Remote Director, 211 Quality & Regulatory (CDMO)

PharmaLogic; United States; Remote; USD 171,000 - 209,000; Full time

Benefits offered by this job

401(k) retirement benefit program

Medical

Dental care

Disability insurance

Employee assistance program

Extended health care

Life insurance

Paid time off

Vision care

Job summary

PharmaLogic is seeking a Director of 211 Manufacturing Quality & Regulatory to lead quality governance for US operations, facilities, and client programs subject to 21 CFR Parts 210 and 211. This role oversees the QMS, regulatory compliance, inspection readiness, and continuous improvement across radiopharmaceutical manufacturing.

The incumbent will guide quality leadership, ensure FDA readiness, manage multi-site quality oversight, and serve as the primary liaison during inspections and

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• Minimum 10 years in pharmaceutical/biotech radiopharmaceutical manufacturing.
• Minimum 5 years of quality leadership experience.
• Experience in CDMO or regulated manufacturing environments, 211 focus.
• Proven experience with FDA inspections and cGMP compliance.

Responsibilities

• Provide Quality and Regulatory governance for US facilities and programs under 21 CFR Parts 210 and 211.
• Lead and maintain the Quality Management System in line with FDA cGMP and USP standards.
• Escalate significant quality risks and authorize action to prevent compromised product quality.
• Establish readiness for new operations, tech transfers, and validation activities.
• Serve as primary FDA contact during regulatory inspections and client interactions.
• Oversee regulatory inspections, audit responses, CAPA, and root cause analyses.
• Drive continuous quality improvement and data-driven decision making.

Skills

Strategic leadership

FDA regulatory knowledge

Quality governance

Risk management

Multi-site oversight

Regulatory inspections

CAPA & investigations

QMS stewardship

Education

Bachelor's in Pharmacy/Related field

Advanced degree preferred (MS/PharmD/PhD)

Tools

QMS (Quality Management System)

CAPA process

Regulatory submissions

Job description

PharmaLogic is seeking a Director of 211 Manufacturing Quality & Regulatory to lead quality governance for US operations, facilities, and client programs subject to 21 CFR Parts 210 and 211. This role oversees the QMS, regulatory compliance, inspection readiness, and continuous improvement across radiopharmaceutical manufacturing.

The incumbent will guide quality leadership, ensure FDA readiness, manage multi-site quality oversight, and serve as the primary liaison during inspections and