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

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