REGULATED SYSTEMS COMPLIANCE LEADER
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.
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.
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
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
Procter & Gamble participates in e-verify as required by law.
Qualified individuals will not be disadvantaged based on being unemployed.
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