Contractor Quality & Regulatory Specialist

Job Title: Contractor Quality & Regulatory Lead
Duration: 6 Months
Location: Remote
 
Position Summary
This role is for a Senior Associate supporting Contractor Quality & Compliance activities for external Contract Manufacturing Organizations (CMOs). The individual will be responsible for ensuring product quality, regulatory compliance, and operational coordination between CMOs and internal cross-functional teams in a global environment.
The position is based in the United States, preferably in the Eastern Time Zone, to support collaboration with Canadian and global stakeholders. The role requires strong experience in quality systems, compliance oversight, and regulatory coordination within a GxP environment.
 
Day-to-Day Responsibilities

• Oversee quality and compliance activities for assigned CMOs and external manufacturing partners
  Review and manage change controls between CMOs and internal teams
  Handle product complaints, including investigation coordination, review, and resolution support
  Review and manage deviations reported by CMOs
  Review and approve Annual Product Quality Reviews (APQR/PQR)
  Review stability protocols, reports, and associated quality data
  Act as a liaison between Regulatory teams and CMOs for documentation and compliance activities
  Support document requests including Certificates of Analysis (COA) and Certificates of Compliance (COC)
  Coordinate with internal regulatory teams and country offices to support regulatory submissions and product variations
  Monitor product quality performance and ensure compliance adherence across external partners
  Collaborate with global stakeholders across multiple time zones

 
Must-Have Qualifications & Skills

• Strong experience working in GxP environments, preferably GMP/GDP regulated settings
  Hands-on experience in quality assurance and compliance activities
  Experience managing change controls, deviations, and product complaint investigations
  Experience working with CMOs or external manufacturing organizations
  Knowledge of APQR/PQR processes, stability data review, and quality documentation
  Familiarity with regulatory processes, submissions, and compliance documentation
  Ability to coordinate cross-functional activities between Quality, Regulatory, and external partners
  Strong communication, stakeholder management, and organizational skills
  Ability to work independently in a fast-paced global environment
  Comfortable collaborating across multiple time zones

 
Interview Process

• 2 rounds of interviews

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $46.46/hr.