Quality Assurance Manager

i‑Pharm Consulting; Philadelphia (Philadelphia County); On-site; USD 99,000 - 121,000; Full time

Job summary

i‑Pharm Consulting seeks an experienced Quality Assurance Manager to lead quality systems, regulatory compliance, and product quality oversight in a regulated manufacturing environment near Philadelphia, PA. You will manage QA operations and supervise QA personnel while partnering with operations, technical teams, and regulatory authorities to drive compliance and continuous improvement.

The role focuses on ensuring timely product release, audit readiness, CAPA management, and continuous

Qualifications

• Bachelor’s degree in a related scientific field and 5+ years QA in a regulated manufacturing environment.
• Proven leadership experience with direct responsibility for QA personnel.
• Strong knowledge of GMP regulations and product release processes.
• Experience supporting regulatory inspections and external audits.
• Experience managing deviations, investigations, CAPAs, change controls, and validation activities.

Responsibilities

• Provide leadership for QA activities across manufacturing, quality systems, and product release.
• Serve as primary QA representative for customers and cross-functional teams.
• Review and approve batch documentation and final product disposition.
• Lead internal and external audits, CAPA management, and deviation handling.
• Drive continuous improvement and regulatory readiness across QA functions.
• Support regulatory submissions and technical documentation as required.

Skills

Leadership

GMP knowledge

Regulatory audits

CAPA management

Quality systems

Documentation control

Education

Bachelor’s degree in Chemistry/ Biology/ Chemical Engineering/ Pharmaceutical Sciences

Tools

GMP systems

QMS software

Electronic documentation

MS Office

Job description

LOCATION: 30 Minutes from Philadelphia, PA

SALARY: Starting at $110,000 + Bonus

We are seeking an experienced Quality Assurance Manager to lead quality systems, compliance activities, and product quality oversight within a regulated manufacturing environment. This role is responsible for managing quality assurance operations, supervising quality personnel, supporting regulatory inspections, and ensuring products are released in compliance with applicable quality standards and regulatory requirements. The successful candidate will serve as a key quality leader, partnering with operations, technical teams, customers, and regulatory authorities to drive compliance, inspection readiness, and continuous improvement.

Key Responsibilities

• Provide leadership and oversight for Quality Assurance activities across manufacturing, quality systems, and product release functions.
• Serve as the primary quality representative for customers, projects, and cross-functional teams.
• Review and approve batch documentation and perform final product disposition and release activities.
• Ensure timely product release while maintaining compliance with quality standards and regulatory requirements.
• Manage QA resources, priorities, and workflows to support manufacturing and supply chain operations.
• Lead customer, supplier, and internal audits, including audit preparation, hosting, response development, and CAPA management.
• Develop, implement, and maintain quality systems, procedures, and work instructions.
• Provide quality leadership and oversight for technology transfers, process changes, and new product introductions.
• Support regulatory inspections and act as a key liaison for interactions with regulatory agencies.
• Monitor and report quality performance metrics and key performance indicators (KPIs) to leadership.
• Review and approve change controls, deviations, investigations, CAPAs, risk assessments, and other quality system records.
• Review and approve validation, qualification, and assessment protocols and reports.
• Ensure compliance with customer quality agreements and contractual quality requirements.
• Oversee complaint handling processes, customer inquiries, and quality-related issue resolution.
• Review and approve product quality reviews, annual product reviews, and other compliance documentation.
• Provide quality review and approval of manufacturing procedures, records, and controlled documentation.
• Support regulatory submissions and quality-related technical documentation as required.
• Drive continuous improvement initiatives focused on quality system effectiveness, inspection readiness, and operational excellence.
• Promote GMP compliance and quality culture throughout the organization.
• Ensure effective environmental monitoring, quality system performance, and compliance monitoring activities.
• Collaborate closely with Manufacturing, Operations, Supply Chain, Engineering, Validation, and Regulatory teams.
• Manage departmental budgets, resources, and strategic quality initiatives.
• Ensure compliance with all applicable quality, safety, environmental, and regulatory requirements.

Leadership Responsibilities

• Lead, mentor, and develop a team of Quality Assurance and Quality Systems professionals.
• Establish departmental objectives, performance expectations, and development plans.
• Manage staffing, training, performance evaluations, and succession planning activities.
• Foster a culture of accountability, continuous improvement, and regulatory compliance.

Qualifications

• Bachelor's degree in Chemistry, Biology, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• 5+ years of Quality Assurance experience within a regulated manufacturing environment.
• Previous leadership or people management experience with direct responsibility for quality personnel.
• Strong knowledge of GMP regulations, quality systems, and product release processes.
• Experience supporting regulatory inspections and external audits.
• Demonstrated experience managing deviations, investigations, CAPAs, change controls, and validation activities.
• Experience reviewing and approving quality system and manufacturing documentation.

Desired Skills

• Thorough understanding of quality systems, regulatory requirements, and compliance expectations.
• Strong leadership, coaching, and team development capabilities.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong project management and organizational abilities.
• Effective communication and stakeholder management skills.
• Ability to influence cross-functional teams and drive quality-focused decision-making.
• Proficiency with quality management systems, electronic documentation systems, and Microsoft Office applications.
• Highly detail-oriented with the ability to manage multiple priorities in a fast-paced environment.