Quality Assurance Manager

Datwyler • Middletown, NJ

5d

About The Position

The Quality Assurance Manager supports and strengthens the site’s Quality function by ensuring that all operations comply with GMP, regulatory requirements, internal quality standards, and customer expectations. Working closely with the Director of Quality, this role oversees day‑to‑day Quality Assurance (QA) activities depending on the organization’s structure. The Quality Assurance Manager drives continuous improvement, maintains a strong quality culture, and ensures the consistent manufacture of safe, effective pharmaceutical products.

Requirements

• Bachelor’s Degree required.
• 5-7 years of relevant work experience, in a Q Manager/Engineer role
• Thorough knowledge of cGMP regulations and current industry practice
• Knowledge of ISO 9001 and ISO 15378
• Good knowledge of domain-specific legislation, standards rules and procedures
• Fluent in English, both verbal and written
• International travel propensity required

Nice To Haves

• Science or engineering-related field a plus
• Experience in customer-facing role desirable

Responsibilities

• Leads the Regulatory and External Customer Audits including preparation, execution and follow-up.
• Maintains and continuously improves the site’s Quality Management System (QMS) in alignment with ISO 9001, ISO 15378, and other applicable regulations.
• Oversees deviation management, CAPA, change control, complaints, and risk assessments, escalating critical issues to the Director of Quality.
• Ensures timely and compliant batch record review and product release processes.
• Ensures all GMP documentation is accurate, complete, and maintained according to data integrity principles (ALCOA+).
• Reviews and approve SOPs, validation protocols/reports, and quality-related technical documents.
• Provides regular compliance updates and quality metrics to the Director of Quality.
• Monitors compliance trends and implement corrective actions where needed.
• Manages and develops QA staff, providing coaching, training, and performance evaluations.
• Collaborates with the Director of Quality to set departmental goals, allocate resources, and align quality initiatives with site strategy.
• Fosters a culture of quality, accountability, and continuous improvement across the organization.
• Collaborates cross‑functionally with Production, Engineering, Supply Chain, and R&D.
• Leads quality improvement initiatives using tools such as Lean, Six Sigma, and root cause analysis.
• Identifies opportunities to streamline processes while maintaining compliance.
• Tracks and reports quality KPIs to senior leadership.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager