Senior QA & Validation Lead - C&Q (Biotherapeutics)

Johnson & Johnson Co.; Wilson (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Johnson & Johnson in Wilson, NC seeks a Senior QA Specialist - C&Q to lead QA oversight across C&Q activities for a new biotherapeutics facility. You will mentor qualification teams, drive validation, manage URS/FAT/SAT/IQ/OQ/PQ, ensure data integrity, and align with GMP/FDA/EMA requirements.

You will collaborate with Operations, Engineering, MSAT and QC to deliver compliant, ready-for-handover qualification packages and support regulatory inspections.

Qualifications

• Bachelor's degree in a scientific or engineering discipline with six (6) years of experience, or a Master's with four (4) years in the biological/pharmaceutical industry.
• QA or validation experience on C&Q projects for sterile/aseptic drug product manufacturing equipment.
• Hands-on qualification/validation lifecycle experience (URS, CARA, FAT, SAT, IQ, OQ, PQ) and cleaning/validation, including reviewing protocols and reports.
• Strong understanding of cGMP, FDA/EMA/ICH guidelines (ICH Q9(R1), Q10).
• Familiarity with EU GMP Annex 1, CCS, and related requirements.
• Risk-based C&Q/validation lifecycle principles (ASTM E2500, ISPE Baseline Guide Vol. 5, GAMP 5).
• Proficiency in CSV/validation documentation and data integrity (ALCOA+).
• Technical writing for validation/quality documents.

Responsibilities

• Represent QA on C&Q projects and provide QA oversight during qualification across the project lifecycle.
• Develop and maintain site validation Master Plan and qualification plans.
• Conduct risk assessments (FMEA/HACCP/HAZOP/ICH Q9) for equipment/utilities and review design elements.
• Review and approve URS, FAT/SAT, IQ/OQ/PQ protocols and reports.
• Ensure Good Documentation Practice and data integrity in vendor and contractor documentation.
• Oversee aseptic processing qualifications, including sterilization, VHP, media fills and visual inspection qualification.
• Support site CCS implementation and regulatory readiness for licensure and inspections.
• Collaborate with cross-functional teams to implement QA controls and process improvements.

Skills

QA/Validation

URS

IQ/OQ/PQ

GxP

Regulatory knowledge

Documentation

Education

Bachelor's degree in science/engineering

Tools

Kneat

CSV/CSA

21 CFR 11

Job description

Johnson & Johnson in Wilson, NC seeks a Senior QA Specialist - C&Q to lead QA oversight across C&Q activities for a new biotherapeutics facility. You will mentor qualification teams, drive validation, manage URS/FAT/SAT/IQ/OQ/PQ, ensure data integrity, and align with GMP/FDA/EMA requirements.

You will collaborate with Operations, Engineering, MSAT and QC to deliver compliant, ready-for-handover qualification packages and support regulatory inspections.