PSOQ Audit, Inspection Management and Regulatory Surveillance Strategic Process Lead

About this role

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

Role Summary

• This Quality position is considered a global position and reports into the Pharmaceutical Sciences Operations Quality (PSOQ) Strategic Compliance Team as part of a group responsible for the management, performance, advancement and oversight of the Quality Management System strategy across the global Pharmaceutical Sciences (PharmSci) Organization. • The PSOQ Audit, Inspection Management and Regulatory Surveillance Strategic Process Lead will perform a range of duties within the PharmSci Operations Quality team associated with management, performance, continual improvement and oversight of the Audit, Inspection and Regulatory Surveillance Quality System processes to ensure consistency and compliance with regulatory expectations, Pfizer Global Quality Standards and policies and procedures across the global Pharmaceutical Sciences organization. • Works with PharmSci, Pfizer Global Supply (PGS) Center Functions (Including Regulatory Quality Assurance (RQA) and Corporate Audit) and Partner Lines to align goals as well as help develop and support the implementation of effective quality system solutions. 

What You Will Achieve

In this role, you will: • Lead, develop and support execution of PharmSci Audit strategic plan • Work in partnership with RQA on the internal audit plan. • Analyze data to support audit and inspection management, regulatory compliance, and strategic planning. • Instrumental in ensuring that the audit, inspection management and regulatory surveillance quality systems are a competitive advantage for PharmSci.  Achieves this through continued collaboration across the PharmSci network to standardize practices, help implement Global Inspection Management Systems and Tools and gain efficiencies in key focus areas of the system such as audit and inspection readiness, management and sustainable regulatory compliance.  • Implements strategies for performance improvement and deploys metrics to determine effectiveness.  • Analyze metrics and feedback for opportunities to improve effectiveness and align with process and stakeholder needs.   • Partners with PharmSci Business Lines, RQA and PGS to develop procedures and appropriate implementation plans for the management of audits, inspections and regulatory information.  • Partners with business lines in the development, implementation and management of their audit and inspection readiness.  • Supports the management of the audit, inspection and regulatory information systems for PharmSci.  • Functions as a Quality System Subject Matter Expert and provides support for corporate and regulatory audits.  • Reviews SOPs, determines gaps and provides input in relation to audits, inspections and regulatory information.  • Provides audit, inspection and regulatory surveillance Subject Matter Expertise to global and site customers.  • Leads and participates in various projects in support of organizational strategy and priorities.  • Provide stakeholder management and communications for audit, inspection management and regulatory surveillance activities and changes.  • Ensure thatbusiness utilization of audit, inspection and regulatory information-process related systems is effective and efficient to achieve the desired strategic outcome.  • Lead the audit, inspection management and regulatory surveillance Communities of Practice and provide stakeholder management and communications for audit, inspection management and regulatory surveillance activities and changes. • Provides regular reporting and results to quality councils, management teams and stakeholders. • Identify areas to improve audit, inspection management and regulatory surveillance process operational efficiency, effectiveness, and integration with regards to end-to-end drug development processes. • Develop culture of strong inspection readiness across Pharmaceutical Sciences and related stakeholders. • Ensure that business utilization of the audit, inspection management, and regulatory surveillance process related systems is effective and efficient to achieve the desired strategic outcome. • Actively monitors and maintains industry-wide expertise in audit, inspection management and regulatory surveillance.

Here Is What You Need (Minimum Requirements)

• BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience • Demonstrated diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and coach others, and create significant business impact • Audit Certification, management and performance. • Strong Board of Health, Regulatory and Audit experience • Strong GMP/GDP audit, inspection and quality oversight skills • Strong project management, organization, and planning skills • Excellent written and verbal communication and collaboration skills

Bonus Points If You Have (Preferred Requirements)

• A Master's degree with relevant pharmaceutical experience • ISO Audit experience • Strong analytical and problem-solving skills • Ability to work in a fast-paced environment • Experience using common AI tools, including generative technologies such as ChatGPT or 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

  Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleag

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