Principal QC Specialist – Raw Materials & Compendial

About the role

WuXi Biologics seeks a senior Quality Control professional to lead Raw Materials and Compendial testing activities. The role combines hands‑on laboratory expertise with people‑management and continuous‑improvement responsibilities.

Key responsibilities

• Lead and develop the Raw Materials and Compendial testing teams, handling hiring, onboarding, mentoring and performance reviews.
• Plan daily work schedules, assign resources and ensure timely delivery of test results.
• Partner with the QC Head on budgeting for manpower, supplies and equipment.
• Oversee all testing activities, establish operational metrics and service KPIs, and drive continuous‑improvement initiatives.
• Provide guidance on analytical method qualification/validation, review SOPs, validation protocols, investigations and specifications.
• Ensure compliance with GDP, cGMP, CFR and PIC/S guidelines and act as the site point of contact for RM and compendial topics.

Required profile

• Bachelor’s or advanced degree in Chemistry, Microbiology, Biochemistry or related field.
• 6‑8 years of QC experience in the biopharmaceutical industry plus at least 2 years of management experience.
• Strong knowledge of GMP, ICH regulations and pharmacopoeial (EP/USP/ChP) requirements for raw materials.
• Hands‑on expertise in pharmaceutical raw‑material control and compendial testing.

Required skills

• GMP, cGMP and ICH regulatory knowledge.
• Compendial testing techniques (pH, osmolality, clarity, extractable volume, visible/subvisible particles, color).
• Analytical method qualification and validation.
• Root‑cause analysis and investigation execution.
• Quality‑system tools (document management, change control, deviation and CAPA handling).