Testing Contractor Quality Lead

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 be Responsible for:

Managing all aspects related to product quality or compliance for a portfolio of external contract manufacturers (CMO) contract testing organizations (CTO) and suppliers based in Europe and North America that supply materials/product(s)/service(s) to Pfizer according to established procedures.

Assess the quality of external suppliers products testing processes and related documents while ensuring the product specifications are met and quality systems are maintained.

Monitor quality performance and assess contractor quality culture.

Quality agreement negotiation execution and oversight.

Quality oversight at the CTO.

Creation of Process Orders (POs)s and support to define provisions within the SOW/MSA for QC testing execution at the CTO.

Audit coordination

Supporting internal and external partners with auditing activities related to ESOQ activities or activities at a portfolio of contractors - (RQA audits or Regulatory Inspections) as applicable

Supporting internal and external partners with Compliance Assessments to ensure current GMP adherence

Supporting onboarding activities of new CMOs CTOs or product launches within the portfolio as applicable.

Ensure stability studies at CMO/CTL sites are conducted according to approved protocols and ICH guidance.

Serve as stability SME for investigations and stability administration document approvals.

Manage all required activities to support external testing of stability studies.

Trend stability results to support product expiry and expiry extensions.

Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.

Influence quality decision making in line with industry and Pfizer requirements

Provide Quality Leadership within the cross functional virtual site operating teams (VSOT).

Partner with colleagues to develop and negotiate quality agreements.

Collaborate to ensure on time disposition of Product.

May identify develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.

Ensuring the adequate tracking and documentation of all required quality related actions in the relevant system(s) and ensuring that all required escalation processes are followed.

Leading and supporting investigations market complaints risk assessments in support of products within your portfolio. Connect with SMEs where needed.

Working independently receiving instructions primarily on unusual or complex problems.

Building maintaining and developing relationships with key stakeholders both internal and external to Pfizer.

Supporting ESOQ leadership on other tasks as required.

Here Is What You Need (Minimum Requirements)

Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of
relevant experience.

Advanced computer skills for MS Office and good knowledge of enterprise systems such SAP QTS Vault PDM Documentum platforms

Proficient in English (written and spoken)

Strong technical writing skills

Strong verbal written communication and presentation skills

Demonstrated personal leadership to work in virtual teams and in cross functional projects/initiatives

Demonstrated experience managing complex quality and compliance activities

Problem solving attitude and open to innovation

Demonstrated managerial/organizational skills

Takes initiatives and is proactive persistent

Good organizing and planning skills and a high sense of urgency

Demonstrated ability to act and work independently and to report items as required to line manager

Demonstrated knowledge of US European and global cGMPs compliance issues inspectional trends industry quality assurance practices

Demonstrated technical know how

Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives.

Bonus Points If You Have (Preferred Requirements)

Demonstrated experience in pharmaceutical manufacturing and testing activities (DP Biotech Oral Solid Dosage Aseptic) applicable to the role

Experience with external suppliers/contractors and contract testing lab including stability studies managment

Experience on managing investigations (DMAIC 6sigma ...)

Candidate demonstrates the ability to influence and collaborate with peers

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Up to 20% travel

Work Location Assignment:

Possibly based on North America East coast to be able meeting European Sites working schedule.

PHYSICAL/MENTAL REQUIREMENTS

The job performance may include lifting sitting standing walking bending ability to perform mathematical and statistical calculations and ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Up to 20% travel may be required.

Work Location Assignment:On Premise

Last Day to Apply: June 122025

The annual base salary for this position ranges from $96300.00 to $160500.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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.

Quality Assurance and Control