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Job Location

PHOENIX PLANT

Job Description

Are you passionate about ensuring that systems produce world-class quality products? We are seeking a dedicated CSV and Data Integrity Manager for our Phoenix Plant. In this pivotal role, you will be responsible for the development, implementation, monitoring, and improvement of our quality systems, particularly focusing on Computer System Validation (CSV) and Data Integrity, in compliance with FDA regulations for drug and dietary supplements products.

As part of our Quality Assurance (QA) team, you will have a direct impact on the integrity of our brands and help us uphold our Quality Promise: “Superior Quality that creates Trust, Delight, and Value”.

Key Responsibilities:

+ Develop and maintain a comprehensive Computer System Validation (CSV) Master Plan, ensuring alignment with CFR 211, CFR 111, and Part 11 compliance requirements.

+ Oversee the execution of the CSV Master Plan, managing timelines, resources, and deliverables, while escalating conflicts and prioritizing tasks as necessary.

+ Ensure data integrity throughout the manufacturing process, implementing robust controls to safeguard the quality and reliability of data used in production and compliance reporting.

+ Collaborate with cross-functional teams to ensure that quality standards are communicated effectively and consistently applied across all operations.

+ Support and prepare for internal and external GMP audits, ensuring all quality management systems are in compliance with regulatory requirements.

+ Write, update, and maintain Standard Operating Procedures (SOPs) related to CSV and Data Integrity processes.

+ Manage document databases to ensure proper documentation and traceability of all quality-related activities.

+ Train QA team members and operations personnel on standard methodologies for CSV and data integrity, fostering a culture of quality and compliance.

+ Perform other duties as assigned to support the overall goals of the Quality Department and plant operations.

Join Our Team: If you are ready to take on a challenging and rewarding role that is critical to ensuring our plant operates at the highest quality standards, we encourage you to apply for the CSV and Data Integrity Manager position. Together, we can make a difference in delivering quality products our consumers trust.

Application Process: Please submit your resume and a cover letter detailing your relevant experience and why you would be a great fit for this role. We look forward to hearing from you!

Job Qualifications

Required Skills:

+ Bachelor of Science in Chemical or Industrial Engineering, or a similar science degree.

+ Proven experience in Computer System Validation and Data Integrity in a compliant manufacturing environment.

+ Strong understanding of CFR 211, CFR 111, and Part 11 regulations.

+ Excellent leadership and organizational skills, with a track record of managing complex projects.

+ Ability to support external and internal GMP audits effectively.

Preferred Skills:

+ Experience in products regulated as drugs and dietary supplements.

+ Strong verbal and written communication skills, with the ability to convey complex information clearly and concisely.

+ Demonstrated collaboration skills, with the ability to work cross-functionally and influence stakeholders at all levels.

Compensation for roles at P&G varies depending on a wide array of non-discriminatory factors including but not limited to the specific office location, role, degree/credentials, relevant skills, and level of relevant experience. At P&G compensation decisions are dependent on the facts and circumstances of each case. Total rewards at P&G include salary + bonus (if applicable) + benefits. Your recruiter may be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the hiring process.

We are committed to providing equal opportunities in employment. We value diversity and do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Immigration Sponsorship is not available for this role. For more information regarding who is eligible for hire at P&G along with other work authorization FAQ’s, please click HERE (https://faq.pgwebtools.com/us-work-authorization-faqs/) .

Procter & Gamble participates in e-verify as required by law.

Qualified individuals will not be disadvantaged based on being unemployed.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job Schedule

Full time

Job Number

R000131337

Job Segmentation

Recent Grads/Entry Level (Job Segmentation)

Starting Pay / Salary Range

$85,000.00 - $115,000.00 / year