Job Description
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