Job Description

Responsibilities:

• Perform quality reviews to ensure accuracy, consistency and completeness of documents deemed for regulatory submission in accordance with agreed upon timelines. Quality reviews will potentially include Lightspeed programs/products and accelerated submissions.
• Collaborates with document authors and other team members to address and resolve quality observations. Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes, process improvement initiatives, and strategies supporting accelerated advancement of products.
• Participates in the investment and strategy decisions related to technology enhancements.
• Supports regulatory commitments and expectations, including commitments for programs within accelerated timelines.
• Maintains knowledge of global regulatory requirements relative to pharmacovigilance and regulatory submission requirements. Provides support for regulatory inspections and internal audits which may include requirements related to Lightspeed projects and/or high profile products.
• Provides mentoring and training for colleagues as necessary, working with Team Leads to provide support across all sites.
• Actively participates in the investment and strategy decisions related to technology enhancements. May serve as quality Subject Matter Expert (SME) on training, knowledge sharing, technology, or specific work processes, providing advice and guidance as appropriate.

Education:

• A health care, scientific or technical degree is preferred.
• BS degree (or equivalent)

Experience:

• Minimum 5-8 years of experience in clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry.
• Experience in quality control and/or quality assurance within the pharmaceutical industry preferred.
• Knowledge of global safety regulations and guidelines, or equivalent.
• Demonstrated strength in analytical skills and attention to detail.
• Demonstrated strength in oral/written communication and interpersonal skills.
• Demonstrated organizational/project management skills.
• Ability to make decisions independently and resolve issues appropriately.
• Demonstrated computer literacy, particularly in the use and management of relational databases.
• Innovative and strategic thinking ability.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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Pfizer