Pfizer Senior Director, Quality and EHS Risk Monitoring and Review Lead, Operations Compliance Readiness (OCR) in Helena, Montana
The Senior Director, Quality and Environmental Health and Safety Risk Monitoring and Review 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 Pfizer Global Supply (PGS) and Pharmaceutical Sciences (PS) have effective systems for monitoring, analyzing, communicating and mitigating, Quality and EHS related risk. The Senior Director, Quality and EHS Risk Monitoring and Review 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 business process owners for the Quality and EHS Risk Management and Review programs. They act as a team lead and mentor for Quality Operations colleagues and help develop and grow talent. The Senior Director, Quality and EHS Risk Monitoring and Review Lead may serve as the sponsor for special/innovative/complex projects. They act as an enterprise leader.
The role requires the holder to develop Quality Risk Management methodology and procedures aligned with principles endorsed by regulatory agencies, train the manufacturing and supply sites on this methodology, and monitor effectiveness. The Senior Director, Quality and EHS Risk Monitoring and Review Lead will critique major/critical risk assessments (in conjunction with site and SMEs) and support as needed in regulatory interactions. They will develop Risk Prioritization methodology and ensure sites adhere to risk prioritization rules. They will ensure risks are raised for discussion with the Quality Risk Monitoring and Review (QRMR) team. They will develop, facilitate, monitor, and continuously improve the QRMR process and will develop tools and systems to enable risk prioritization. They will ensure risks are discussed at the PGS Operations Sub- Committee as well as prepare risks for discussion at the PGS Quality and Compliance Committee. The Senior Director, Quality and EHS Risk Monitoring and Review Lead will develop and maintain systems and tools to collect, evaluate, prioritize and discuss key risks.
This role is a key enabler to transform risk monitoring and review for all Quality and EHS Operations across PGS and Pharm Sci.
Leads a team of colleagues with responsibility for Quality Risk Management (QRM) and for the Quality Risk Monitoring and Review program.
Serves as the business process owner for QRM
Works transversely with other above site functions within PGS and Pharm Sci that have responsibility for risk assessments and ensure consistent application of risk assessment process, risk leveling methodology, systems and tools
Develops, maintains and improves PGS systems and processes to identify, communicate, evaluate new and changed quality (GMDP) and EHS related risks
Provides a risk prioritization process by which sites can escalate risks for discussion with the Quality Risk Monitoring and Review team
Develops, maintains and improves systems and processes to gather and analyze internal risk related data and intelligence to support risk prioritization, and to ensure quality and compliance and the effectiveness of Pfizer's Quality System
Actively supports regulatory inspections as needed
Works with the Regulatory Intelligence and Quality Standards team to interpret internal and external industry quality trends that may need risk review
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 a Quality Risk Management function
Familiar with Quality Risk Management (ICH Q9, ISO 14971, etc.)
Experience representing organization or company externally
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
25% travel possible
Flexible work hours to support a global operation (sites / colleagues in different time zones)
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, Site EHS leaders, Quality and Compliance Committees
Reports directly into VP, Operations Compliance Readiness
Has responsibility for Team leads and colleagues responsible for Risk Monitoring and Review. Manages a typical number of 4-6 direct reports. May manage contingent workers depending on business need.
OTHER 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.
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