The Root Cause Analysis Specialist will be responsible to:

Lead the investigation/root cause analysis, corrective/preventive action (CAPA) plan development for assigned cases

Support implementation of assigned plan components and tracking of actions to completion as necessary

Ensure documentation of root cause analysis and CAPA plan are accurate, complete and inspection ready

Root Cause Analysis/Due Diligence

This individual will also be required to apply a root cause methodology and/or due diligence approach to the case. This individual may either lead Quality Event (QE) cases from start to finish or be brought in conduct just the RCA portion of the investigation for systemic issues, process related issue or business critical cases.

Training

This individual will also be required to train new Investigation Case Leads in the Root Cause Analysis Methodology and provide mentoring to new Investigation Case Leads while they obtain RCA Certification.

The RCA Specialist will also be a subject matter expert in the Pfizer Human Performance (PHP) methodology and will be a resource to case leads to implement PHP in the investigation process and help teams error proof the process in question.

CAPA Plan Development and Management

Based on identified root causes, the individual will guide the SQE team in identifying appropriate corrective and preventive actions and conducting effectiveness checks on implemented actions to ensure they are working as expected.

Leverage process improvement best practice techniques (i.e., Six Sigma, Lean, etc.); analyze and optimize current business processes and develop and implement new business processes.

This individual will hold accountability for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected—for quality events, inspections and audits

Ensure implementation of QE / audit / inspection CAPAs and remediation plans Track effectiveness checks and report on trends.

Qualifications

BS – 10+ years or equivalent MS/MBA – 9+ years or equivalent

Previous Experience:

Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory

Regulatory inspection experience

Process and system management experience

Detailed knowledge of clinical trial processes and relationships required

Knowledge of GCP requirements and applicable SOPs and regulations

Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills

Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred

Previous Experience in conducting Root Cause Analysis, Error Proofing/Mistake Proofing and familiar with Pfizer Human Performance (PHP) and help analyze trends in data to identify potential investigations to address systemic process issues or program/protocol level issues.

This role will involve working with Vendor Quality and Clinical Quality colleagues.

Work with Vendor Quality and Clinical Quality groups to assist in developing investigation strategies related to vendor issues and program level quality issues.

Experience in leading process improvement efforts from inception to execution.

  
Work Location Assignment: Hybrid/Site Based

The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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 review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer 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 Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all 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.  Pfizer is an E-Verify employer.  This position requires permanent work authorization in the United States.

Medical

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