Senior Quality Assurance Compliance Specialist

Regulatory Jobs; Rochester (MI); On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) plan with Pfizer Matching Con‑

Paid vacation, holiday and personal

Health benefits to include medical, Rx

Relocation assistance may be available

Job summary

Pfizer is seeking a Quality Systems professional in the United States to evaluate CAPA responses, maintain QA policies, and support regulatory inspections, internal audits, and supplier assessments, ensuring timely action and compliance.

You will investigate customer complaints, collaborate with manufacturing sites and partners, analyze data, and drive continuous improvement while upholding cGMP, data integrity, and regulatory expectations.

Qualifications

• Quality investigations related to pharmaceutical or medical device manufacturing processes.
• Understanding of Quality System functions, manufacturing and packaging processes, validations, drawings, and basic statistics.
• Ability to apply statistics to Quality Engineering tasks.
• Excellent technical writing, communication, and presentation skills.
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software.
• Experience in preparing and participating in audits and inspections.

Responsibilities

• Evaluate CAPA responses for adequacy, effectiveness, and timeliness.
• Ensure QA policies and records remain compliant with regulatory requirements.
• Prepare for regulatory inspections and audits; develop and close action plans.
• Manage and document customer quality complaints; root cause analysis.
• Collaborate with internal stakeholders to complete investigations and records.
• Support Supplier Quality Management program.
• Assist with technical investigations and testing protocols.
• Collect and analyze quality data to identify improvement opportunities.
• Review quality system documentation and metrics; identify issues.
• Promote cGMP compliance and data integrity.
• Support investigations, deviation/change management, and continuous improvement.
• Prepare reports and quality metrics for management.

Skills

Quality investigations

Audits

Statistical analysis

Technical writing

Communication skills

Education

High school diploma with 8+ years

Associate’s degree with 6+ years

BA/BS with 2+ years

MBA/MS with any years

Tools

Microsoft Office

Microsoft Project

Statistical Software

Job description

Use Your Power for Purpose

Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.

What You Will Achieve

• Evaluate corrective and preventive action (CAPA) responses to internal and external audit observations for adequacy, effectiveness, and timely completion.
• Ensure Quality Assurance policies, procedures, and quality system records remain current and compliant with applicable regulatory requirements, corporate quality requirements, and site procedures.
• Prepare for and support regulatory inspections, internal audits, supplier audits, and quality assessments, ensuring timely development, implementation, and closure of resulting action plans.
• Manage, investigate, and document customer quality complaints for commercial drug products within the global complaints management system, ensuring thorough root cause analysis, timely investigations, and appropriate quality decisions.
• Collaborate with internal stakeholders, manufacturing sites, suppliers, contract manufacturers, and quality partners to ensure complaint investigations and quality records are completed in accordance with established procedures and regulatory expectations.
• Support the Supplier Quality Management Program through supplier qualification, monitoring, performance trending, issue escalation, supplier corrective action management, and quality risk assessments, as applicable.
• Assist with technical investigations involving product, process, component, and equipment-related quality issues, providing quality oversight and support for testing activities and protocol execution.
• Collect, analyze, interpret, and trend quality and operational data using appropriate statistical and risk-based methodologies to identify opportunities for continuous improvement and risk mitigation.
• Review quality system documentation and performance metrics, conduct trend analysis, and identify emerging issues requiring corrective or preventive action.
• Promote and ensure compliance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, data integrity principles, and company procedures.
• Support quality investigations, deviation management, change management, effectiveness verification activities, and continuous improvement initiatives across site quality systems.
• Prepare reports, presentations, and quality metrics to communicate findings, risks, recommendations, and quality system performance to management and stakeholders.

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Demonstrated skills in conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes
• Strong understanding of Quality System functions, manufacturing and packaging processes, validations, engineering drawings, and basic statistical processes
• Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
• Experience in preparing and participating in audits and inspections

Bonus Points If You Have (Preferred Requirements)

• Background in handling complaints and utilizing electronic lab systems
• Strong analytical and problem-solving skills
• Ability to work independently and as part of a team
• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• Experience in mentoring and training colleagues
• Experience using common AI tools, including generative technologies such as Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

PHYSICAL/MENTAL REQUIREMENTS

light lifting, ability to sit and/or walk for prolonged periods of time.

Work Location Assignment

On Premise

Last Date To Apply

October 20, 2026

Salary

The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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.

Benefits

• 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
• Health benefits to include medical, prescription drug, dental and vision coverage

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.