Pfizer
ClinicalQualityManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Clinical Quality Manager at Pfizer. Skills: Quality Assurance, auditing, SOP development, compliance processes. Lead moderately complex projects. Co-lead moderately complex projects”
What You'll Achieve.
delivering safe and effective products; clinical practices meet highest standards; development of safe and effective treatments
Industry & Context.
problem solving; analytical skills
What They're Looking For.
Must Have
4 years of experience, 2 years of experience, understanding of Quality Assurance regulations, understanding of auditing, Proficiency in developing SOPs, Proficiency in implementing SOPs, Experience in conducting training sessions, Expertise in document manipulation, Expertise in maintaining electronic documents, Ability to work independently, Ability to manage time effectively
Nice to Have
Master’s degree, significant pharmaceutical experience, Proficiency in developing SOPs, Proficiency in implementing SOPs, conducting training sessions, Expertise in document manipulation, Expertise in maintaining electronic documents, analytical and problem-solving skills, Ability to adapt to changing priorities, Ability to manage multiple tasks, interpersonal skills, ability to build relationships, Experience using common AI tools, generative technologies experience, ChatGPT experience, Microsoft Copilot experience, Responsible AI practices understanding
What You'll Do.
Lead moderately complex projects
Co-lead moderately complex projects
Apply skills and discipline knowledge
Resolve moderately complex problems
Work independently on assignments
Review work of colleagues
Assess compliance of clinical investigator sites
Assess compliance of vendors
Assess compliance of study activities
Assess compliance of processes
Conduct audits of clinical investigator sites
Conduct audits of nonclinical laboratory studies
Conduct audits of vendors
Communicate audit findings
Ensure product compliance
Maintain CMC submission documentation
Contribute to cross-functional initiatives
Develop implementation guidelines
Improve internal quality processes
Improve internal compliance processes
Improve SOP training curricula
How You'll Work.
Team & Collaboration
cross-functional initiatives; build relationships across organization
Communication Scope
verbal communication; written communication
Process & Methodology
Project management, Time management, Resource management
Full Job Description
**Use Your Power for Purpose** Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are vital and will have a direct impact on patients. Your work will ensure that our clinical practices meet the highest standards, directly contributing to the development of safe and effective treatments. **What You Will Achieve** In this role, you will: * Lead or co-lead moderately complex projects, effectively managing time and resources. * Apply skills and discipline knowledge to contribute to departmental work. * Resolve moderately complex problems by making decisions and developing new options, guided by policies in non-standard situations. * Work independently on assignments, receiving guidance on unusual or complex problems. * Review your own work and that of colleagues in a mentor role, seeking directional review when necessary. * Utilize judgment and experience to potentially become a resource for others. * Assess compliance of clinical investigator sites, vendors, study activities, and processes against applicable regulations and guidelines. * Conduct audits of clinical investigator sites, nonclinical laboratory studies, and vendors, and communicate findings to project teams and management. * Ensure product compliance through accurate maintenance of CMC submission documentation and product knowledge in regulatory systems. * Contribute to cross-functional initiatives, develop implementation guidelines, and improve internal quality and compliance processes, including SOP training curricula. **Here Is What You Need (Minimum Requirements)** * BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of e
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