Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveThis position will support the Pfizer Sanford North, NC Quality Assurance department by serving as the champion for the PGS site Data Integrity program; is assigned the oversight and sponsorship of the overall site approach and is actively engaged in strengthening the site data controls and individual accountability for the integrity of GMP data at the site through facilitation education, awareness and reporting. You will serve as the point of contact for center Data Integrity program office and is accountable to facilitate appropriate site-based initiatives to ensure effective rollout of Data Integrity program elements launched by center. Engaging, communicating, and influencing the site leadership team will be instrumental in achieving a quality culture aligned around the importance of achieving good data management practices. The emphasis of this role is sponsorship and assurance of adequate Data Integrity program actions and awareness.How You Will Achieve It
Develop, manage, and execute the site Data Integrity program at the site.
Work with site leadership and partner with Center colleagues to develop and maintain a robust site strategy, including action plans, to ensure data management practices are compliant with Pfizer and regulatory expectations.
Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department.
Drive effective management of quality issues and make decisions that may involve complex quality and technical issues.
Communicate with and influence internal and external customers across the site and department boundaries to ensure compliant and aligned resolution of project related issues.
Contribute to Quality Assurance by undertaking a variety of roles and assignments to further develop internal processes and people.
QualificationsMust-Have
Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an Associates Degree with 8 years of experience OR a Bachelors Degre with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
Relevant pharmaceutical experience (Quality Operations)
Demonstrated business acumen, experience in managing projects teams, programs, or workstreams of varying levels of complexity
Demonstrated knowledge and awareness of Data Integrity and potential impact on site operations
cGMP experience with compliance issues
Proactive approach and strong critical thinking skills
Project Manager, team leader/project leader or coach
Strong oral and written communication skills
Strong verbal and written English communications capabilities
Nice-to-Have
Demonstrated previous experience in problem solving, decision making, negotiating and conflict resolution skills
Capability in Lean tools and/or desire to grow Lean capabilities to further drive Continuous Improvement projects.
Functional knowledge of Microsoft SharePoint and Office applications, particularly Excel
Physical / Mental requirements
Must be able to stand or walk for an extended period of time.
Non-Standard work schedule, travel or environment requirements
Minimal travel
Role will require after hour and weekend support from time to time.
Other job details
Last day to apply: March 15th, 2024
Employee Referral Bonus eligible
Relocation support available
Work Location Assignment:FlexibleThe annual base salary for this position ranges from $93,500.00 to $155,900.00. 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 ActPfizer 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 EligibilityPfizer 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.Information & Business Tech#LI-PFE