Site Data Integrity Lead

Use Your Power for Purpose

Experienced Quality / data integrity professional responsible for the development, delivery, assessment and maintenance of the site Data Integrity program

Works effectively as a member of the Quality System team as well as directly with site personnel, site Management, site Leadership, and Corporate SMEs to support Data Integrity initiatives

What You Will Achieve

In this role, you will:

• Working with the Kalamazoo Leadership Team to provide leadership for good data management practices, processes, communications and culture for GMP activities.

• Establishing a data management governance process

• Engaging Corporate DI subject matter experts as needed

• Reporting good data management challenges and requirements to site leadership

• Ensuring referable compliance issues related to DI are reported to Corporate Compliance

• Participating in site inspection readiness activities

• Ensuring site Training Curricula include training for good data management practices

• Engaging in network forums for good data management, including sharing of best practices, challenges and solution-based ideas

• Deliver / Facilitate training directly related to data integrity as needed

• Conduct and report assigned internal audits (QASAs) for training in coordination with Audits and Inspections team

• Serve as Data Integrity Lead / SME during customer and regulatory audits and prepare requested documentation for review

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experienceStrong leadership and influencing capabilities across all organizational levels

• Experience with equipment operation and/or qualification activities and related data integrity reviews

• Demonstrated presentation skills to customers at various levels, with good written and verbal communication skills

• Candidate is required to have a sound understanding of GMPs and various types of validation and data integrity documentation (e.g. SOPs, User Guides, IQ/OQ, risk assessment)

• Clear track record of effective teamwork, collaboration and communication, with demonstrated ability to work in a cross-functional team environment

• Strong organizational and prioritization skills to handle multiple items with changing deadlines

• Strong critical thinking and analytical skills with high attention to detail

• Ability to manage change and deal with ambiguity

• Proficiency with Microsoft Outlook, Excel, PowerPoint

Bonus Points If You Have (Preferred Requirements)

• Demonstrated use of Data Integrity principles and concepts

• Familiarity with PDOCS for document storage and eQMS for change management is preferred

Work Location Assignment: On Premise

The annual base salary for this position ranges from $96,300.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base 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 lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer 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 Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer 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 Pfizer 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