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Sr. Associate, Contractor Quality Regulatory Lead
Job Location:
Job Location:
Andover, KS - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
20 May 2026 (30+ days ago)
Posted:
Application Deadline:
17 August 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Position Details:
Our client a world-leading Pharmaceutical Company is currently looking for a Supplier Quality Engineer to join their expanding team.
Our client a world-leading Pharmaceutical Company is currently looking for a Supplier Quality Engineer to join their expanding team.
Job Title: Supplier Quality Engineer / Pharma External Manufacturing / Remote Work
Duration: 6 months contract extendable up to 48 months
Location: Remote Worker
Duration: 6 months contract extendable up to 48 months
Location: Remote Worker
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Sr. Associate Contractor Quality Regulatory Lead
Summary:
The Contractor Quality & Regulatory Lead (CQRL) supports Pfizers external supply network by ensuring Contract Manufacturing Organizations (CMOs) and suppliers consistently deliver high-quality products in compliance with global GMP/GDP regulations internal quality standards and applicable regulatory requirements.
This role serves as the key liaison between external manufacturing partners and Pfizer internal teams including Global Regulatory Science (GRS) Global CMC and Virtual Site Operating Teams (VSOT). The CQRL is responsible for managing quality oversight activities driving regulatory change management and ensuring compliant execution of product lifecycle activities across a portfolio of outsourced products.
The Contractor Quality & Regulatory Lead (CQRL) supports Pfizers external supply network by ensuring Contract Manufacturing Organizations (CMOs) and suppliers consistently deliver high-quality products in compliance with global GMP/GDP regulations internal quality standards and applicable regulatory requirements.
This role serves as the key liaison between external manufacturing partners and Pfizer internal teams including Global Regulatory Science (GRS) Global CMC and Virtual Site Operating Teams (VSOT). The CQRL is responsible for managing quality oversight activities driving regulatory change management and ensuring compliant execution of product lifecycle activities across a portfolio of outsourced products.
Job Responsibilities:
Provide end-to-end quality oversight for external CMOs and suppliers ensuring compliance with GMP/GDP requirements.
Lead and support change control processes including regulatory impact assessments and Post Approval Changes (PACs).
Partner with regulatory and CMC teams to determine regulatory filing requirements submission strategies and implementation timelines.
Review and approve key quality documentation including Annual/ Product Quality Reviews (APR/PQR) stability reports and change control records.
Support audits regulatory inspections compliance assessments and complex quality investigations.
Manage quality agreements and support onboarding product launches site transfers and lifecycle changes for external manufacturers.
Track escalate and resolve quality and regulatory issues ensuring timely execution and compliance across global stakeholders.
Ensure accurate documentation and system updates within eQMS and related quality/regulatory systems.
Provide end-to-end quality oversight for external CMOs and suppliers ensuring compliance with GMP/GDP requirements.
Lead and support change control processes including regulatory impact assessments and Post Approval Changes (PACs).
Partner with regulatory and CMC teams to determine regulatory filing requirements submission strategies and implementation timelines.
Review and approve key quality documentation including Annual/ Product Quality Reviews (APR/PQR) stability reports and change control records.
Support audits regulatory inspections compliance assessments and complex quality investigations.
Manage quality agreements and support onboarding product launches site transfers and lifecycle changes for external manufacturers.
Track escalate and resolve quality and regulatory issues ensuring timely execution and compliance across global stakeholders.
Ensure accurate documentation and system updates within eQMS and related quality/regulatory systems.
Skills:
Minimum 5 years of experience in a GMP-regulated pharmaceutical or biotech environment.
Strong background in Quality Assurance Regulatory Affairs or CMC / Technical Operations.
Experience working with external suppliers CMOs or contract manufacturing networks.
Solid understanding of GMP/GDP regulations and global regulatory frameworks.
Experience with change control regulatory impact assessments and quality system management.
Familiarity with quality systems (eQMS) and regulatory documentation processes preferred.
Strong communication stakeholder management and cross-functional collaboration skills.
Ability to work independently in a global matrixed environment.
Minimum 5 years of experience in a GMP-regulated pharmaceutical or biotech environment.
Strong background in Quality Assurance Regulatory Affairs or CMC / Technical Operations.
Experience working with external suppliers CMOs or contract manufacturing networks.
Solid understanding of GMP/GDP regulations and global regulatory frameworks.
Experience with change control regulatory impact assessments and quality system management.
Familiarity with quality systems (eQMS) and regulatory documentation processes preferred.
Strong communication stakeholder management and cross-functional collaboration skills.
Ability to work independently in a global matrixed environment.
