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Director, Quality

4 months ago


New York, New York, United States Pfizer Full time
ROLE SUMMARY

The Director, Quality Digital Team Lead is responsible for the development and implementation of digital innovation and electronic system strategies to assure high quality, effective, optimized and efficient Regulatory Quality Assurance ( RQA) programs, and effective Quality & Risk Management across the enterprise. This includes business ownership of key systems that support quality objectives. This role provides oversight of technology infrastructure and system initiatives for all groups in R QA (GCP, PV, GLP, GMP, Inspection Management, Quality Management System and Operations) to ensure alignment between process, technology and culture. The Director, Digital ensures business excellence by driving process improvement, digital innovation, simplification, special projects and efforts focused on advancement of technology and seamless integration of R QA activities and results to the broader Pfizer Quality Management System.

This role acts as a partner to the RQA leadership team/ audit & inspection leads, Digital, and other quality groups in Pfizer.

ROLE RESPONSIBILITIES

Primary Responsibilities
Provides leadership and ownership of all electronic systems and applications within RQA to ensure a cohesive and sustainable technology and data strategy across all groups internally and externally
Manages team of quality professionals and contractors who are responsible for driving system strategies, quality/compliance objectives and continuous improvement
Partners strategically with Data & Analytics leader to drive common, connected and robust infrastructure and digital roadmap to enable advanced user experience across integrated technologies in support of auditing
Partners strategically with Business Process Owners and Operations to ensure alignment across people, process and technology advancements, including process user councils and program governance
Serves as Quality leader across the enterprise for advancements in support of Quality Management System endeavors; leads and supports Systems governance in partnership with digital
Formulates recommended strategies to maximize effectiveness, accuracy and efficiency of processes and systems
Prioritizes investments in technology in conjunction with appropriate governance boards and Pfizer Digital; Accountable for the RQA Digital budget
Provides subject matter expertise, thought leadership and vision in quality digital systems across multiple systems/sources to create actionable insights that drive execution of the enterprise Quality strategy
Provides technical expertise to RQA and guides functional groups to ensure system requirements are identified, designed, and distributed appropriately to highlight and interpret issues, trends, and variances within the data
Identifies and champions improvements to processes and technologies to help achieve RQA's/Quality's business objectives, promote efficiencies and productivity and to enhance partner satisfaction
Ensures that technology and reporting tools are seamlessly integrated across business functions and implements training programs to allow colleagues to effectively utilize system reporting functionality
Serves as technology SME on various committees, with respect to Processes and Systems, including Vox/GenAI
Provides updates and training on trends and issues related to business processes and support technologies to the RQA LT and colleagues
Collaborates with Pfizer Digital to identify business requirements and implements systems solutions that streamline and/or re-engineer processes and automate operations
Strategically partners with Digital to ensure proper data excellence, quality and governance for all systems leveraged for quality objectives
Monitors emerging technologies and industry trends to inform the development of novel analytic solutions and positioning Pfizer as industry leader
Accountable for ensuring validation / controls in place to support digital and data science capabilities
Represents Pfizer externally asapplicable

People Management
Provides management to appropriately qualified/skilled digital audit, data science and technology professionals to meet the technology and operational needs of RQA and to optimize skill utilization across a matrix organization
Determines colleague skills and drives the global integrated talent pool in alignment with the RQA strategy and audit process, as appropriate
Responsible for staff talent development, career development and performance management
Provides current and strategic direction, as well as complete, actionable, positive and corrective feedback to others
Assigns clear responsibility for tasks and decisions, empowers the team to independently execute on responsibilities and find solutions, sets clear objectives and measures, monitors process/progress/results, and designs feedback loops into work

QUALIFICATIONS

MUST-HAVE:
Bachelor's degree or equivalent required
10+ years of relevant experience
Experience in Quality Systems and GxP
Expertise in digital technologies, applications and digital architecture
Experience leading cross-functional teams to plan and implement processes and systems to optimize business operations
Global perspective within the context of business needs and impact
Demonstrated business acumen in applying technology to support and improve business processes
System fluency on relevant Pfizer information systems utilized by RQA
Expertise in data science, analytics and reporting applications
Proven accountability and demonstrated excellent interpersonal, communication, negotiation, influencing, presentation development and problem-solving capabilities
Proven project management capability and ability to execute against timelines
Experience evaluating and understanding quality standards or their application
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.

NICE-TO-HAVE:
Advanced degree in technology area strongly preferred
Qualification in Project Management or equivalent, a plus
Continuous improvement expertise, a plus

Other Job Details:
Last Date to Apply for Job: May 28,2024Additional Location Information: Global - Any Pfizer Site Work Location Assignment:Must be able to work from assigned Pfizer office 2-3 days per week, or as needed by the business

The annual base salary for this position ranges from $161,600.00 to $269, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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. This position requires permanent work authorization in the United States.

Quality Assurance and Control

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