Pfizer Senior Director, Internal Audit and Inspection Management Lead, Operations Compliance Readiness (OCR) in Frankfort, Kentucky
The Senior Director, Internal Audit and Inspection Management Lead reporting to the VP, Operations Compliance Readiness, is responsible for enabling quality and compliance excellence that supports breakthroughs that change patients' lives by ensuring PGS and Pharm Sci have effective processes and systems for site internal audit, inspection readiness, inspection management and health authority interactions aligned with regulatory expectations. The Senior Director, Internal Audit and Inspection Management Lead interfaces with senior leaders and cross-functional business process owners and secures resources necessary to execute on the strategy. They lead a team of senior quality professionals primarily responsible for executing programmatic elements and serving as quality business process owners. They act as a team lead and mentor for Quality Operations colleagues and help develop and grow talent. The Senior Director, Internal Audit and Inspection Management Lead may serve as the sponsor for special/innovative/complex projects. They act as an enterprise leader.
This role is responsible for managing all aspects of the Level 1 (site) audit business process. They develop procedures, guides and training for all Level 1 auditors, monitor site auditor performance and audit effectiveness, develop contractual agreements with external auditor training/certification organizations to maintain lead auditor certifications within PGS and Pharm Sci. They serve as the point of contact for all audit related interfaces with Level 2 and 3 audit, monitor data and intelligence and use the same to support inspection readiness activities. They coach/guide internal auditors, and site compliance colleagues on new regulation and high-risk areas to focus inspection readiness activities. This role is responsible for performing on-site inspection readiness activities in addition to supporting Inspection Management activities, supporting the response writing process with appropriate harmonized tools/templates. They monitor inspection closeouts and work with quality leaders to determine if multi-site or network wide CAPAs are required. They maintain DI programmatic elements throughout network. With appropriate network SME support they are responsible for developing appropriate procedures and training in Data Integrity, Internal Audit and Inspection Readiness and Management. They develop and maintain system ownership/admin for tracking audit/inspection/ regulatory agency interactions (inspection daily summaries, Health Authority queries, responses, etc.).
This role is a key enabler to transform Internal Audit, Inspection readiness and management processes for all Quality Operations across PGS and Pharm Sci.
Leads a team of colleagues with responsibility for processes and systems governing Internal Audit, Data Integrity, Inspection Readiness and Management.
Identifies and mitigates quality risk through internal audit, data integrity and inspection readiness systems and processes
Through intelligence gathering and data mining of internal and external quality data, provides risk-based analyses of internal audit and regulatory inspection trends and brings them as applicable for discussion to the Quality Risk Review team to determine network risk prioritization
Engages with internal stakeholders, such as Regulatory Quality Assurance (RQA) and Corporate Audit (CA) to recognize and communicate risk trends.
Ensures focused assessments are performed with support from technical teams as needed and tracks risks and actions from an inspection readiness perspective
Actively supports regulatory inspections as needed
Leads the Internal Audit and Inspection management team; provides strategic direction, supports team members' activities, and develops their capabilities
Demonstrates expertise in multiple knowledge areas, maintains a wide breadth of knowledge, and stays up to date on current industry trends
Represents the OCR organization on relevant governance committees
As a member of the Operations Compliance Readiness (OCR) Leadership Team, supports the VP OCR and actively develops and contributes to network initiatives
A minimum of 15 years' experience the pharmaceutical industry or related areas
Strong knowledge of quality and manufacturing operations
Strategic leadership of Quality or Compliance teams
Prior experience leading an GMP Audit or Inspection Management function or prior experience within a major/global regulatory inspectional function
Demonstrated ability to lead complex projects and cross-functional processes, to establish and meet deadlines, work within tight timeframes, and respond to changing requirements
Demonstrated change agility to successfully manage high degree of complexity and priorities
Demonstrated excellence in developing & managing effective teams
Proven ability to coach/mentor colleagues and to grow and develop talent
Experience managing performance of group and holding team accountable for internal KPIs
Highly experienced and proven ability in enterprise leadership and execution of business practices
Demonstrate experience managing budgets, strategic resource management ownership
Demonstrate advanced critical thinking capabilities (e.g. synthesize key insights, and complex problems clearly and precisely, uses inference to reason to important implications and consequences, uses deductive reasoning consistently and with ease to drive effective solutions or programs)
Ability to drive continuous improvement strategy and operational improvement opportunities
Must have exceptional written and oral communication skills to support succinct and effective communications between internal / external stakeholders
Ability to engage correct path for stakeholder engagement
Ability to guide the use of technology to recognize and interpret trends
Ability to identify risks, propose mitigation and escalate as needed
Well-developed interpersonal skills with ability to collaborate across PGS functions and work effectively across all levels of the organization
Proactively communicate and influence VPs & major enterprise-wide committees
An advanced degree is preferred.
5+ years in a people management role preferred (or equivalent) with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
Industry leadership experience
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Up to Here 25% travel possible
Flexible work hours to support a global operation (sites / colleagues in different time zones)
Provide the primary groups or key role(s) that this role will interact with as a regular part of the role responsibilities. Include any external interactions as appropriate.
Is responsible for interacting and partnering with functional groups within OCR and across Quality Operations and EHS (QO/EHS) as well as externally across various other PGS and Pfizer stakeholder groups such as QO/EHS Leadership Team, Pfizer Global Supply Leadership Team specifically Quality Operations Leaders, Site Leaders, Site Quality Leaders, Regulatory Quality Assurance, Corporate Audit, Quality and Compliance Committees
Reports directly into VP, Operations Compliance Readiness.
Has responsibility for Team leads and colleagues responsible for Regulatory Intelligence and Quality Standards. Manages a typical number of 10 to 20 direct and indirect reports. May manage contingent workers depending on business need.
ADDITIONAL POSITION DETAILS
Last Date to Apply: March 31, 2023
Location details: Can be remote
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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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.
Quality Assurance and Control