Director of Quality & Compliance Systems (GMP, Audits)

Jobgether; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

Jobgether, on behalf of a partner company, seeks a Director, Compliance & Quality Systems in the United States to own and advance a comprehensive QMS within a regulated laboratory environment. You will design, implement, and operate the QMS aligned with GMP requirements and client expectations, preparing for audits and inspections.

The role focuses on scaling quality programs across multiple sites, embedding quality into a software-driven lab platform, and leading a dedicated QA/compliance team

Qualifications

• Bachelor's degree in life sciences, chemistry, engineering, or related discipline.
• 10+ years of experience in quality assurance or compliance within a regulated laboratory, CDMO, or biopharmaceutical environment.
• At least 3 years of experience leading QA or QC teams.
• In-depth knowledge of GMP requirements, including 21 CFR Parts 210 and 211.
• Strong understanding of data integrity requirements and principles, including 21 CFR Part 11, EU Annex 11, and ALCOA+.
• Direct experience managing regulatory inspections and client audits, incl. preparing responses that address findings.
• Experience developing or managing internal audit programs, supplier quality programs, and GMP training programs.

Responsibilities

• Oversee the full quality and compliance framework ensuring processes are effective and scalable.
• Lead design, implementation, and ongoing management of the QMS with document control, CAPA, change control, and risk management.
• Monitor QMS execution across sites with quality metrics and internal audits.
• Ensure compliance with client quality requirements and quality agreements.
• Embed quality requirements within the software platform and laboratory workflows.
• Track regulatory developments and translate into actionable readiness plans.
• Own the internal audit program and lead client audits and regulatory inspections preparation.
• Manage supplier quality programs and quality agreements with key suppliers.
• Deliver GMP training across sites and develop the quality team.

Skills

Quality leadership

Regulatory compliance

GMP knowledge

Auditing

Data integrity

Supplier quality

Education

Bachelor's degree in life sciences / related field

Tools

GAMP 5 familiarity

Job description

Jobgether, on behalf of a partner company, seeks a Director, Compliance & Quality Systems in the United States to own and advance a comprehensive QMS within a regulated laboratory environment. You will design, implement, and operate the QMS aligned with GMP requirements and client expectations, preparing for audits and inspections.

The role focuses on scaling quality programs across multiple sites, embedding quality into a software-driven lab platform, and leading a dedicated QA/compliance team