Document Quality, Manager

Use Your Power for Purpose

Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative always putting the patient first. Whether you are involved in development maintenance compliance or research analysis your contribution directly impacts patients.

Position Purpose

• Conduct QC activities on Safety deliverables and clinical submissions ensuring accuracy internal consistency uniformity and compliance with regulatory commitments and expectations.

• Support SQ and DQC management in the development and implementation of strategies for operationalizing quality checks/QC metrics and processes to enable effective oversight of safety and regulatory quality. Serve as SQ DQC point of contact and Subject Matter Expert (SME) for quality.

Key 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 programs/products with accelerated designations 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.
• Actively 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 accelerated projects and high-profile products.
• Provides mentoring and training for colleagues as necessary working with Team Leads to provide support across all sites.
• May serve as quality Subject Matter Expert (SME) on training knowledge sharing technology or specific work processes providing advice and guidance as appropriate.

Qualifications

• Bachelors degree (or equivalent) required scientific field preferred
• Minimum 3 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.

Technical Skill Requirements

• Strategic Thinking - Demonstrated ability to understand and consider competitive positioning when solving problems and making decisions especially for programs/products with accelerated designation and accelerated submissions.
• Clinical Regulatory and Safety Expertise General understanding of medical terminology and demonstrated knowledge of clinical research processes safety or regulatory requirements.
• Technical Expertise Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line.
• Project and Process Management and Meeting Established Deadlines Demonstrated ability to contribute to projects and cross-functional processes and to meet established deadlines. Flexible approach to working schedule may be required.
• Presentation/Influencing/Organizational Skills Strong platform skills evident.
• Multitasking Demonstrated ability to effectively work on simultaneous projects/deliverables.
• Analytical and Statistical Skills Demonstrated analytical and statistical skills.
• Systems Technologies Thorough understanding of system technologies that support the business.

Work Location Assignment:Hybrid

The annual base salary for this position ranges from $96300.00 to $160500.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 12.5% 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 lifes 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.

Quality Assurance and Control