Senior Manager, GMP Process Auditor

ROLE SUMMARY

Science is the foundation of all that we do at Pfizer. We are seeking a Senior Manager GMP Process Auditor who will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through his/her/their work at a company whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career.

Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non-compliance associated with Pfizer’s GxP regulated operations.

The Sr. Manager, GMP Process Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GMP portfolio/programs/entities. This role is responsible for GMP Oversight and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations, guidelines and standards (e.g., US FDA, EU Directives, National regulations, ICH, ISO).

ROLE RESPONSIBILITIES

• Independently plans/leads/conducts and executes audit strategy wide range of (non-routine) complex audits including end to end process audits,  commercial manufacturing sites and contract manufacturers

• Designs and executes audit strategy, leads process audits and performs special assessments

• Builds Strategic Partnership with PGS to ensure identification of appropriate risk within and across GMP processes with effective communication

• Ensures agreed understanding and remediation of risk signals arising from 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

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

• Responsible for oversight for development and execution of process audit strategy to ensure audit procedures and guidelines remain aligned with applicable regulations and remain current and are effective at enabling identification of emerging risks

• Identifies and drives process improvements

• Analyze audit and inspection outcomes across GMP processes to identify potential network trends, ensure audit focus areas remain relevant and communication of any new or emerging risks to RQA and PGS stakeholders

• 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

QUALIFICATIONS

MUST-HAVE:

• Bachelor degree or equivalent, preferably in pharmaceutical or natural sciences, or equivalent

• 7+ years of experience including 2 levels; operations and auditing required

• Demonstrates advanced knowledge in ICH and global regulations (e.g., FDA, EMA, HC, ANVISA, TGA) and international standards (e.g., ISO, WHO)

• Demonstrates comprehensive working knowledge of business concepts and quality operations

• 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

• Routinely suggests new audit techniques and approaches, and operationalizes to improve the audit system

• 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

• Ability to work with ambiguity and adapt plan when needed

• Experience evaluating and understanding quality standards or their application

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