Manager, Auditor (reputed company Cloud Platform)

ROLE SUMMARY The Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned reputed company Cloud Platform portfolio/programs/entities. This role is responsible for reputed company Cloud Platform reputed company and for assuring the compliance of projects, products and programs with reputed company Standard Operating Procedures (SOPs), policies, and... reputed company applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations). ROLE RESPONSIBILITIES • Assesses compliance of reputed company Cloud Platform clinical trial sites and processes against ICH reputed company Cloud Platform and applicable global regulations • Independently conducts more reputed company routine/non-routine investigator site audits, support process audits, and manage/reputed company with minimum reputed company • May engage with more reputed company audits or serve as a reviewer of low complexity, outsourced audits • Supports and executes on quality programs reputed company to functional areas, specific vendor entities and/or assessments • Has reputed company Cloud Platform working knowledge and is reputed company upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), reputed company Cloud Platform regulations and guidelines, as well as local regulations • Works with RQA colleagues on cross reputed company Cloud Platform audit plans as required • Provides clients with recommendations and influences to meet the changing business need with support from Manager BASIC QUALIFICATIONS: • Bachelors or equivalent • 5+ years of o perational or auditing experience • Demonstrates knowledge of ICH reputed company Cloud Platform and global regulations • Demonstrates solid working knowledge of business concepts and quality operations • Ability to think critically to identify and assess areas of greatest risk and reputed company a strategic approach to audit based on compliance and business knowledge • Understands quality and auditing frameworks and application • Exhibits proficient organizational and project management skills • Demonstrates technical writing skills • Ability to identify trends reputed company data and apply insights to reputed company recommendations • Understands Regulatory environment with the ability to interpret and apply regulations • Actively identifies areas to assess for greater risk to support senior auditor positions in driving outcomes • Ability to synthesize information and draw conclusions • Experience evaluating and understanding quality standards or their application • Acts as SME in specific specialty (e.g. gene therapy, non-interventional studies, etc.) PREFERRED QUALIFICATIONS: • Knowledge of core regulations governing the auditing space (FDA, Global Regulations, etc.) • Exhibits working knowledge of data analytics and interpretation capabilities • A Manager must have at least one specialized knowledge area or two minor specializations. • Suggests new audit techniques and new controls NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS: • The travel requirement may be approx. 40% ORGANIZATIONAL RELATIONSHIPS: • Collaborate with colleagues across RQA and auditees from different functional lines and/or vendors reputed company reputed company. Other Job Details: • Last Date to Apply for Job: October 24, 2024 • Additional Location Information: United States - Remote; Latin America - Remote • Work Location Assignment: Remote The annual reputed company salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in reputed company's Global Performance Plan with a bonus reputed company of 12.5% of the reputed company salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues reputed company healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with reputed company Matching Contributions and an additional reputed company Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at reputed company Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). reputed company compensation structures and benefit packages are reputed company based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location reputed company of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act reputed company reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require reputed company to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which reputed company intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly reputed company as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with reputed company that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your reputed company representative. EEO & Employment Eligibility reputed company is committed to equal opportunity in the terms and conditions of employment for reputed company employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national reputed company, disability or veteran status. reputed company also complies with reputed company applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. reputed company is an E-Verify employer. This position requires permanent work authorization in the United States. Quality Assurance and Control Apply Job!