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Pfizer Senior Director, Quality and EHS Risk Monitoring and Review Lead, Operations Compliance Readiness (OCR) in Denver, Colorado

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

  • 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

QUALIFICATIONS

BASIC QUALIFICATIONS

  • Bachelor's degree

  • 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

PREFERRED QUALIFICATIONS

  • 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)

ORGANIZATIONAL RELATIONSHIPS

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

Supervision

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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

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