CMC Regulatory Quality Advisor

Role Summary

The CMC Regulatory Quality Advisor is the quality expert for their area of responsibility, providing guidance and implementing quality initiatives to strengthen the SEQS and integrate quality into business processes. The role includes leadership of two direct reports and direct quality support to Global Regulatory Affairs with a focus on the CMC function.

Responsibilities

• Familiar with regulations and guidelines, provide interpretation, input into quality systems, and define quality direction to comply with external and internal expectations.
• Design and implement the Quality System within the business area, delivering milestones.
• Ensure compliance and inspection readiness by guiding execution of regulations at local, regional, and global levels.
• Develop and implement the quality strategy for the portfolio and functions, conduct quality risk assessments, and develop a risk management plan.
• Perform ongoing risk assessment of the quality system and recommend robust corrective actions.
• Engage in proactive data analysis to identify issues, trends, and opportunities for continuous improvement.
• Manage CAPA; oversee deviation/change management, root cause investigation, and corrective/preventive actions.
• Report issues through Notification to Management (NTM) as appropriate.
• Contribute to GQAAC audit plans based on identified signals/risks/gaps.
• Define, execute, and document quality self-assessments and discuss outputs with business partners.
• Serve as Business Quality Assurance (BQA) for critical business systems; perform IT BQA responsibilities, review/approve IT system documents, and partner with IT on system initiatives.
• Provide quality consultation for SEQS components (e.g., clinical research development) involving interactions across the organization.

Inspection Readiness and Inspection Management

• Lead pre-inspection preparation with business partners.
• Educate internal and external customers on inspection management.
• Actively support regulatory inspections (PV, site, sponsor).
• Coordinate and manage audits/inspections, including backroom and front room support.
• Manage audit/inspection responses and tracking through resolution.
• Participate in lessons learned sessions regarding clinical trial site support during inspections.

Influence Quality Direction

• Direct quality direction for the supported area and ensure consistent practices.
• Provide technical and team leadership for quality initiatives across portfolios and projects; influence leadership to resolve complex issues.
• Lead delivery of innovative solutions and prevent recurrence of issues.
• Support change management and business transformation in delivering critical priorities.

Problem Solving

• Lead teams in resolving issues, manage escalations, and coordinate interfaces to ensure resolution.
• Raise issues to management with well-thought-out solutions and action plans.

Quality Technical Leadership

• Provide data to senior management to drive decision-making (compliance, risks, issues).
• Initiate and coordinate quality improvement initiatives across affiliates/sites/functions.
• Develop quality agreements and advise on steps to ensure quality in partnerships and programs.
• Harmonize best practices across regions and other Quality organizations; recommend key projects.

Project Management

• Engage cross-functional and cross-geographical teams to deliver projects; optimize resource assignment.
• Use Six Sigma methodology to achieve project results; create simple, workable solutions to business problems.

Customer/External Focus

• Set quality expectations for third-party partners and advise on requirements and inspection needs.
• Act as quality consultant to business and external parties; build relationships with internal and external customers.
• Manage audits and regulatory inspections across regions and external partners.

Qualifications

• Bachelor‚Äôs Degree; preferred in science, technology, or medically related field
• Minimum 5 years‚Äô experience in the pharmaceutical industry, preferably in a CMC regulatory-related role

Other Information/Additional Preferences

• Extensive knowledge of GxP regulations, guidelines, and standards
• Project management experience
• Comfortable with new and developing technologies
• Excellent written and verbal communication, interpersonal, organizational, and negotiation skills
• Global perspective and ability to work across functional and geographical boundaries
• Knowledge of the international regulatory framework
• Ability to identify root causes and manage difficult global business/quality issues
• Ability to work effectively at all levels of the organization
• Excellent problem-solving skills and initiative
• Proficient English (written and spoken)
• Solid understanding of quality systems and CMC business processes
• Previous supervisory experience