Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.  

What You Will Achieve

In this role, you will:

Provide Quality support and oversight for early phase and Co-Development programs within PSSM.Work with Business Development and PSSM to provide a framework for support for alliance partnerships.  Development of Quality Assurance Agreements.Provide Quality oversight and expertise related to project work that may involve external vendor facilities or at PGS sites on behalf of PSSM for API and drug product.As needed, interface with the PSOQ Vendor QA group to ensure that work placed at external vendors is manufactured to the high GMP expectations of Pfizer.Depending on project demands, partner with a QA Associate to provide an interface between the project team and other functions within Quality Assurance and QSEO.Interface with colleagues providing QA oversight and support for internal API and DP manufacturing operations to ensure timely release of materialsDepending on project demands, support the release and disposition activities for clinical supplies manufactured in the Groton, CT  SDM manufacturing facility.As project work demands, lead investigations related to product/facility deviations and investigations including root cause analysis, and Pfizer Human Performance assessmentsUse risk-management tools to assess quality issues occurring during manufacturing/testing activities Work with PSSM, Global Clinical Supply, PGS and external manufacturing vendors to define and implement CAPA activities for investigations and follow-up trend analysisSupport PSSM and PGS colleagues in the development of procedures which increase efficiency and maintain high quality standards  Provide support to internal audits (e.g. RQA) & regulatory inspections (e.g. FDA, MHRA) when required. Leads and/or participates on limited duration teams, continuous improvement initiatives and special projects for PSOQ and PSSM.

Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications

Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management

Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills

Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues

Here Is What You Need (Minimum Requirements)

BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience

Substantial experience in pharmaceutical manufacturing and quality control

Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects

Knowledge of regulations related to vendor management programs and other industry quality systems

Strong critical thinking skills and a proactive approach

Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally

Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as EMD 365, Quality Tracking System Trackwise, eQMS and Documentum platforms

Bonus Points If You Have (Preferred Requirements)

Experience in Quality Systems in pharmaceutical, medical device, or combination product industry

Knowledge or exposure to data science

Strong leadership and team management skills

Ability to work under pressure and meet tight deadlines

Ability to influence and negotiate with stakeholders

Experience in conducting internal audits and supporting regulatory inspections

Aseptic experience

  
Work Location Assignment: Hybrid

The annual base salary for this position ranges from $112 700,00 to $187 800,00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15,0% 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.

Quality Assurance and Control