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Job Details


Company name
Procter & Gamble.

Cincinnati, OH

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Do you have experience in regulated computer system validation, because we are looking for you. This position will be located at our Mason

Business Center in Mason, OH (suburb of Cincinnati, OH). You’ll work closely with our Quality Services and Corporate Quality Assurance

departments to ensure regulatory compliance of our computer systems. *OUR IT* IT is where business, innovation and technology integrate to build a daring advantage for us. Our mission is clear -- we deliver IT to help

win with consumers. As a professional, you are a diverse business leader who applies IT mastery to deliver groundbreaking business models and

capabilities. Whether your role is to build an innovation strategy for a business, protect our critical information systems and assets, or lead

a strategic supplier, your technical deep understanding will be recognized and rewarded. Your real passion for the industry will be further

nurtured by our culture of continued learning and growth. Your career builds change in leadership and influence skills, breadth of experience

across multiple businesses, and expertise in areas like Application & Integration, Infrastructure, Data & Analytics, and Security & Risk. *SO WHAT IS THE ROLE?* As the LEADER you will support the internal and external employees to validate our regulated computer systems while validating standard

operating procedure and templates. On a day-to-day basis you can expect to: - You will craft and maintain a Center of Expertise in computer system validation. - Proactively maintain in-depth knowledge of regulatory requirements for validated computer systems. - Own the definition of validation for project teams, validation teams, and support teams. - Monitor compliance of computer systems. - Lead in the compliance of electronic records and electronic signatures - Conduct reviews in accordance with good validation practices regulations and guidelines, existing SOPs, and system lifecycle criteria for

regulated computerized systems in manufacturing, laboratory and clinical areas - Develop and deliver training in support of the above responsibilities as necessary. *SO WHO IS THE IDEAL CANDIDATE?* You have demonstrably strong skills and high aptitude for learning new skills and work processes. You are focused in your execution and

comfortable performing tasks with minimal mentorship. You’re a go-getter with phenomenal communication skills. We’ll help you get up to speed

with extensive training with our digital tools and we’ll onboard you into the dynamic work environment of validation at our regulated sites.

As part of your startup you’ll learn about how we conduct risk assessments, when to audit software vendors, and who are our internal contacts. *THE REQUIREMENTS* Preferred: - At least 10 years’ experience in regulated computer system validation (e.g., Pharma, Medical Devices OTC drugs, CRO’s, etc.) - Can apply GMPs, GLPs, and GLPs to computer systems - Can evaluate computer systems for Part 11 and Annex 11 compliance, including electronic and digital signatures - Familiar with GAMP5 - Understands the benefits a controlled system development lifecycle - Active in Society of Quality Assurance’s Computer Validation Information Technology specialty section, Research Quality Assurance’s DIGIT

(Digital Information, governance, information technology) committee, or Drug Information Association’s Information Quality, Compliance &

Technology community, or a similar professional

organization has an active committee on computer system validation - Experience in quality management system tools, electronic testing tools - Strong verbal and written communication skills - Ability to work independently with minimal oversight - Can quickly learn digital tools such as ALM, and Veeva *Required:* - College degree in the Life Sciences, Computer Sciences, or Engineering - Experience in the preparation, execution, and

planning of software vendor, data center, and cloud service provider audits and assessments. - All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin,

protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship, HIV/AIDS

status or any other legally protected factor. - No immigration sponsorship is available for this position. P&G does not sponsor candidates for permanent residency except in some areas that in Procter & Gamble's sole discretion require highly

specialized backgrounds. - Procter & Gamble participates in e-verify as required by law. - Qualified individuals will not be disadvantaged based on being unemployed. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship, HIV/AIDS status or any other legally protected factor. Immigration sponsorship is not available for this position. Applicants for U.S. based positions are generally required to be eligible to work in the U.S. without the need for current or future sponsorship. Except in rare situations based on Procter & Gamble's sole discretion. Procter & Gamble does not sponsor candidates for permanent residency. Any exceptions would be based on the Company's specific business needs at the time and place of recruitment as well as the particular qualifications of the individual. Procter & Gamble participates in e-verify as required by law. Qualified individuals will not be disadvantaged based on being unemployed. **Job:** *Information Technology* **Title:** *REGULATED SYSTEMS COMPLIANCE LEADER* **Location:** *Ohio-Cincinnati* **Requisition ID:** *IT 00001342*

Company info

Procter & Gamble.
Website :

Company Profile
The Procter & Gamble Company, together with its subsidiaries, manufactures and sells branded consumer packaged goods. The company operates through five segments: Beauty, Grooming, Health Care, Fabric Care and Home Care, and Baby Care and Family Care. The Beauty segment offers antiperspirants and deodorants, cosmetics, personal cleansing, skin care, hair care, hair colors, prestige products, and professional salon products under the Head & Shoulders, Olay, Pantene, SK-II, and Wella brand names. The Grooming segment provides blades and razors, pre- and post-shave products, and electronic hair removal devices under the Braun, Fusion, Gillette, Mach3, and Prestobarba brand names.The Baby Care and Family Care segment offers baby wipes, diapers, pants, paper towels, tissues, and toilet papers under the Bounty, Charmin, and Pampers brand names. The company markets its products through mass merchandisers, grocery stores, membership club stores, drug stores, department stores, salons, high-frequency stores, and e-commerce in approximately 180 countries worldwide. The Procter & Gamble Company was founded in 1837 and is based in Cincinnati, Ohio.

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