Quality Assurance Manager (Pharmaceutical)

Location: Pennsville, New Jersey, United States; onsite

Salary: $105,000–$135,000 per year

Company

hirify.global is a global pharmaceutical contract development and manufacturing organization that develops and manufactures APIs and finished dosage forms across 16 sites.

What you will do

• Manage all aspects of site Quality Assurance and supervise 5–10 QA/Quality Systems Specialists.
• Lead product quality decisions, batch release, product oversight, customer quality communications, and complaint management.
• Direct internal and external audits, author responses, and ensure completion of associated CAPAs.
• Manage regulatory inspection readiness, inspection communications, risk mitigation, and GMP compliance.
• Review and approve change controls, deviations, investigations, CAPAs, SOPs, production records, executed logs, and product quality reviews.
• Lead validation, qualification, technology transfer, environmental monitoring, KPI reporting, budgeting, and continuous improvement activities.

Requirements

• Bachelor’s degree in Chemistry, Chemical Engineering, or an equivalent technical field, and/or 5–10 years of pharmaceutical Quality Assurance experience.
• 2–5 years of leadership experience and in-depth knowledge of cGMP in a manufacturing environment.
• Excellent verbal and written communication, coaching, interpersonal, and project management skills.
• Ability to work effectively with people at all levels and from diverse cultures.
• Conscientious, detail-oriented, self-starting, and collaborative approach.
• Ability to supervise staffing, performance management, and training for QA/Quality Systems Specialists.

Culture & Benefits

• Performance-based bonus.
• Employee Share Matching Plan.
• 401(k) match.
• Medical, dental, vision, life, sickness and accident insurance, and long-term disability coverage.
• Optional increased voluntary life insurance for employees and families.
• Workplace accommodations are available for qualified individuals with disabilities.