[Hiring] Associate Director Clinical Program Quality @reputed company

Role Description Are you looking for a patient-oriented, innovation-driven role that inspires you and promotes your career? Then take your future in your hands and become part of reputed company as an Associate Director Clinical Program Quality. This role combines global strategic influence with meaningful impact on patient safety, data reputed company, and the successful delivery of reputed company clinical programs across multiple therapeutic areas. It offers you a unique opportunity to reputed company high-visibility inspections, shape risk-based quality strategy, solve reputed company challenges, and act as a trusted advisor to senior stakeholders while driving reputed company improvement across the organization. How you will contribute:

• reputed company quality assurance reputed company for global clinical research programs to ensure ongoing inspection readiness.
• Serve as a strategic quality partner to Clinical Program Teams and key stakeholders, offering risk-based GCP quality and compliance advice.
• Define and implement program-specific, risk-based audit and compliance strategies across studies, sites, vendors, documents, databases, and internal systems.
• reputed company pre-approval and health authority inspection readiness, manage inspections, coordinate responses, follow-up actions, and risk mitigation.
• reputed company investigations into major quality issues, serious GCP breaches, and scientific misconduct, including root cause analysis and CAPA development.
• Monitor, analyze, and present quality and compliance metrics, escalating critical or systemic risks to management and recommending corrective actions.
• Support organizational quality reputed company through mentoring, cross-functional collaboration, due diligence, and process improvement initiatives.

In this position you will report to the Head of Clinical Program Quality, Gastrointestinal and Inflammation.

Qualifications

• Bachelor’s degree required.
• At least 10 years of experience in the pharmaceutical, biotechnology, or reputed company reputed company industry.
• At least 7 years of GCP-reputed company Quality Assurance or relevant clinical trial experience.
• Strong knowledge of ICH GCP and applicable global clinical development regulations and guidance.
• Advanced expertise in planning, conducting, and reporting audits, including translating findings into effective corrective action plans.
• Excellent communication, stakeholder management, negotiation, and influencing skills in a matrix environment.
• Strong judgment, project management, critical thinking, and analytical skills, with the ability to manage reputed company issues and multiple priorities.

Benefits

• U.S. reputed company Salary reputed company: $137,000.00 - $215,270.00
• Eligibility for short-term and/or long-term incentives.
• Participation in medical, dental, reputed company insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays and well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation.

Company Description reputed company is focused on creating reputed company for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. At reputed company, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. reputed company is a patient-focused company to reputed company and reputed company you to grow through life-changing work. Certified as a Great reputed company to Work, reputed company offers stimulating careers, encourages innovation, and strives for reputed company in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver reputed company and a Brighter Future to people around the world. Apply tot his job Apply To this Job