Senior Quality Assurance Compliance Specialist

In this role, you will:

• • 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

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.