Quality & Regulatory Lead

Job Title: Contractor Quality & Regulatory Lead (CQRL) Remote Duration: 15-Month Contract Work Hours: 8:00 AM – 5:00 PM (PT) Travel Requirement: This is a remote role with periodic on-site visits required across Southern California, including: • North San Diego region • Areas south and east of Oceanside • Santa Monica and areas north of Long Beach Role Overview We are seeking a Contractor Quality & Regulatory Lead (CQRL) to support a high-visibility, fast-paced project within a global pharmaceutical environment. This role will focus on onboarding new external contractors (CMOs) and ensuring quality, compliance, and regulatory readiness for commercial distribution. The CQRL will operate within a virtual global team structure (VSOT), partnering across regions including Ireland and the U.S., and acting as a key liaison between external manufacturing partners and internal regulatory/quality teams. Required Qualifications Experience • 10+ years in FDA-regulated pharmaceutical/biotech industry • Background in one or more: • Quality Assurance (QA) • Quality Control (QC) • Regulatory Affairs • Technical Services / Pharma Sciences • Strong experience in: • GMP environments • Change management & investigations • External manufacturing / CMO oversight Technical Expertise • Experience with: • Biologics and/or drug substance (API) manufacturing • Validation and technical document review • Regulatory submissions and lifecycle management • Familiarity with: • FDA, EMA, and global regulatory frameworks • Inspection readiness and compliance trends Tools & Systems • Hands-on experience with: • Veeva Vault • SAP • eQMS systems Key Responsibilities 1. Quality Oversight & Compliance • Oversee GMP-regulated manufacturing environments across multiple external sites. • Ensure compliance with FDA regulations, global cGMP, and GDP standards. • Review and assess: • Change controls • Deviations & investigations • Validation documentation • Product quality records • Support readiness for commercial distribution from a quality standpoint. • Participate in and support audits, inspections, and compliance assessments. 2. Change Management & Regulatory Impact • Evaluate change controls and perform regulatory impact assessments. • Collaborate with regulatory teams to determine post-approval change requirements. • Support: • Product Change Forms (PCFs) • Regulatory submissions and approvals • Health Authority (BoH/FDA) query responses • Track submission status, approvals, and implementation timelines. 3. External Partner & CMO Management • Manage quality and compliance activities for external suppliers and Contract Manufacturing Organizations (CMOs). • Support new contractor onboarding and site integration. • Act as the primary liaison between: • CMOs • Virtual Site Operating Teams (VSOTs) • Global Regulatory & CMC teams • Ensure alignment on quality agreements and regulatory expectations. 4. Technical Review & Validation • Provide technical quality review (not primary authoring) of: • Validation protocols/reports • Manufacturing and quality documentation • Ensure systems and processes meet regulatory and internal standards. • Support process readiness for biologics and API (drug substance) manufacturing. 5. Systems & Tools • Work within key quality and regulatory systems such as: • Veeva Vault • SAP • eQMS platforms • Maintain accurate documentation and tracking of quality/regulatory actions. 6. Cross-Functional Collaboration • Engage heavily with global, cross-functional teams in a virtual environment. • Support global projects with high visibility and accelerated timelines. • Communicate effectively across stakeholders and geographies. 7. Problem Solving & Continuous Improvement • Lead/support complex investigations, risk assessments, and complaint handling. • Apply science-based, risk-based decision making (QRM principles). • Drive process improvements in quality and regulatory workflows. • Operate effectively under high pressure and tight deadlines. Site Coverage Support multiple manufacturing sites across Southern California, including: • North San Diego region • Areas south/east of Oceanside • Region around Santa Monica and north of Long Beach Skills • Strong project management and organizational skills • Excellent communication and stakeholder management abilities • Ability to: • Work in high-pressure, fast-paced environments • Think critically and solve complex problems • Be agile and adaptable in evolving situations • Strong technical writing and review skills • Collaborative mindset with ability to work in global virtual teams Apply Now Apply Now