QA Lead - DS/DP Manufacturing

at  WuXi Biologics

COMPANY DESCRIPTION

WuXi Vaccines, a subsidiary of WuXi Biologics, focuses on human vaccine discovery, development and manufacture. An exciting new addition to the WuXi Biologics family, WuXi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business model on which WuXi Biologics reputation is based. In development is an integrated vaccine manufacturing facility with 240 million US Dollar investment, including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC), dedicated to manufacturing our partner’s vaccine products for the global market.

JOB SUMMARY

You will be responsible and accountable for ensuring GMP production quality system in place adhering to all regulatory, cGMP and company requirements. Ensure all structures are in place to monitor, measure and ensure successful programme is applied.
You will be responsible to ensure all necessary plans and standards are achieved consistently maintaining a high level of quality.

REQUIREMENTS

• Knowledge of legislative, regulatory, market, biologics and data integrity requirements.
• Preferable to have qualification Degree in Biopharmaceutical Science or other related science discipline.
• Relevant experience in vaccine/bio-pharma or similar experience in a pharma/science background.
• Strong communication skills with demonstrated ability to work in a matrix environment.
• Strong leadership competencies with demonstrated 5+ years management experience.

• Act as site QA responsible for on-site quality monitoring of DS/DP manufacturing and participant in GMP production activities, such as process transfer, validation etc.
• Close monitoring the construction quality of GMP production.
• Support CQV activities as necessary.
• Work with functional department to create department SOPs and assure alignment with WuXi corporate policies.
• Audit quality documents of functional department to assure data integrity and provide guidance from QA perspective.
• Support site GMP Readiness preparation activities, including internal self inspection programme.
• Responsible for establishing DS/DP QA team, including online support.
• Work closely with other team, to support all GMP production activities.
• Perform routine audit for manufacturing area, to assure GMP production in compliance with all regulatory, market, EU, FDA and company standards.
• Responible to review and approve manufacturing generated documents, including but not limited to qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, change control, QRM, etc.
• Ensure accurate reporting of Manufacturing generated results and assure data integrity in daily activity.
• Responsible for managing a team of employees across QA for DS/DP. Ensure all associated performance management requirements are in place for each employee and relevant reviews are completed regularly.
• In addition, you will be responsible to ensure relevant training is provided to employees who carry out DS/DP duties to ensure site SOPs are followed, accurate identification of deviations or any other quality issues.
• Liaise actively with cross functional teams for release DS/DP, including preparation of all documentation necessary for QP release.
• Other quality activities which supervisor assigns
• Delegation of responsibilities to Sr. Specialist, QA for DS/DP