Senior Clinical Quality Assurance Specialist
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer
General Position Summary/Purpose:Executes and maintains compliant, efficient internal quality systems and procedures related to the manufacture, packaging, testing, and disposition of drug substances and drug products at CMOs. Quality systems include, but are not limited to: Annual Product Review, Product Complaints, Vendor Management, Quality Metrics, Management Review, Change Control, Investigations/CAPAs, and Validations. Key Accountabilities/Core Job Responsibilities: Independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of clinical and commercial drug substances and drug products in compliance with all applicable requirements. Independently reviews and approves executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports related to production and disposition. Performs Quality investigations. Reviews and approves change control requests to ensure compliance with all applicable requirements. Representative on internal CMC team. Participates in or leads internal audit and vendor management programs. Prepares quality metrics. Initiates SOP updates and creation of new SOPs. Quality representative for regulatory inspections. Assists in establishment of Quality-specific documents (e.g., Quality Risk Management Plan, Quality Agreements, Site Master File, and Validation Master Plan). Ensures Quality processes at PCYC and across the supply chain comply with all applicable regulations and guidelines. Education and Training: (degree, certifications, etc.) Minimum BA/BS degree preferably in a scientific discipline. Experience: 2-6 years of pharmaceutical experience in a GMP environment. Specific Skills/Abilities Excellent working knowledge of Quality Systems, GMP-related requirements and ICH guidelines. Experience in the pharmaceutical industry with a strong analytical and/or manufacturing background. Detail oriented with solid problem solving acumen. Ability to work effectively in a team environment with great organization skills. Ability to independently analyze and reconcile moderate to complex issues. Must have demonstrated initiative and accountability in a fast paced environment. Must demonstrate leadership skills through example. Excellent verbal and written communication and interpersonal skills. Proficient with computers and word processing software (i.e., Microsoft Office products