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.