Quality Npi Technical Lead

Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.

Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.

The company has sites/offices in China, US, EU and Asia.

The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.

Job description: 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, c GMP, CMC regulatory and client requirements.

Communications and Management: Formally manage communications between Client and Wu Xi.

Support Investigations: Support Product/Process Quality Investigations, Deviations and Capas as required.

Organization Description Wu Xi Biologics is a premier provider of biologics services (from discovery to commercialization) with global clients 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 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 youll 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, youwill carry out essential duties.

Leading QA oversight of all New Product Introduction, Technology Transfer and Product Continual Improvement teams, to ensure compliance to SOPs, c GMP 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 Wu Xi 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 withc GMPs, 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 tofacilitaterelease of pre-approval PPQ batches following receipt of regulatory dossier/variation approval.

Prepare APQRs for the products manufactured by Wu Xi 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 Leadto 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 Clientin 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 toensure 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 rightfirst-time culture within the organisationregardingtechnical review and implementation.

Your Profile: The ideal candidate for this position, will have the following: Qualifications: Advanced degree (Bachelor, Master, or Ph D) in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, orotherrelated fields.

Knowledge/Experience: At least 10 years relevant work experience in Bio Pharma 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 communicationskills withdemonstratedability 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- dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

Apply now Wu Xi Biologics is an equal opportunities employer.

Would you like to know more before you apply? Please visit us ator contact us via Skills: NPI Leadership Quality Product Release Analytical Benefits: Bonus Parking Pension Sports & Social Club VHI

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