Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
Job Description
DESCRIPTION:
Join our Compliance team and play a critical role in ensuring regulatory excellence and inspection readiness across our operations. As the Compliance Manager, you will lead initiatives that promote adherence to regulatory requirements, quality standards, and customer expectations while driving a strong culture of compliance throughout the organization.
This role is responsible for managing internal and external audits, coordinating regulatory and customer inspections, leading responses to audit observations, and ensuring timely implementation of corrective and preventive actions (CAPAs). Working closely with Quality, Operations, Regulatory Affairs, and cross-functional stakeholders, you will help maintain inspection readiness, identify compliance risks, and drive continuous improvement of quality systems and compliance processes.
Location: Middletown, VA
Relocation assistance is NOT provided.
REQUIREMENTS:
- Bachelor's degree in Life Sciences, Engineering, Quality, or a related discipline.
- 4+ years of experience in Quality, Compliance, or Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry preferred.
- Demonstrated experience managing internal audits, customer audits, regulatory inspections, and third-party audits.
- Lead cross-functional compliance initiatives and serve as the site compliance representative during regulatory inspections and customer audits.
- Strong knowledge of FDA regulations, GMP, ISO 13485, and other applicable quality and regulatory requirements.
- Experience coordinating responses to regulatory observations, audit findings, and CAPA activities.
- Proven ability to maintain inspection readiness and drive continuous compliance improvements.
- Experience interpreting regulatory requirements and translating them into effective quality and compliance practices.
- Strong project management skills with the ability to lead cross-functional initiatives.
- Experience analyzing compliance metrics and using data to identify trends and improvement opportunities.
- Proficiency with quality management systems and compliance software such as TrackWise and MasterControl.
- Excellent written and verbal communication, presentation, and stakeholder management skills.
- Demonstrated ability to influence across multiple organizational levels and foster a culture of quality and compliance.
- Strong analytical, organizational, and problem-solving skills with exceptional attention to detail.
- Must be legally authorized to work in the United Stateswithoutsponsorship.
- Must be able to pass a comprehensive background check, whichincludes a drug screening.
