Director, 211 Manufacturing Quality & Regulatory (Remote)

ADP, Inc.; United States; Remote; USD 171,000 - 209,000; Full time

Job summary

PharmaLogic is seeking a Director, 211 Manufacturing Quality and Regulatory to provide governance for US facilities, manage the Quality Management System, and lead regulatory activities under 21 CFR Parts 210 and 211. This remote role covers the West Coast and Rocky Mountain region with a focus on QA, compliance, and inspections leadership.

You will build and mentor teams, ensure readiness for inspections, and drive continuous improvement across all 211 operations and client programs in a

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Advanced degree preferred (MS, PharmD, or PhD).
• Minimum 10 years of progressive experience in pharmaceutical/biotech manufacturing.
• Minimum 5 years of quality leadership experience.
• Experience within a CDMO or regulated healthcare manufacturing environment in a 211 environment.
• Proven success leading FDA inspections and regulatory interactions.
• Experience implementing and maintaining a robust Quality Management System.
• Multi-site quality oversight and startup/rapid-growth manufacturing environments.

Responsibilities

• Provide Quality and Regulatory governance for US facilities, projects, technology transfers, client programs, and manufacturing activities operating under 21 CFR Parts 210 and 211.
• Lead and maintain the Quality Management System (QMS) in compliance with FDA cGMP requirements, applicable USP standards, ICH guidelines, and applicable federal and state regulations.
• Provide Quality Unit leadership and authority consistent with 21 CFR Part 211 requirements, including escalation of significant quality and compliance risks.
• Establish Quality governance and readiness criteria for new and existing 211 operations, including facility startups, technology transfers, and validation activities.
• Maintain regulatory and inspection readiness across all 211 facilities and serve as the primary contact for Quality and Regulatory matters.
• Lead regulatory inspections and audit responses, including FDA Form 483 responses and CAPA closure.
• Monitor evolving regulatory requirements and translate changes into Quality System improvements.
• Provide oversight of GMP manufacturing, labs, validation, and supplier quality activities.
• Serve as senior Quality and Regulatory partner for CDMO clients and lead regulatory submissions and inspections.
• Lead Quality Agreement development with sponsors and GMP providers.
• Establish Quality Management Review and continuous improvement initiatives with KPI tracking.
• Build and mentor high-performing Quality and Regulatory teams across US operations.

Skills

Leadership

Regulatory compliance

Quality management

GMP knowledge

Audit/regulatory inspections

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred (MS, PharmD, or PhD)

Job description

PharmaLogic is seeking a Director, 211 Manufacturing Quality and Regulatory to provide governance for US facilities, manage the Quality Management System, and lead regulatory activities under 21 CFR Parts 210 and 211. This remote role covers the West Coast and Rocky Mountain region with a focus on QA, compliance, and inspections leadership.

You will build and mentor teams, ensure readiness for inspections, and drive continuous improvement across all 211 operations and client programs in a