Job Opportunity

Job Opportunity

Quality NPI Technical Lead - Associate Director

Quality NPI Technical Lead - Associate Director

Ireland Posted 2025-04-09

QA NPI Technical Lead – Associate Director

We are seeking a highly skilled QA Technical Lead to join our team. In this role you will ensure that new products meet quality standards, client expectations and regulatory requirements by overseeing the Quality Strategy throughout the NPI lifecycle. This will be achieved by ensuring:

Compliance driven decisions are executed throughout the New Product Introduction lifecycle.
Risk Identification and Mitigation: Identify and mitigate New Product/Process Quality and Compliance Risks.
Adherence to Standards: Ensure all NPI and related activities are executed in accordance with site/corporate SOPs, cGMP, CMC regulatory and client requirements.
Communications and Management: Formally manage communications between Client and WuXi.
Support Investigations: Support Product/Process Quality Investigations, Deviations and Capa’s as required.

Organization Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global clients in the biopharmaceutical and healthcare industries. We´re 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 and Asia. 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 Technical Lead you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.

Your Responsibilities

In this role, you will carry out essential duties.

Leading QA oversight of all New Product Introduction, Technology Transfer and Product Continual Improvement teams, to ensure compliance to SOPs, cGMP and CMC regulatory requirements as well as acting as a Quality advocate for consistency and harmonisation across specifications, analytical methods, and manufacturing processes.
Be the technical lead between local QA, QC, QPs and the Client for product quality investigations, deviations, CAPAs and Master batch record review.
Lead Quality role in the Technology Transfer for products to WuXi Biologics facility. Be the lead QA reviewer/approver of Technology Transfer and post-approval change documentation, including but not limited to TTMP, PD, sampling plan, BOMs, MBRs, etc., to ensure compliance with cGMPs, CMC Regulatory and Client requirements.
Execute a leadership role with Quality colleagues and other stakeholders on product quality investigations, critically assess and challenge impact assessments for effectivity and compliance to applicable regulatory requirements.
Play a significant role in the formal review and approval of gap assessments and/or comparability reports to facilitate release of pre-approval PPQ batches following receipt of regulatory dossier/variation approval.
Prepare APQRs for the products manufactured by WuXi Biologics Ireland, manage with the individual section authors and with the Client reviewer/approver, raise CAPAs, as required, and track to closure.
Collaborate with the Client Quality Lead to ensure that the requirements of the Client Quality Agreements are met, including maintenance of supply chain maps and communication of changes and quality events to the Client in a timely manner.
If required, perform quality review of CMC sections of regulatory submissions and responses to queries. Facilitate management and closure of post-marketing regulatory commitments through the site change control system.
To support site audit ready status, lead the QA technical function to ensure full compliance at all times.
Take a leadership role in coaching and mentoring cross functions in the technical analysis and requirements to ensure compliance and improved impact assessments. Drive and lead right first-time culture within the organisation regarding technical review and implementation.

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:

At least 10 years relevant work experience in BioPharma industry, preferably Validation, Quality or MSAT roles.
Must be familiar with EMA & FDA regulations; ICH and WHO guidelines – Preferable knowledge of CMC stage gates and submission types.

Behavioural Competencies

Proven ability to lead projects and inspire cross functional teams.
Effective at managing and influencing stakeholders.
Demonstrated Problem Solving with growth mindset.
Strong communication skills with demonstrated ability to work in a matrix environment.
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!

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 - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now!

WuXi Biologics is an equal opportunities employer.

Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com

Apply now