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ROLE SUMMARY

The Senior Director Regulatory Intelligence and Quality Standards 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 systems for monitoring, analyzing, communicating and influencing, quality-related regulations, pharmacopoeia, other standards, and inspections globally and using that intelligence to create the necessary Quality Standards, i.e. Policies and Procedures. The Senior Director Regulatory Intelligence and Quality Standards 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 Regulatory Intelligence and Quality Standards may serve as the sponsor for special/innovative/complex projects. They act as an enterprise leader.

The role requires the holder to engage in industry Trade/Professional Associations in leadership positions to represent Pfizer and influence the external regulatory environment. This role is a global role impacting all of Pfizer and interacting with Pfizer regulatory policy and strategy functions as well as US and non- US regulatory bodies and industry groups. The role also provides leadership and strategic direction to the teams that own and set the strategic direction for the Pfizer Quality Standards (PQS) which impact Pfizer Global Supply (PGS) and Pharmaceutical Sciences (PS), including all global commercial and clinical manufacturing sites, logistic centers, external supply, and above-site functions. Focus is on ensuring setting cGMP compliance related policies and standards to meet the cGMP requirements of global regulatory authorities including US FDA, EMA, MHRA, WHO, Health Canada, China, etc.

This role is a key enabler to transform intelligence gathering, influence and policy and standard setting for all Quality Operations across PGS and Pharm Sci.

ROLE RESPONSIBILITIES

• Leads a team of colleagues with responsibility for Regulatory Intelligence and Quality Standards.

• Develops, maintains and improves PGS systems and processes to identify, communicate, evaluate new and changed quality-GMDP-related regulations, and pharmacopoeia and other standards, as well as internal intelligence that may impact current Pfizer Quality Standards

• Provides risk-based analyses of the changing global quality-GMDP regulatory environment by integrating multiple sources of intelligence, brings them as applicable for discussion to the Quality Risk Review team and recommends and creates new or changed Quality Standards as needed

• Develops, maintains and improves systems and processes to gather and analyze internal and external inspection data and intelligence to support quality compliance and the effectiveness of Pfizer's Quality System including its policies and procedures

• Engages with internal stakeholders, industry organizations, and regulatory authorities, to develop and communicate Pfizer positions on the regulatory framework and thereby enable Pfizer to lead the industry conversation and facilitate delivery of our healthcare products to patients

• Interfaces with regulatory authorities on assigned programs and represents Pfizer's interests at industry forums

• Actively supports regulatory inspections as needed

• Interprets internal and external industry quality trends that may need risk review and could impact Pfizer Quality Standards

• Ensures Pfizer Quality Standards are fit-for-purpose and assure compliance to regulatory standards across the various manufacturing and supply organizations

• Develops and maintains a best-in-class procedural framework for all types of GMP documents

• Leads the Regulatory Intelligence and Quality Standards 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 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

• Experience representing organization or company externally

• Prior experience leading a regulatory intelligence and/or quality standards team

• 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

• Prior experience developing quality standards

• Prior external or internal audit experience

• Industry leadership experience

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Up to 25% travel possible

• Flexible work hours to support a global operation (sites / colleagues in different time zones)

OTHER INFORMATION

The following information, if applicable, must be manually inserted into the job description for transparency:

• Relocation eligible

• Internal candidate identified

• Eligible for employee referral bonus

• Posting expiration date (if determined)

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, Regulatory Affairs, Quality and Compliance Committees

Reports directly into VP, Operations Compliance Readiness.

Supervision

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.

OTHER INFORMATION

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