Senior Manager, Quality Asset Management (Biotech)

Location: Titusville, New Jersey; Raritan, New Jersey; Malvern, Pennsylvania; or Spring House, Pennsylvania, United States. The role may also be posted for Belgium, Ireland, or Switzerland. Up to 10% domestic and international travel may be required. Flexible hours are needed to support US, EMEA, and ASPAC schedules.

Base pay: $122,000–$212,750 per year.

Company

Global healthcare organization developing innovative medicines, medical technologies, and advanced therapy solutions.

What you will do

• Own the quality strategy and quality aspects of Advanced Therapies products from early development through commercialization.
• Represent Global Quality on CMC and Value Chain Teams and act as the primary quality liaison for analytical and cross-functional groups.
• Ensure quality stage-gate deliverables, new product integration, lifecycle quality activities, and site alignment are completed.
• Review and approve regulatory submissions and health authority responses, and support inspections, audits, and product quality activities.
• Lead quality issue resolution with sites, external manufacturers, business partners, and product safety teams.
• Drive risk-based decisions, quality strategies, business continuity activities, and control-strategy development for new products.

Requirements

• Bachelor’s degree 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 present, influence, negotiate, partner across organizational boundaries, assess risks, and develop action plans.
• Availability for flexible working hours across US, EMEA, and ASPAC schedules and up to 10% domestic and international travel.

Nice to have

• Master’s degree or another advanced degree.
• Experience with biotech, vaccine, or sterile pharmaceutical manufacturing.
• Experience in technology transfer, process development, or process validation.
• Knowledge of change control, event handling, CAPA, risk management, manufacturing control strategies, and quality management systems.
• Experience with regulatory filings, inspections, preparedness activities, and API or drug product stability.

Culture & Benefits

• Full-time employment with pension and 401(k) savings plan eligibility.
• Eligibility for a long-term incentive program.
• Paid vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, and volunteer leave.
• Inclusive work environment with accommodation support available during the interview process.