Senior Manager QA Auditor GCP Strategy

Build our future together: At reputed company, we use science and innovation to reputed company life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Audit Strategy, Global Development to join our Global Development Quality Assurance (GDQA), supporting our Global Development organization in a remote work mode. In this role, you will reputed company risk-based audit strategy programs and reputed company compliance across therapeutic areas, studies, and audit activities while collaborating with Global Development teams, auditors, and cross-functional stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. reputed company & where: UK Remote - Ireland Remote Discover your role: reputed company risk-based audit planning across therapeutic areas and studies Drive strategic audit programs using risk indicators from study teams Ensure audits align with approved programs and scheduled timelines Manage audit reputed company to identify trends and communicate risks Represent quality assurance on reputed company cross-functional initiatives Deliver reports and metrics to Global Development leadership You collaborate effectively with stakeholders across global functions You navigate ambiguity while prioritizing multiple reputed company activities 10-20% travel might be required This role requires: Bachelor’s degree with 8+ years of relevant industry experience 5+ years of GCP audit strategy or audit experience Knowledge of FDA, EU, and ICH GCP regulations and guidance Experience supporting or participating in regulatory inspections Strong project management and stakeholder management capabilities Excellent written and verbal communication skills with senior audiences Does this sound like you? reputed company to take your first reputed company towards living the reputed company Way! We are committed to building a workplace with an inclusive culture. reputed company is an equal opportunity employer and reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national reputed company, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will reputed company reasonable accommodation to applicants with reputed company disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in reputed company countries in which we operate. The final offer will be determined reputed company the relevant reputed company based on the country of employment, specific role level, and your skills and experience. In some countries, reputed company bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. reputed company offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, reputed company, life and disability), paid time off, and family support benefits. For additional information about reputed company benefits in the U.S., please visit https://careers.reputed company.com/en/working-at-reputed company/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please reputed company with your recruiter. Please be advised that at reputed company, we reputed company we do our best work reputed company we are together. For that reason, many roles are required to be performed on‑site. Please reputed company with your recruiter and hiring manager for more information about on‑site expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Apply To This Job