Associate Quality Manager - Life Science Division

Langham Logistics•Easton, PA

About The Position

The GMP QA Associate Manager leads daily quality operations in the Pharmaceutical Raw Material Warehouse and Sampling Suite. The role ensures compliance with GMP, regulatory agency, and client-specific requirements while overseeing Quality Associates who receive, inspect, sample, and test raw materials and components. It also ensures cleanroom and sampling activities are conducted under controlled conditions to safeguard product integrity and prevent cross-contamination. The Associate Manager manages team performance and workforce planning and serves as a liaison between Quality, Warehouse, and Operations to support timely resolution of material quality issues, deviations, and client inquiries. The role supports audits, continuous improvement initiatives, and cross-functional projects to strengthen compliance and operational efficiency. It also ensures adherence to safety, security, and regulatory requirements, including hazardous-material requirements and applicable DHS and FDA guidelines, while embodying the company’s values of teamwork, accountability, integrity, communication, and respect.

Requirements

Bachelor’s degree in a scientific or technical discipline, such as Biology, Chemistry, or Pharmaceutical Sciences, or equivalent experience.
At least 3 years of Quality experience in a pharmaceutical manufacturing or distribution environment.
Strong knowledge of GMP regulations, including FDA, EU, and ICH requirements.
Previous supervisory or managerial experience.
Strong understanding of current Good Manufacturing, Good Distribution, and Good Documentation Practices (GMP/GDP) as applied to raw materials and pharmaceutical distribution operations.
Proficient computer skills, including Microsoft Office.
Planning and organizational skills to manage a dynamic environment with shifting priorities.
Ability to assess situations, evaluate risks, and implement effective, compliant solutions in a GMP environment.
Ability to communicate effectively, verbally and in writing, with internal and external teams.
Analytical skills to assess information and data and make decisions about potential product-quality risks.
Ability to establish professional relationships and rapport with internal and external peers and management.
Ability to anticipate potential product and operational problems and risks and investigate solutions.
Ability to manage multiple quality records with varying due dates, ensure timely completion, and maintain records in a readily retrievable format.
Ability to bend, stoop, and lift up to 50 pounds as part of the daily work routine.

Responsibilities

Lead, mentor, and develop a team of Quality Associates working in the Pharmaceutical Raw Material Sample Suite.
Promote a culture of compliance, accountability, and continuous improvement.
Ensure sampling, inspection, and testing activities comply with GMP, FDA, and client requirements.
Oversee cleanroom operations, including gowning, trafficking, cleaning, environmental monitoring, and contamination control.
Manage and support quality system processes, including deviations, CAPA, change control, investigations, and training related to the Sample Suite.
Review and approve quality records for completeness, accuracy, and regulatory compliance.
Oversee quality checks for incoming raw pharmaceutical materials and sampling processes to ensure product integrity and traceability.
Collaborate with Warehouse and Operations to resolve material discrepancies and quality-related issues.
Serve as the primary quality contact for internal and external audits and inspections related to the Sample Suite.
Communicate with clients about quality issues in a timely and accurate manner, in alignment with SOPs and Quality Agreements.
Identify process gaps and lead initiatives to improve operational efficiency and regulatory compliance.
Conduct risk assessments to support decision-making and robust quality oversight.
Ensure compliance with safety protocols and hazardous-material handling guidelines.
Adhere to security requirements mandated by DHS, FDA, and other regulatory authorities.
Manage team performance and workforce planning.
Support continuous improvement initiatives and cross-functional projects.