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:

The Senior Clinical QA Specialist supports the Clinical Quality Assurance (CQA) management in developing its clinical quality systems/procedures and ensuring quality oversight. Activities will cover all aspects of clinical studies and will require a focus on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Pharmacovigilance (PV) regulations and guidances.

Key Accountabilities/Core Job Responsibilities:

• Contribute to strategic Clinical QA planning and risk assessment
• Develop CQA plans and implements the actions necessary to ensure clinical trials are conducted in accordance with the audit plan, GCP guidelines and regulatory requirements
• Lead and co-audit US and international sites, internal/external systems and vendors
• Ensure all audits are followed-up and corrective actions are completed, implemented, and verified
• Conduct investigations of GCP-related issues (i.e., product complaints) and develop corrective action plans
• Manage CQA quality systems and support department infrastructure development; assist with creation/revision of appropriate CQA SOPs
• Provide GCP guidance to internal departments for all phases of clinical drug development
• Promote/advance quality awareness throughout the organization; coordinate and provide GCP training
• Work in collaboration with clinical sites, Clinical Operations, Regulatory Affairs and other stakeholders to ensure compliance with GCPs and to maintain inspection readiness
• Review regulatory submission documents (Clinical Study Report and Integrated Safety/Efficacy Summaries) and other essential documents (Protocol, Informed Consent Form, and Trial Master Files)
• Develop metric reports for CQA management of all issues related to the outcome of the audits
• Participate and represent CQA in clinical team meetings and discussions as needed

Education Requirements:

• Minimum BA/BS degree preferably in biological sciences, pharmacy, or related field

Experience:

• 5+ years of pharmaceutical experience , preferably in Quality Assurance or a clinical setting
• 1+ years direct US and international Clinical QA auditing experience, preferably with GLP/ PV QA experience

Specific Skills/Abilities:

• Excellent working knowledge of GCP-related requirements, proficiency of regulatory and ICH guidelines
• Broad experience in the pharmaceutical industry with a strong clinical development background
• Detail oriented with Quality Assurance and/or Clinical Development background with analytical and problem solving skills
• Ability to work effectively in a fast-paced environment with initiative and great organization skills
• Ability to analyze and reconcile moderate-to-complex GCP compliance issues independently and in a group setting
• Experience with GLP and PV QA a plus
• Must be a team player
• Excellent verbal/written communication and interpersonal skills

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Equal Opportunity Employer Minorities/Women/Veterans/Disabled