Senior Product Quality Integrator – Biotherapeutics Launch

Johnson & Johnson Innovative Medicine; Titusville (NJ); On-site; USD 122,000 - 213,000; Full time

Benefits offered by this job

Paid time off

Parental Leave

Health benefits

Job summary

Johnson & Johnson Innovative Medicine is recruiting a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. Based at US sites including Titusville, NJ, you will own the quality strategy from early development through commercialization for large molecule products.

You will lead QA teams, interact with CMC and regulatory functions, and drive quality across launch activities. The role requires extensive experience in pharma/biotech quality, cGMP, and regulatory submissions,

Qualifications

• Requires strong communication across organizations and with regulators.
• Experience with risk assessment and action planning.
• Knowledge of cGMP standards, policies and procedures.
• Ability to work across boundaries and manage multiple sites.

Responsibilities

• Represent Global Quality on cross-functional teams and ensure QA deliverables.
• Approve health authority filings and support audits.
• Define QA resources for global and local product quality.
• Lead quality integration teams through development to launch across large molecules.
• Coordinate complaints trend investigations and corrective actions.
• Maintain communication between Global Quality and Value Chain teams.
• Prepare quality sections of product strategy and end-to-end mapping.

Skills

Communication

Risk assessment

Project management

Quality systems

CMC knowledge

Education

Bachelor's degree in Pharmacy/Biology/Biochemistry/Biotechnology/Engineering

Job description

Johnson & Johnson Innovative Medicine is recruiting a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. Based at US sites including Titusville, NJ, you will own the quality strategy from early development through commercialization for large molecule products.

You will lead QA teams, interact with CMC and regulatory functions, and drive quality across launch activities. The role requires extensive experience in pharma/biotech quality, cGMP, and regulatory submissions,