Principal Scientist: ARD Compliance Lead
- United States - Connecticut - Groton
Use Your Power for Purpose
At Pfizer, our purpose is to deliver breakthroughs that change patients’ lives. Your role will be pivotal in translating advanced science and technologies into impactful therapies and vaccines, ultimately improving patients' lives. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, you will leverage cutting-edge design and process development capabilities to accelerate and deliver best-in-class medicines to patients globally.
What You Will Achieve
Support the delivery of ARD compliance, instrumentation, and GMP data processes including data integrity strategy. This matrixed role will interface across ARD as well as with our strategic partners to ensure compliance with applicable procedures and policies and the implementation of robust GMP data processes. The candidate must be able to interact effectively with highly interdisciplinary teams, in a cross functional environment. This candidate is accountable for enhancing the overall Quality culture and maintaining an audit and inspection ready state (in partnership with ARD management).
The purpose of this position is to ensure a strong compliance culture and maintain processes to drive high standards of data integrity, quality, and compliance. The candidate will proactively drive departmental initiatives to enhance the overall Quality culture and continue the development and implementation of GMP data processes across ARD. The candidate will liaise with appropriate departments, functions and SMEs regarding compliance and data integrity related programs, questions, and communications.
This role will also focus on compliance with applicable SOPs, policies, and compliance. This role could also include investigations authoring point of contact/author, CAPA management, eQMS support, vendor support, ARD Quality Council representation, instrument validation lifecycle support, and other compliance responsibilities to enhance the overall Quality Culture within ARD and drive compliance and quality standards.
Accountability for continuous improvement initiatives for the ARD organization in areas such as data review, specification review and approval, Instrument systems, ARD project team interfaces with GMP functions and data integrity initiatives are important for this role. The role will also assist teams in continuous improvement efforts at the interface of ARD laboratory quality systems and bridging technical needs with quality requirements.
Additional responsibilities are/may be:
Managing compliance related metrics
Optimization and implementation of Pfizer Revolution processes that impact or potentially impact ARD, including review and oversight.
Contribute/lead to the ARD Compliance Forum and support Quality Council and similar Quality leadership efforts and initiatives.
Partner with other business lines to develop and implement instrument and equipment validation lifecycle processes that incorporate regulatory guidance and Pfizer compliance expectations
Support audit and compliance strategy implementation efforts, including inspection readiness training, coordination of audits and inspections, CAPA resolution, and timely response to audit activities.
Support data integrity efforts as needed, including detection of potential gaps and partnership with laboratory personnel for remediation efforts
Support/Contribute to GA involvement in AMTE unit of work, including engagement and implementation of the updated Revolution AMTE processes, participation in AMTE protocol/report oversight and SME in AMTE process for ARD.
The colleague must work within corporate guidelines and must appropriately record, archive and report all data in a compliant manner.
The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team.
Qualifications
Must Have
BA/BS with at least 12 years of experience, or MBA/MS with at least 9 years of experience, or PhD/JD with 4 to 8 years of experience in a quality or compliance related field
Experience with data integrity approaches and instrument qualification strategy is preferred.
Experience working in a regulated environment (e.g. GLP, cGMP).
Proven record of strong technical skills and scientific expertise in equipment validation
Proven record of delivering results in a fast-paced environment and effective communication to project teams and external partners (e.g. regulatory authorities).
Familiarity with technologies focused on the analysis of biomolecules and conjugates
Demonstrated technical writing and presentation skills
Exemplary leader behaviors and the ability to collaborate with and mentor others is a must.
Nice to Have
Direct experience working with auditors or inspectors e.g. FDA or European regulatory authorities.
Experience in GMP environment and implementation of continuous improvement practices.
Working knowledge of Quality Management Systems, quality tracking systems and Risk management.
Proficiency in general analytical techniques
Experience in strategic planning and resource management including team-based, fast-paced environments where multi-tasking is required
A record of external presentations (oral, poster and/or publications) in relevant field
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Relocation support available
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Research and Development
Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)