Clinical Quality Manager

Responsibilities

• Lead or co-lead moderately complex clinical quality projects, managing time and resources effectively.
• 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, communicating 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 to improve internal quality and compliance processes, including SOP training curricula.
• Resolve complex problems by developing new options and making decisions guided by departmental policies.

Requirements

• BA/BS with at least 4 years of experience, or an equivalent combination of education and relevant experience.
• Strong understanding of Quality Assurance regulations and auditing expertise.
• Proficiency in developing and implementing Standard Operating Procedures (SOP).
• Experience in conducting training sessions and facilitating learning.
• Expertise in document manipulation and maintaining electronic document management systems.
• Strong verbal and written communication skills with the ability to work independently.

Preferred Qualifications

• Master’s degree coupled with significant pharmaceutical industry experience.
• Strong analytical and problem-solving skills.
• Ability to adapt to changing priorities and manage multiple tasks simultaneously.
• Experience using common AI tools, such as generative technologies, to support problem-solving and enhance productivity.

About the Company

Pfizer is a global leader in the pharmaceutical industry, driven by an unwavering commitment to delivering safe and effective products to patients. We foster a culture of individual ownership and science-based compliance to unearth innovative therapies that transform millions of lives and make the world a healthier place.