Clinical Quality Manager

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 experience or associate's degree with at least 8 years of experience or high school diploma (or equivalent) with at least 10 years of relevant experience
• Strong understanding of Quality Assurance regulations and auditing
• Proficiency in developing and implementing Standard Operating Procedures (SOP)
• Experience in conducting training sessions
• Expertise in document manipulation and maintaining electronic documents
• Strong verbal and written communication skills
• Ability to work independently and manage time effectively

Bonus Points If You Have (Preferred Requirements)

• Master’s degree coupled with significant pharmaceutical experience
• Proficiency in developing and implementing SOPs and conducting training sessions
• Expertise in document manipulation and maintaining electronic documents
• Strong analytical and problem-solving skills
• Ability to adapt to changing priorities and manage multiple tasks
• Strong interpersonal skills and the ability to build relationships across the organization
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use