Senior Quality Lead

The Opportunity

We are seeking an experienced Senior Quality Lead to join the Quality Assurance Programs team. You will bring diverse thinking and technical experience in various Quality disciplines (e.g., GCP, CSV, device). Note: This role requires strong level GCP knowledge and will be accountable for the quality assurance aspects and leading/supporting inspections of key molecules. CSV and device are preferred but not the main requirement.

Key Responsibilities

• Designs and delivers Quality Strategies and conclusions for assigned Molecules by applying a risk-based approach based on the Critical to Quality (CtQ) framework.
• Establish strong partnerships with business stakeholders and independently define the Quality Assurance approach, assessing specific risk areas and proposing strategy modifications.
• Define and Lead Audits: Define the audits required to deliver the Quality Assurance strategy and lead the development of methodology, including the use of data analytics. Independently perform and lead audits, managing preparation, conduct, presentation, timely reporting of outcomes, and evaluation of actions taken.
• Issue Management: Independently manage complex quality issues, group individual findings into systematic issues for process improvement, and escalate significant issues to PDQ management.
• Quality Conclusion and Stakeholder Communication: Independently draw conclusions on the Quality Positions and ensure appropriate action plans are developed to determine acceptability of evidence of compliance. Lead the presentation of observations and associated compliance risks to business stakeholders and Pharma representatives, including discussions with Legal and Regulatory Affairs.
• PDQ Goals and Initiatives: Contribute and participate in PDQ goals and initiatives to the execution and delivery of PDQ work and the development of PDQ processes.
• Health Authority Inspections: Lead and support regulatory authority inspections. Mentor and support the development of Quality Leads within the team.
• PDQ Leadership: Contribute to the long-term strategic direction of PDQ, lead departmental or cross-functional compliance projects, and lead the development/revision of PDQ processes and procedures (SOPs, Work Instructions).
• Expertise and Mentorship: Maintain expert knowledge of GCP/GVP regulations, company policies, and SOPs, assess the impact of new regulations, and act as a trainer and mentor for International and Senior Quality Leads.
• Networking: Maintain and influence partnerships with senior business stakeholders and PDQ domains. Facilitate cross-functional collaboration to ensure quality standards are met globally.

Who You Are

• Bachelor’s degree or equivalent in scientific or quality-related field. Advanced degree preferred.
• Demonstrated applied knowledge of clinical / pharmacovigilance / drug safety and regulatory requirements.
• Project management experience with proven leadership, mentoring and coaching; Demonstrated ability to effectively organize and execute tasks
• High degree of experience, competency, and proven track record leading multiple complex audit types in multiple GCP areas.
• Preferred Device / CSV experience
• Strong digital and data literacy
• Experience hosting, managing and/or supporting regulatory authority inspections; Ability to formulate clear business questions that can be answered with data and utilize data/visualization tools to generate insights.
• Proven ability to influence and negotiate effective solutions, drive change, and assimilate new compliance information/trends.
• Proven record of working in a global, multicultural matrixed organization (multi-lingual skills desirable).