site Quality Head.

Your Responsibilities

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

• Provide leadership in all areas of quality assurance management. Ensure development of robust systems and processes.
• Key role in developing a Quality culture for the Dundalk Biologics Manufacturing site.
• Develop operational quality strategic plan for the site readiness and establish robust plans to support manufacturing of high quality and safe products.
• Develop and build a strong QA team ensuring high performance and collaboration including planning recruiting/hiring coaching/mentoring and training all employees.
• Oversee the site Quality Assurance operations during the full manufacturing process.
• Work closely with functional directors or designees to ensure safe & efficacious products are produced and released.
• Ensure compliance with relevant regulatory authorities requirements and high-quality standards.
• Host and lead regulatory inspections & client audits periodically ensure compliance is adhered to at all times and an audit ready culture is maintained constant.
• Interact with external & internal customers & ensure solutions focused approach to quality challenges ensure timely resolution of challenges which may arise.
• Prepare and manage teams financial budget and maintain operating costs accordingly. Ensure accurate and timely reporting.
• Create a safety culture advocate safety measures and ensure all staff are working in a safe environment
• Perform all duties in accordance with GMP requirements SOPs and controlled documents.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Site Quality Head.
• Will act as a role model for the Quality Assurance function and also 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

• Degree in Biopharmaceutical/Pharmaceutical Science or other related science discipline is essential.

Knowledge/Experience:

• 15yrs experience within the Biopharmaceutical and/or pharmaceutical manufacturing industry within a senior Quality Assurance role is required experience within Biopharma is preferred.

• Previous experience leading a team of QA professionals is essential.

• Strong knowledge of ICH and GMP Guidelines required.
• Proven track record of accomplishments within the Quality Assurance and GMP area

• Must be familiar with requirements of EMA and FDA regulations.

Behavioural Competencies

• Proactive and extraordinary leadership skills.
• Excellent interpersonal and communication skills.
• Able to think critically and demonstrate troubleshooting and problem-solving skills.
• Excellent verbal and written communications skills in English.
• Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
• Results and solutions oriented.

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.