Quality Operations Leader: Compliance & Validation

Pfizer Inc; Rochester (MN); On-site; USD 106,000 - 177,000; Full time

Benefits offered by this job

401(k) plan with Pfizer Matching Contr

Pfizer Retirement Savings Contribution

Paid vacation

Holiday and personal days

Paid caregiver/parental and medical le

Health benefits: medical, dental, vis

Job summary

Pfizer Inc. in Rochester, MN is seeking a senior quality leader to oversee Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, and Data Integrity within the Rochester Quality organization.

You will coach colleagues, drive audits, and ensure site readiness while managing budgets and resources. The role requires strong knowledge of cGMP, regulatory expectations, and leadership of multi-disciplinary teams.

Qualifications

• BA/BS with relevant experience in quality or manufacturing.
• Experience in cGMP regulatory environments and audits.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Lead Compliance, QA Documentation, Supplier Management teams.
• Oversee validation, sterility, data integrity programs.
• Drive site readiness and regulatory inspections readiness.

Skills

Leadership

Quality systems

Regulatory knowledge

Audits

Cross-functional collaboration

Education

BA/BS in a scientific/engineering field

MBA/MS in related field

PhD/JD (optional)

High School Diploma with 10+ years

Tools

MS Office

TrackWise

Project

Regulatory databases

Job description

Pfizer Inc. in Rochester, MN is seeking a senior quality leader to oversee Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, and Data Integrity within the Rochester Quality organization.

You will coach colleagues, drive audits, and ensure site readiness while managing budgets and resources. The role requires strong knowledge of cGMP, regulatory expectations, and leadership of multi-disciplinary teams.