This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. AD, Quality & Compliance Lead based in United States.
This senior leadership role is responsible for driving quality and compliance excellence across the drug and device lifecycle within a highly regulated life sciences environment. You will act as a key expert in GxP quality systems, ensuring patient safety, data integrity, and regulatory compliance across clinical and development activities. The role plays a critical part in shaping and maintaining the Quality Management System while embedding a strong culture of quality across US operations. You will serve as a strategic advisor to cross-functional teams, supporting efficient drug development and regulatory readiness. With significant exposure to global and regional stakeholders, you will help translate global quality strategy into effective local execution. This position is both advisory and hands-on, combining governance, risk management, and inspection leadership responsibilities in a dynamic, science-driven organization.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. AD, Quality & Compliance Lead based in United States.
This senior leadership role is responsible for driving quality and compliance excellence across the drug and device lifecycle within a highly regulated life sciences environment. You will act as a key expert in GxP quality systems, ensuring patient safety, data integrity, and regulatory compliance across clinical and development activities. The role plays a critical part in shaping and maintaining the Quality Management System while embedding a strong culture of quality across US operations. You will serve as a strategic advisor to cross-functional teams, supporting efficient drug development and regulatory readiness. With significant exposure to global and regional stakeholders, you will help translate global quality strategy into effective local execution. This position is both advisory and hands-on, combining governance, risk management, and inspection leadership responsibilities in a dynamic, science-driven organization.
Accountabilities:
- Lead quality and compliance oversight across GCP/GVP activities, ensuring adherence to regulatory and internal quality standards throughout the product lifecycle
- Manage supplier quality processes including qualification, oversight, performance monitoring, and termination activities
- Serve as Quality and Compliance Lead on clinical or development projects, providing expert guidance on study-level quality requirements
- Drive development, maintenance, and continuous improvement of the Quality Management System, ensuring alignment with US regulatory requirements
- Lead and support FDA and regulatory authority inspections, including preparation, execution, response management, and follow-up activities
- Oversee audit activities, contribute to audit planning, and ensure findings are addressed with effective CAPA implementation
- Identify, assess, and mitigate quality risks, ensuring proactive issue management and continuous improvement of compliance processes
- Act as a key advisor to business and medicine functions, embedding Quality by Design principles across operations
- Lead non-compliance investigations, root cause analysis, and corrective and preventive action (CAPA) development
- Provide quality analytics, trend analysis, and recommendations to improve processes and decision-making
- Bachelor’s degree required; advanced degree (PharmD, PhD, or Master’s) preferred
- 8+ years of experience in GCP quality, clinical compliance, or related pharmaceutical development roles
- Proven experience in inspection management with FDA or other regulatory authorities (lead or support capacity)
- Strong knowledge of Quality Management Systems (QMS), GCP/GVP standards, and regulatory frameworks
- Deep understanding of drug development processes and Quality by Design (QbD) principles
- Experience managing audits, CAPA systems, supplier quality, and compliance risk management
- Strong leadership and communication skills with ability to influence across global and cross-functional teams
- Analytical mindset with ability to interpret data, identify trends, and support decision-making
- Experience in project or matrix leadership environments with strong organizational and problem-solving skills
- Ability to travel domestically and internationally as required
- Competitive base salary ranging from $170,000 to $269,000 depending on experience and qualifications
- Eligibility for discretionary bonus and additional compensation elements (including potential relocation support)
- Comprehensive medical, dental, and vision insurance coverage
- Retirement savings plans and financial wellness programs
- Generous paid time off and flexible work arrangements (where applicable)
- Career development, leadership training, and global mobility opportunities
- Exposure to global regulatory and scientific projects in a high-impact environment
- Professional growth within a leading, innovation-driven life sciences organization
In this role, you will lead and oversee quality and compliance activities across clinical development and supplier operations while ensuring alignment with global standards and regulatory expectations.
Requirements:
This role requires deep expertise in clinical quality systems, regulatory compliance, and strong leadership capabilities within a pharmaceutical or biotech environment.