Senior Manager, GMP GDP Auditor

About this role

Use Your Power for Purpose

Regulatory Quality Assurance (RQA) is an independent Quality audit with Pfizer Global Supply (PGS) that is function accountable to identify risks and non-compliance associated with Pfizer’s GxP regulated operations. Within RQA, the GMP GDP Audit function is responsible for performing GMP /GDP audits of Pfizer facilities, contract manufacturers, suppliers and service providers involved in the manufacturing, packaging, testing and distribution of Active Pharmaceutical Ingredient (API)s, clinical trial materials and commercial biopharmaceutical products worldwide. The RQA GMP GDP Audit function is accountable to ensure Pfizer manufacturing operations are compliant with all applicable global regulations/standards and Pfizer Quality Standards. The RQA GMP GDP Audit function is required to understand GMP/GDP regulations worldwide and apply this expertise when performing audits, to provide assurance against regulator’s interpretation and expectations for compliance with cGMP/GDP requirements.

What You Will Achieve

• Independently plans/leads complex audits of material suppliers, service providers, contract manufacturers and Pfizer Country Offices, ;, performs initial, routine, for cause audits and due diligence assessments with minimum oversight

• Supports creation, testing, refinement, and adoption of AI-enabled audit tools  to advance responsible AI-enabled audit execution

• Leverages responsible use of  AI tools to support targeted audit preparation and execution

• Executes audit strategy, leads process audits and performs special assessments

• Acts as a reviewer of audit reports from outsourced or routine audits

• Assesses audit plans and quality metrics to identify potential areas of risk

• Actively supports regulatory inspections as needed

• Identifies and drives audit process improvements

• Delivers awareness sessions with oversight by manager on various GMP topics internally and externally

• Drives interactions with QA colleagues at other Pfizer locations and organizations/functional lines to ensure consistency in application of QA strategy and to promote standardization of auditing approach within QA

• Actively engages in discussions to determine impact of changing needs of the regulatory environment

• Works with RQA colleagues on cross GxP audit plans as required

• Coaches colleagues - leads training for routine and non-routine site and process audits

• Advises business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activities

• Independently, with minimal supervision, demonstrates leadership by providing clients with influence and recommendations to meet changing GMP business needs

Here Is What You Need (Minimum Requirements) •  Applicant must have a bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience

• Demonstrates advanced knowledge and understanding of global regulations (e.g., FDA, ICH, PIC’s, EMA, HC, ANVISA, TGA) and international standards (e.g., ISO, WHO)

• Applies human oversight, professional judgment, and source verification when using AI tools to support audit planning, execution, reporting, and follow-up

• Demonstrates willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies

• Demonstrates comprehensive working knowledge of business concepts and quality operations within Pfizer

• Displays critical thinking expertise, with ability to define and implement a strategic approach to audit based on compliance and business knowledge

• Strong use of quality and auditing frameworks and application

• Exhibits proficient organizational and project management skills

• Routinely suggests new audit techniques and approaches, and drives implementation to improve the audit systems

• Ability to identify trends within data and apply insights to make recommendations and decisions

• Ability to bring recommendations to stakeholders for discussion and input

• Actively leads and progresses efforts to deliver operational improvements

• Exhibits good project management capabilities

• Has domain expertise in 2 or more technical areas (e.g., API, solid oral dosages)

• Ability to work with ambiguity and adapt plan when needed

• Uses and interprets qualitative/quantitative data to drive decision making, operationalize recommendations and understand potential impact to other areas of the business

• Acts as a specialist in complex technologies (e.g., sterile biologics, small molecules, MDCP)

Bonus Points If You Have (Preferred Requirements) • Direct audit teams

• Exhibits working knowledge of data analytics and interpretation capabilities

• Demonstrates stakeholder and conflict management (communications, relationship management)

• Acquires feedback and negotiates on audit outcome with stakeholders and auditees

• Preferred experience in audits with a background in GMP, Process or other related quality areas

• Expertise in vendor audits plus 1+ technology area (MDCP, sterile biologics, small molecules, GDP’s

• Ability to function autonomously in a matrix model and in a team environment

• Provides training/mentorship to other auditors or SMEs

PHYSICAL/MENTAL REQUIREMENTS

Primarily a field-based position which includes walking, observing (physically and electronically) and lifting to assess quality and compliance risks.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to travel up to 60% of the time, including domestic and international traveling.

Work Location Assignment: Remote - Field Based 
The annual base salary for this position ranges from $124,400.00 to $207,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive progra

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