Pfizer

Director, Quality - Data Science

Posted on: 4 Apr 2021

New York City, New York

Job Description

ROLE SUMMARY

Science is the foundation of all that we do at Pfizer. We are seeking a Director, Quality Data Science who will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through his/her/their work at a company whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career. Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non-compliance associated with Pfizers GxP regulated operations. In this role, the Director, Quality Data Science will be responsible for defining and executing Good Practice (GXP) digital and data science strategies in support of risk management, quality strategy, GXP audit strategy and governance goals and objectives. This colleague will act as a leader in the Regulatory Quality Assurance (RQA) group and partner with the quality, corporate audit and digital/analytics groups across Pfizer to determine optimal approaches, including data and hypothesis driven analytics, to drive risk assessment, determine audit strategies and measure the effectiveness of GXP processes. As a quality data expert, the Director, Quality Data Science will be responsible for monitoring emerging technologies and industry trends to inform the development of novel analytic solutions and positioning Pfizer as industry leader.

ROLE RESPONSIBILITIES

Leadership

* Acts as a leader, influencing leadership, and peers within RQA and peers across functional lines to develop consistent and transparent digital and data science strategy for RQA

* Partners with functional lines, leveraging expertise, to provide end-to-end and holistic approach to digital and quality analytics and audit

* Maintains relationships and builds partnerships with internal and external stakeholders to drive data science capabilities and innovation

* Leads and supports consultants / colleagues as applicable

Digital Strategy / Data Science

* Set vision for data/analytics roadmap; solving complex data problems across the quality/risk management continuum

* Partner with digital and business to support data science infrastructure and capabilities including data lake build; data lake co-ownership to ensure robust/validated technical process

* Partner internally and cross-functionally on a hypothesis driven analytics strategy across quality business lines to ensure a strategic, optimized and consistent approach (data standards) to metrics, thresholds, etc. that meet stakeholder needs

* Work with functions and governance to develop hypotheses for testing effectiveness of the Quality Management System (QMS); Develop hypotheses to test / answer critical business questions across GXP, leveraging descriptive & statistical methods (examples include: effectiveness of processes, gaps in the quality management system, emerging risk, ability to self-identify quality issues through internal controls)

* Mine internal & external intelligence data and factor into risk strategy to ensure cohesive approach; Build partnerships / access external data including regulatory, third party if applicable, etc.

* Work with QMS Oversight and analytics team to construct complex analytics (KRIs / KPIs / other); communicate findings/insights/trends to applicable functions

* Data/Analytics for continuous monitoring of GXP areas; Explore opportunities for continuous / automated auditing; leverage analytics and machine learning to check for data quality, detect outliers and anomalies, or identify and prioritize high-risk patterns

* Design/build (and/or assess validity of existing L1) predictive models (for risk/quality management) including POC, ROI. to support risk assessment & oversight decisions

* Review data/trends in support of QMS oversight to determine impacts and needed oversight actions based on elevated issues/trends

* Assess and influence/ensure data quality / validation procedures including documentation, storage (per policies)

* Explore/implement technology advancements including NLP, AI, etc. (including external benchmarking to pharma and other tech advanced companies)

* Design processes to ensure integration data are connected to Risk Strategy processes

* Set strategy to up-skill colleagues as applicable to ensure data-culture and data-focused mind-set

* Ensure that our models to predict risk, etc. can be well explained (internally and to a regulator), avoid bias, are readily supported/POCs can be scaled and are continuously calibrated (to ensure inputs/outputs remain true/relevant); ensure controls are in place to manage risk of data models

* Provide objective assessments to assist leadership in prioritizing investments in data-science capabilities/projects

* Assist GXP audit teams in exploring methodologies to enhance audit strategy based on emerging innovation and technology advancements

Experience

* Understanding of Data Science and proven experience developing requirements and deploying ML/AI/NLP/Data Visualization based Applications
* Designed Data Science Models
* Development/Deployment/Operations of Data Science Models & Operations
* Experience building and optimizing big data data pipelines, architectures and data sets.
* Experience with AWS cloud services: EC2, EMR, RDS, Redshift, Dataiku
* Experience with Solutions that aid analysis of trends and identification of Signals in Data whether in Quality of other disciplines.

