Global Product Quality Integrator - Biologics

Regulatory Jobs; Malvern (Chester County); On-site; USD 122,000 - 213,000; Full time

Job summary

Johnson & Johnson's Janssen Pharmaceutical Companies seeks a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics, to own quality strategy from development through commercialization for large-molecule products. The role is located at multiple U.S.

sites, including Titusville, Horsham, Malvern, or Chesterbrook, PA, with international travel as needed. The position requires 8+ years in pharma/biotech, strong cGMP knowledge, and the ability to lead cross-functional teams.

Qualifications

• Bachelor’s degree in a technical/scientific field (pharma/biology/biotech/engineering)
• Minimum 8 years of experience in pharmaceutical or biotechnology
• Knowledge of cGMP standards, policies and procedures
• Ability to work across organizational boundaries through presenting, influencing, negotiation and partnering
• Willingness to work across US/EMEA/APAC time zones; up to 10% travel
• Location options include Cork, Leiden, Beerse, Schaffhausen, Titusville, NJ; Horsham, PA; or Chesterbrook, PA

Responsibilities

• Represents Global Quality on CMC and Value Chain Teams; liaises between VCT and Analytical group
• Ensures Quality stage gate deliverables are achieved
• Quality reviewer/approver of health authority submissions and questions; supports audits
• Defines and oversees QA resources for global and local QA of assigned products
• Leads QA integration team from development through launch for large molecules
• Leads QA sub-team across clinical, DS, DP, FF & device; ensures quality through Launch and Grow
• Ensures standard Global Quality processes across sites; manages PPQS prep and criticality analyses
• Represents Global Quality on Value Chain Teams; aligns strategy with corporate/regulatory plans
• Presents project updates to Quality Management; escalates issues; engages IMTs; supports recalls

Skills

cGMP knowledge

Cross-functional work

Regulatory filings

Risk assessment

Communication & leadership

Education

Bachelor’s degree in a technical/scientific field

Master’s degree preferred

Job description

Johnson & Johnson's Janssen Pharmaceutical Companies seeks a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics, to own quality strategy from development through commercialization for large-molecule products. The role is located at multiple U.S.

sites, including Titusville, Horsham, Malvern, or Chesterbrook, PA, with international travel as needed. The position requires 8+ years in pharma/biotech, strong cGMP knowledge, and the ability to lead cross-functional teams.