Job Title: Manager, Quality Assurance

Description:

Pharmacyclics, Inc. is a pharmaceutical company leveraging our expertise in small-molecule chemistry and drug development to develop therapeutic products in oncology and immune mediated diseases based on novel targets, pathways, and mechanisms. Our pharmaceutical agents are synthetic small molecules designed to target key biochemical pathways in diseased cells. This position is responsible for drug substances and drug products ranging in development from preclinical studies through Phase III clinical trials. Acts as the primary QA interface for Pharmacyclics with drug substance and drug product contract manufactures. This position will also work closely with the clinical department to ensure clinical site GCP compliance. This position will report to the Vice President Chemical Operations.

Responsibilities:

• Perform GLP, GCP and GMP audits
• Review data obtained during all quality activities to ensure consistency with company policies, procedures and specifications
• Maintain and improve the Drug Quality System
• Perform annual GXP training
• Maintain Document Control
• Conduct Drug Specifications Committee and Drug Material Review Board meetings
• Primary contact during Regulatory Inspections
• Assure compliance of test methods and products per FDA/ICH requirements
• Frequently interacts and cooperates with interdepartmental management and outside contractors to assure quality of products and operations
• Prepare the quality department budget

Supervisory Responsibilities:

This position will require supervising one or more employees.

Job Requirements:

Experience:

• Experience in the pharmaceutical industry that includes active participation in the development of one or more drugs through the IND/NDA process.
• Working knowledge with the rules and regulations governing drugs and medical devices.
• Ability to analyze and interpret regulations, specifications, test methods and procedures. Must be able to read, interpret and apply applicable local, state, and federal regulations.

Education:

• BA/BS/MS degree in microbiology, chemistry, or biochemistry and at least 5 years experience in Quality Assurance.

Skills:

• Auditing process for GXP vendors; drug manufacturing sites, clinical trial facilities.
• Excellent proficiency in oral and written communication skills is required.
• Computer skills to include Word, Excel and Power Point.