Contractor Quality and Regulatory Lead, Senior Associate

job summary:
This role is for a Senior Associate (Contractor Quality & Compliance) supporting oversight of external Contract Manufacturing Organizations (CMOs). The individual will ensure product quality, regulatory compliance, and operational alignment between external partners and internal teams.

The position should be based in the United States, ideally in the Eastern Time Zone, to enable better collaboration with global stakeholders. The primary CMO supported is located in Canada, with additional interaction across global teams.

location: New York, New York
job type: Contract
salary: $45 - 47 per hour
work hours: 9 to 5
education: Masters


responsibilities:

• Quality & Compliance Oversight: Manage all aspects of product quality, compliance, and GDP oversight for a portfolio of external contract manufacturers (CMOs) and suppliers to ensure product specifications and global regulatory standards are met.
• Regulatory Expertise & Change Management: Act as the regulatory expert within the team; perform impact assessments for Post-Approval Changes (PAC), manage eQMS/change control records, and coordinate with Global CMC and country offices on regulatory strategies.
• Audit & Inspection Support: Lead and support internal/external partners during quality audits, compliance assessments, and regulatory inspections to ensure strict adherence to current GMP/GDP guidelines.
• Investigation & Risk Management: Own and drive complex quality investigations, market complaints, and risk assessments, actively contributing to Quality Review Teams (QRTs) and escalating critical issues appropriately.
• Dossier & Registration Coordination: Coordinate the collection of supporting documentation for initial registrations, renewals, product launches, and Board of Health (BOH) queries, maintaining seamless tracking of submission approvals and rejections.
• Stakeholder & Lifecycle Management: Partner with internal and external stakeholders to develop Quality Agreements, review APR/PQR reports, support new CMO onboarding, and identify continuous improvement initiatives for external supply quality processes.

qualifications:

• Minimally 5 years of experience in GXP setting and/or Regulatory Affairs role (Pertinent Master's degree required).
• Expertise in external suppliers/contractors, Change Management and Regulatory.
• Experience with relevant QTS & eQMS modules.
• QRM practitioner.
• Demonstrated technical know-how, knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry qualit y assurance practices.

#LI-CV1

skills: Good Documentation Practices (GDP), Post-Approval Change Management, Quality Management Systems (QMS)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.