Operational Excellence

* Accountable for design and timely delivery of the digital / data science strategies

* Accountable for ensuring validation / controls in place to support data science capabilities and models

* Collaborates with RQA peers and internal / external stakeholders to drive purposeful digital strategy

* Works to ensure quality standards are consistently applied across the program or region

* Proactively identifies opportunities for improvement within RQA

* Maintains current knowledge of industry trends that impact data science capabilities and strategies

* Monitors and maintains expertise in area(s) of focus

Skills

* Data Science based Model development
* Data Transformations/ETL tools Alteryx, Informatica, Dataiku
* Data Visualizations
* Tableau, Spotfire, Alteryx, Python
* Experience with big data tools/Environments: Hadoop, Spark, Kafka, AWS , Redshift, SQL Query Engine (Presto), Dataiku
* Advanced knowledge working with relational SQL and NoSQL databases.
* Advanced experience with object-oriented/object function scripting languages: Python, Java, C++, Scala, etc.
* Desired Experience with at least one Deep Learning framework such as TensorFlow/Keras, or PyTorch
* Demonstrated ability to write high-quality, production-ready code (readable, well-tested, with well-designed APIs)
* VEEVA deployment, Configuration, Operations management

BASIC QUALIFICATIONS

* Advanced academic qualification/degree in data science / statistics / computer science is required (e.g. Masters or PhD); equivalent relevant professional experience will be considered.

* 10+ years of relevant experience in data science and analytical tools/techniques/technologies

* Project management and leadership experience with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities a plus

* Ability to function autonomously in a matrix model and in a team environment

* Proven ability to think innovatively and to develop and execute strategic plans pursuant to the responsibilities of the role

* Knowledge of GXPs / quality

* 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.

Other Job Details:

* Last Date to Apply for Job: April 12, 2021
* Additional Location Information: Collegeville, PA; Groton, CT; Lake forest, IL; New York, NY; Peapack, NJ; Global - Any Pfizer Site; Global - Remote; UK - Remote; Sandwich, UK; Walton Oaks, UK
* Eligible for Employee Referral Bonus

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 providers 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

Pfizer

New York, New York

Pfizer Inc. develops, manufactures, and sells healthcare products worldwide. It offers medicines and vaccines in various therapeutic areas, including internal medicine, vaccines, oncology, inflammation and immunology, and rare diseases under the Lyrica, Chantix/Champix, Eliquis, Ibrance, Sutent, Xalkori, Inlyta, Xtandi, Enbrel, Xeljanz, Eucrisa, BeneFix, Genotropin, and Refacto AF/Xyntha brands. The company also provides consumer healthcare products that comprise over-the-counter medicines, including dietary supplement products under the Centrum, Caltrate, and Emergen-C names; pain management products under the Advil and ThermaCare names; gastrointestinal products under the Nexium 24HR/Nexium Control and Preparation H names; and respiratory and personal care products under the Robitussin, Advil Cold & Sinus, and ChapStick names. In addition, it offers products that would lose or have lost marketing patent protection; branded generic products; generic sterile injectable products; biosimilars; and anti-infectives under the Lipitor, Premarin family, Norvasc, Lyrica, Celebrex, Viagra, Inflectra/Remsima, Zyvox, Vfend, Revatio, Inspra, Medrol, Sulperazon, Fragmin, Tygacil, Nivestim, and Retacrit, Ixifi Infliximab BS names.

Further, the company is also involved in the contract manufacturing business. It serves wholesalers, retailers, hospitals, clinics, government agencies, pharmacies, and individual provider offices, as well as disease control and prevention centers. The company has collaboration and/or co-promotion agreements with Bristol-Myers Squibb Company, Astellas Pharma US, Inc., and Oncolytics Biotech Inc.; licensing agreement with BionTech AG; strategic alliance with Verily Life Sciences LLC; and collaboration agreements with Pfizer, Merck & Co., Inc., and Eli Lilly & Company, as well as with Merck KGaA and Nektar Therapeutics to develop a therapy for treating pancreatic cancer. Pfizer Inc. was founded in 1849 and is headquartered in New York, New York.

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