Sr. Compliance Specialist, Systems
Senior Compliance Specialist, Quality Systems
We're working with a pharmaceutical manufacturing organization looking to add a Senior Compliance Specialist, Quality Systems to a high-visibility Quality team.
This is an excellent opportunity for someone who enjoys owning projects, supporting regulatory inspections, improving quality systems, and partnering across multiple departments to drive compliance initiatives. This is not a manufacturing-floor QA role. The focus is quality systems, compliance, audits, inspections, and continuous improvement.
The team is looking for someone who can come in, learn the business, take ownership of key quality processes, and become a trusted quality resource across the organization.
Key Responsibilities:
- Support and maintain Quality Management System (QMS) activities
- Drive compliance initiatives and quality system improvements
- Support regulatory inspections and customer audits
- Participate in inspection readiness activities and remediation efforts
- Partner with cross-functional teams to ensure GMP compliance
- Assist with CAPAs, change controls, deviations, and quality system records as needed
- Analyze trends and identify opportunities for continuous improvement
- Lead and support quality-focused projects across multiple functional areas
- Serve as a subject matter resource for compliance and quality systems activities
Desired Background:
- 5+ years of Quality Assurance, Compliance, or Quality Systems experience within the pharmaceutical industry
- Strong understanding of cGMP regulations and quality systems
- Experience supporting FDA, customer, or regulatory inspections
- Background in audit management, inspection readiness, or compliance programs
- Experience working within electronic quality management systems (eQMS)
- Strong communication skills with the ability to influence across departments
- Self-starter who can manage multiple priorities and work independently
- Comfortable in a fast-paced, highly collaborative environment
Compensation & Schedule:
- Up to $118,000 base salary
- 10% annual bonus
- Full-time, onsite position
- Monday-Friday schedule
Please Note:
- No relocation assistance available
- No visa sponsorship available now or in the future
- Candidates must be authorized to work in the United States without sponsorship