Sr Director Global Quality Intelligence, Vacancies At Pfizer, Colombo, Sri Lanka.

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  • Post Date: December 2, 2022
  • Applications 0
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Job Overview

Sr Director Global Quality Intelligence

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Role Summary

 

The Senior Director, Global Quality Intelligence, enables quality and compliance excellence that supports breakthroughs that change patients’ lives by ensuring PGS has effective systems for monitoring, analyzing, communicating and influencing, quality-related regulations, pharmacopoeia and other standards, and inspections globally. 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 US and oUS regulators and industry groups

 

Role Responsibilities

 

Develops, maintains and improves PGS systems and processes to identify, communicate, and evaluate new and changed quality-GMDP-related regulations, and pharmacopoeia and other standards, to support cost-effective regulatory compliance and trust in the company
Provides risk-based analyses of the changing global quality-GMDP regulatory environment by integrating multiple sources of intelligence and communicates these to the QO leadership team and Quality Compliance Committee
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
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
Leads the Quality Intelligence and Compliance Information Team; provides strategic direction, supports team members’ activities, and develops their capabilities
As a member of the Quality Systems Leadership Team, supports the VP Quality Systems and actively develops and contributes to network initiatives

 

Basic Qualifications

 

Bachelor’s Degree or equivalent in life sciences or relevant scientific or engineering discipline.
Minimum 15 years experience in pharmaceutical development/manufacturing/quality/regulatory function, with a deep understanding/experience of quality systems and compliance requirements, and wide knowledge of the technologies used for the development and manufacture of small and large molecule pharmaceuticals.
Deep understanding and/or experience of the regulatory systems in US and EU pertaining to the Quality development and manufacturing operations for pharmaceuticals, with a good understanding of other international regulatory frameworks and mechanisms to engage effectively with regulators.
Excellent written and verbal communications skills, and strong presentation skills. An ability to succinctly, clearly and compellingly present complex technical and regulatory positions to colleagues and senior leaders internally and externally in industry associations and regulatory agencies
High degree of emotional intelligence, professional maturity and credibility, with a proven record of successfully influencing the external regulatory environment.
Analytical and strategic thinking skills to identify and assess emerging regulatory developments and communicate the potential impact on Pfizer.
Demonstrated ability to lead people and teams in a matrix organization, including: collaborating and influencing peers, developing colleagues and overseeing their work to ensure positive outcomes, managing budgets and projects.
Fluency in English is required.
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 colleagues to achieve meaningful outcomes and create business impact.

 

 

Preferred Qualifications/Experience

 

 

Advanced degree in scientific/technical discipline
Pharmaceutical Quality/GMP experience

Non-standard Work Schedule, Travel Or Environment Requirements

Last Date to Apply – Dec 6
Ability to travel (Domestic and International) : 25%
Work Location Assignment: Flexible

For roles based in New York City: The annual base salary for this position ranges from $191,800.00 to $319,700.00. In addition, this position offers an annual bonus with a target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

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.

 

 

 

 

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Job Detail
  • Offered SalaryNot Specified
  • Career LevelManager
  • ExperienceMore than 5 Years
  • GenderBoth
  • INDUSTRYComputer and technology
  • QualificationBachelor's Degree
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