Senior Director, Quality & Compliance
WFA Digital Insight
The demand for quality and compliance experts in the pharmaceutical industry has surged in recent years, with a reported 25% increase in job openings. As a Senior Director of Quality & Compliance, you'll be at the forefront of ensuring clinical trials meet the highest standards of regulatory compliance. Precision Medicine Group, a leader in the field, is seeking a seasoned expert to drive its quality assurance programs. With the industry's growing focus on patient safety and data integrity, this role is ideal for those with a strong background in GCP and a passion for leading cross-functional teams. Before applying, candidates should be aware of the complexities of global regulatory requirements and the importance of strategic compliance guidance.
Job Description
About the Role
The Senior Director, Quality & Compliance plays a pivotal role in Precision Medicine Group's commitment to delivering high-quality services that adhere to global regulatory standards. This position entails providing strategic and operational leadership for clinical quality assurance, ensuring that studies are conducted, documented, and reported with the utmost integrity and compliance. As a key member of the management team, the Senior Director will partner with cross-functional stakeholders to identify and mitigate quality and compliance risks, driving a culture of quality and data integrity across the organization.The Senior Director will lead the design, implementation, and continuous improvement of GCP-focused quality systems and oversight activities. This includes the development of risk-based audit programs, issue management, and inspection readiness, as well as supporting health authority and sponsor audits/inspections. The ability to work collaboratively with Operations and other stakeholders is essential, as is the capacity to develop and mentor QA professionals.
Given the critical nature of this role, the Senior Director will be expected to maintain current knowledge of regulations and guidance documents, providing expert analysis to projects and contributing to the development of corporate quality initiatives.
What You Will Do
- Lead and maintain GCP quality assurance programs to ensure compliance with FDA, EMA, and ICH regulatory requirements
- Provide ICH/GCP compliance guidance throughout the clinical development life cycle
- Plan, oversee, and conduct GCP audits, including qualification and re-qualification of vendors, internal processes, site audits, and document audits
- Manage Quality and Compliance functional activities, including the implementation and management of the QMS, SOPs, training, and CAPAs
- Work closely with Quality and Compliance staff and Operational Functions to provide strategic compliance advice and guidance
- Initiate follow-up processes when suspicion of suspected scientific misconduct or serious non-compliance arises
- Review clinical and nonclinical documentation to ensure regulatory compliance, data integrity, and adherence to GCP standards
- Oversee quality events, deviations, and CAPA processes related to GCP activities
- Lead and support global health authority inspections
- Provide GCP guidance and training to cross-functional teams to promote a culture of quality and regulatory compliance
- Lead and develop Clinical QA staff while supporting continuous improvement of GCP and quality systems
What We Are Looking For
- Minimum of 10+ years of experience in GCP Quality Assurance within a CRO, biotechnology, or pharmaceutical industry
- Bachelor’s degree in life sciences or a related scientific field (advanced degree preferred)
- Demonstrated experience conducting and leading GCP audits across clinical sites and internal processes
- Strong knowledge of ICH E6 GCP, FDA regulations, and international quality standards
- Proven ability to lead and manage cross-functional teams
- Excellent communication and interpersonal skills
- Experience with quality management systems (QMS) and audit programs
- Familiarity with Adjust and Excel for data analysis and reporting
Nice to Have
- Experience with electronic data capture systems and clinical trial management systems
- Knowledge of regulatory requirements for drug and device development
- Certification in auditing or quality assurance (e.g., CQA, CIA)
- Experience working in a fast-paced environment with multiple projects and deadlines
Benefits and Perks
- Competitive salary
- Comprehensive health insurance
- Retirement savings plan
- Paid time off and holidays
- Flexible working hours and remote work options
- Professional development opportunities
- Access to cutting-edge technologies and tools
- Collaborative and dynamic work environment
- Recognition and reward programs for outstanding performance,
How to Stand Out
- Ensure your resume and cover letter highlight specific examples of GCP quality assurance experience and knowledge of regulatory requirements.
- Develop a strong understanding of the company's quality management systems and be prepared to discuss how you can contribute to their improvement.
- Showcase your ability to lead and manage cross-functional teams, including experience in mentoring and developing QA professionals.
- Be prepared to discuss your approach to risk-based audit programs and issue management, as well as your experience with inspection readiness.
- Consider obtaining certifications in auditing or quality assurance to enhance your application and demonstrate expertise.
- Research the company's current projects and initiatives to understand how your skills and experience align with their goals and objectives.
- Prepare thoughtful questions for the interviewer, such as the company's approach to quality and compliance, opportunities for professional development, and the team's dynamics.
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