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Document Quality, Manager

Employer
Pfizer
Location
New York City, New York, United States; Collegeville, Pennsylvania, United States;
Salary
Competitive
Closing date
Feb 25, 2024

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Discipline
Other, Manufacturing/QA/QC
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

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

Support Safety Quality (SQ) and Document Quality and Compliance (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. Serves as SQ DQC point of contact and Subject Matter Expert (SME) for quality.

How You Will Achieve

  • 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.
  • Lead 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 Lightspeed1 programs/products and accelerated submissions.
  • Leads project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality processes, process improvement initiatives, and strategies supporting accelerated advancement of products.
  • Actively participates/leads in the investment and strategy decisions related to technology enhancements.
  • Leads support activities for regulatory inspection and internal audits which may include requirements related to Lightspeed projects and/or high profile products.
  • Compiles and analyzes quality metrics on a routine basis, and periodically reports trends relating to document quality review.
  • Manages the completion of complex tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses and corrective action planning with customers, as necessary.
  • Serves as quality SME on training, knowledge sharing, technology or specific work processes, providing advice and guidance as appropriate.
  • Participates in the development of people, including recruitment and retention, working with the SQ DQC Team Leads to provide support to other colleagues across all sites.
  • Participates in the development of work guides, training materials.
  • Assists in developing recommendations for cross-Pfizer processes to ensure alignment with quality goals and other groups performing similar functions.


Qualifications

Must-Have
  • BS degree (or equivalent) with +5 years of experience or Master's degree with +3 years of experience.
  • 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.
  • Broad knowledge of global safety regulations and guidelines, or equivalent.
  • Innovative and strategic thinking ability.
  • Extensive clinical development and/or post-marketing and business experience to have a thorough understanding of the processes associated with clinical safety and regulatory operations.


Nice-to-Have
  • A health care, scientific or technical degree is preferred.


Technical Skill Requirements
  • Strategic Thinking - Demonstrated ability to understand and consider competitive positioning when solving problems and making decisions, especially for programs/products with Lightspeed1 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.
  • 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.
  • Strategic Thinking - Demonstrated expertise and ability to understand and consider competitive positioning when solving problems and making decisions, especially for programs/products with Lightspeed1 designation and accelerated submissions.
  • Clinical, Regulatory and Safety Expertise - General understanding of medical terminology and extensive knowledge of clinical research processes, safety or regulatory requirements.
  • Technical Expertise - Applies broad-based technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line. Strong risk management expertise.
  • Project and Process Management and Meeting Established Deadlines - Demonstrated ability to lead multiple complex projects and cross-functional processes independently, and to meet established deadlines. Flexible approach to working schedule may be required.
  • Presentation/Influencing/Organizational Skills - Excellent platform skills evident.
  • Multitasking - Demonstrated ability to effectively and independently work on simultaneous complex projects/deliverables.
  • Analytical and Statistical Skills - Extensive analytical and statistical skills.
  • Systems Technologies - Comprehensive understanding and expertise with system technologies that support the business.
  • Proficient with software commonly used to present and analyze data (Word, PowerPoint, and Excel) required.
  • Excellent analytical skills with experience in generating business metrics highly desirable.
  • Previous experience in KPIs dashboard and data visualization highly desirable.
  • Demonstrated ability to collaborate effectively with team members and interact at all levels of an organization.
  • Demonstrated ability to analyze, evaluate, understand processes quickly, and identify gaps, issues and opportunities for improvement.
  • Strong orientation to detail and ability to function independently as appropriate.
  • Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multitasking skills.
  • Ability to engage colleagues globally and will do so in a manner that recognizes the organizational and cultural differences may exist between their partners around the world
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
  • Can manage multiple deliverables/projects simultaneously, prioritizing well and recognizing key issues and recommends course of action to management.


Other Job Details:
  • Work Location Assignment: On Premise
  • On Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.


The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's 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 life's 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 | (uscandidates.mypfizerbenefits.com). 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.

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.

Quality Assurance and Control

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