Contractor Quality & Regulatory Lead

Job Title: Contractor Quality & Regulatory Lead (CQRL)RemoteDuration: 15-Month ContractWork Hours: 8:00 AM – 5:00 PM (PT)Position Summary• Serve as a key member of ESOQ Tier 2 structure ensuring external suppliers/CMOs deliver high-quality, compliant products on time.• Act as the primary liaison between site, Global Regulatory Science (GRS), and external partners for regulatory and quality alignment.• Lead KPI-driven quality oversight, regulatory strategy, and change management across a portfolio of contract manufacturers.• Drive compliance with global GMP/GDP standards while enabling efficient regulatory submissions and product lifecycle management.Responsibilities• Manage all quality and compliance aspects for a portfolio of external suppliers and CMOs supplying materials/products.• Provide Quality Leadership within VSOT, advising on regulatory strategy, risks, and supply constraints.• Assess external supplier quality systems, processes, and documentation to ensure adherence to product specifications and regulatory standards.• Support internal and external audits including RQA audits and regulatory inspections.• Perform Compliance Assessments to ensure adherence to GMP/GDP and internal standards.• Support onboarding of new CMOs and product launches within the portfolio.• Make quality decisions using expertise in quality systems, manufacturing, and regulatory principles.• Influence quality decision-making aligned with industry regulations and internal requirements.• Develop, review, and negotiate Quality Agreements with CMOs.• Review and approve APR/PQR reports and stability data.• Support product endorsement, post-approval changes, registrations, and renewals.• Conduct regulatory impact assessments for changes affecting ESOQ-managed CMOs.• Own and manage change control processes to ensure timely execution and compliance.• Act as liaison between CMOs, VSOTs, Global CMC teams, Regulatory Strategists, and country offices.• Initiate and manage change management records in eQMS and Product Change Forms (PCF).• Coordinate collection of regulatory documentation for submissions, renewals, and queries.• Track regulatory submissions, approvals, commitments, and BOH queries.• Provide regulatory expertise utilizing systems such as RRM, PEARL, GDMS.• Support dossier compliance and implementation of new regulatory requirements.• Contribute to QRTs, investigations, and resolution of regulatory discrepancies.• Lead and support investigations, market complaints, and risk assessments.• Ensure GDP oversight in collaboration with Global Logistics and Network Services.• Drive continuous improvement initiatives across ESOQ processes.• Maintain accurate documentation and ensure escalation of compliance risks.• Build and maintain strong relationships with internal and external stakeholders.Regulatory Change Management• Perform regulatory impact assessments comparing current registrations with proposed changes.• Evaluate global regulatory requirements and guidelines using tools such as RRM.• Estimate BOH approval timelines and align with Global CMC and stakeholders.• Support deployment and maintenance of Common Technical Dossier (CTD/P-CTD).• Coordinate regulatory documentation collection for change control and submissions.• Raise and manage Product Change Forms (PCF) in PDM systems.• Facilitate Market Impact Assessments and communicate outcomes to stakeholders.• Track submission status, approvals, and regulatory queries.• Support responses to BOH queries and ensure timely documentation submission.• Communicate regulatory approvals, commitments, and implementation timelines.• Escalate critical quality or compliance risks as per SOPs.• Support license renewals, product registrations, site transfers, and product launches.QualificationsEducation:• Bachelor's degree in Life Sciences, Pharmacy, or related field (or equivalent experience).Experience:• Minimum 10 years of experience in GxP environment and/or Regulatory Affairs role.• Extensive experience with external suppliers, CMOs, and contract manufacturing oversight.• Proven experience in regulatory change management and compliance activities.Skills:• Strong expertise in GMP, GDP, global regulatory requirements, and inspection readiness.• Experience with QTS and eQMS systems and modules.• QRM practitioner with risk-based decision-making approach.• Strong project management and leadership skills with experience managing global projects.• Excellent communication, stakeholder management, and influencing skills.• Proficiency in regulatory systems such as RRM, PEARL, GDMS, and PDM.• Strong technical writing, documentation, and presentation skills.• Ability to manage complex investigations, compliance issues, and cross-functional initiatives.• Demonstrated ability to work independently and drive results.