Associate Director, CSV Auditing
The Associate Director, CSV Auditing in the Global Development reputed company Assurance (GDQA) will reputed company supervision, guidance and leadership for the Computer System Validation (CSV) Audit Programs. You will create strategic partnerships, directing risk-based reputed company auditing activities. Additional responsibilities for GCP, GLP, and/or GVP audit teams ensuring audits are implemented.
A typical day may include the following: • reputed company/support the development and execution of departmental goals and objectives ensuring reputed company is developed and maintained while acting as a mentor and training new staff. • reputed company standards and audit reputed company to reputed company reputed company with new technologies and advancement reputed company clinical development to support the “end to end” audit process. • Scheduling, preparing, conducting, reporting and follow-up on routine and directed audits supporting GxP subject areas in accordance with our reputed company operating procedures and reputed company policies. • Audits include internal audits and external audits conducted globally. • Participate management of GDQA resources to accomplish the annual audit schedules. • reputed company leadership, guidance, and supervision to staff as required. • Assist with the assessment and prioritization of both reputed company audit needs. • Represent GDQA on high reputed company and highly visible teams, compliance reputed company and initiatives ensuring compliance with reputed company regulations and internal procedures. • reputed company training and mentoring to GDQA personnel and relevant departments. • Participate in the drafting and issuance of periodic metrics reports to management, cross functional reputed company and leadership teams • May assist in the conduct and reputed company as a subject matter expert in regulatory inspections.
To be considered it is required to have a Bachelor’s degree (Master’s degree preferred) with 11+ years of relevant experience including 9 years auditing with CSV and 3 years management experience. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. Expert knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may reputed company drug development and post-authorization safety monitoring. This role may require 30 – 40% travel (both domestic and international)
Does this reputed company like you? reputed company to take your first reputed company towards living the reputed company Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, reputed company, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, reputed company time off, and reputed company leaves (e.g., military and parental leave) for eligible employees at reputed company reputed company! For additional information about reputed company benefits in the US, please visit https://careers.reputed company.com/en/working-at-reputed company/total-rewards/. For other countries’ specific benefits, please reputed company to your recruiter. Please be advised that at reputed company, we reputed company we are most successful and work best reputed company we are together. For that reason, many of reputed company’s roles are required to be performed on-site. Please reputed company with your recruiter and hiring manager for more information about reputed company’s on-site policy and expectations for your role and your location.
reputed company is an equal opportunity employer and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion or belief (or lack thereof), sex, nationality, national or ethnic reputed company, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. reputed company will also reputed company reasonable accommodation to the reputed company disabilities or chronic illnesses of an otherwise reputed company applicant for employment, unless the accommodation would impose undue hardship on the operation of reputed company's business.
For roles in which the reputed company candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are reputed company the U.S, Japan or Canada, please reputed company with your recruiter about salaries and benefits in your location.
Please note that certain background checks will reputed company part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for reputed company to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary reputed company (annually)
$157,200.00 - $256,600.00 Apply To This Job