Sr Mgr Product Quality Integrator (Biotherapeutics)

Location: European sites, including Little Island, Cork, Ireland; Leiden, Netherlands; and Schaffhausen, Switzerland. Up to 10% domestic and international travel may be required. Flexible hours are needed to accommodate US, EMEA, and APAC work schedules.

Company

Johnson & Johnson develops healthcare solutions through its Innovative Medicine and MedTech businesses.

What you will do

• Own the end-to-end quality strategy and quality aspects for assigned biotherapeutic products from early development through commercialization and late-stage lifecycle management.
• Represent Global Quality on CMC and Value Chain teams and act as the primary quality liaison with analytical groups and sites.
• Ensure quality stage-gate deliverables and product quality development throughout the product lifecycle.
• Review and approve health authority submissions, including IND, IMPD, BLA, NDA, and MAA filings, and support agency audits and inspections.
• Lead quality integration teams covering clinical development, drug substance, drug product, devices, and packaging.
• Coordinate quality issue resolution with external manufacturers and business partners and drive global quality alignment.

Requirements

• Bachelor’s degree or university equivalent in pharmacy, biology, biochemistry, biotechnology, engineering, or a similar technical or scientific discipline.
• At least 8 years of experience in the pharmaceutical or biotechnology industry.
• Knowledge of cGMP standards, policies, and procedures.
• Ability to work across organizational boundaries through presentation, influencing, negotiation, and partnering.
• Ability to assimilate new technologies, perform risk assessments, and develop action plans.
• Experience with quality processes, regulatory filings, inspections, or manufacturing quality systems is relevant to the role.

Nice to have

• Master’s degree or another advanced degree.
• Knowledge of biotech, biotherapeutics, or sterile pharmaceutical manufacturing.
• Experience with technology transfer, process development, or process validation.
• Understanding of change control, event handling, CAPA, risk management, and manufacturing control strategies.
• Experience with drug substance, drug product, and device stability.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and employee recognition.
• Annual bonus with a target based on pay grade and location.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Insurance plans, service anniversary awards, and recognition awards may be available according to local plan terms.