Associate Director, Clinical Quality Assurance

Location
Sunnyvale, CA
Posted
Feb 15, 2018
Ref
2280
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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:

This position will play a leadership role in establishing the company's Clinical Quality Assurance (CQA) program focused on conducting internal and external Good Clinical Practice (GCP), Good Laboratory Practice (GLP) or Good Pharmacovigilance Practice (GVP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH guidelines, Pharmacyclics procedures and protocols. The incumbent is also responsible for developing internal and external auditing plans and activities, training of staff as needed, and development/maintenance of GCP/GLP/GVP related quality systems.

Key Accountabilities/Core Job Responsibilities:

    Develops GCP/GLP/GVP quality systems Independently initiates and manages the review and approval of SOPs in compliance with applicable regulatory requirements, and supports department infrastructure development Leads the establishment of CQA audit plans and implementation of the actions necessary to ensure clinical trials are conducted in compliance with applicable study protocols, GCP, GLP, GVP, ICH Guidelines and regulatory requirements Leads and trains others to conduct compliance audits of US and international Investigator sites and GCP/GLP/GVP vendors or partners in accordance with audit plans Leads and trains others to conduct audits of clinical study and regulatory submission documents, including Investigator Brochures, Clinical Protocols and Study Reports, Case Report Forms, Informed Consents, Trial Master Files, and Integrated Safety/Efficacy Summaries Leads and trains others to conduct internal system/process audits to ensure compliance with company policies and procedures, GCP/GLP/GVP guidance and regulatory requirements Ensures all audits are followed-up, corrective and preventive actions are completed, implemented, and verified Provides expert GCP/GLP/GVP QA advice to Clinical Development based on analysis and interpretation of updates to GCP/GLP/GVP regulations to assure best Clinical/QA practices
Externally, if applicable

Manages contractors/consultants, and may manage other CQA employees Leads and train others with investigations of GCP/ GLP/ GVP-related matters Reports significant quality deficiencies to CQA management, and proposes solutions Hosts Regulatory Authority Inspections and ensures inspection readiness Prepares and presents quality metric reports to CQA management, and defines and develops action plans to correct negative trends Facilitates CQA team meetings and proactively lead quality topics and discussion If this position has direct reports:

Provides technical guidance and timely performance feedback through routine 1:1 meetings. Provides technical development through OTJ training. Works with HR to ensure opportunities for professional development. Assists with developing individual goals and objectives. Education and Training (degrees, certifications):

    Minimum BS/BA degree in biological sciences, chemistry, or related field. Society of Quality Assurance Registered Quality Assurance Professional in GCP and/or GLP preferred
Experience:

    10 -12 years of progressive pharmaceutical/biotechnology experience in a clinical/nonclinical development arena Minimum 8 years direct US and International Clinical QA auditing experience, inclusive of developing quality systems and supporting regulatory authority inspections Minimum 3 years of exposure to regulatory authority inspections and inspection readiness activities preferred
Specific Skills/Abilities

    Excellent working knowledge and understanding of GCP/GLP or GVP-related requirements, proficiency of regulatory and ICH guidelines. Broad experience in the pharmaceutical industry with a strong clinical development background Detail oriented with QA and/or Clinical Development background with analytical and problem solving skills Excellent verbal and written communication skills, ability to work well in teams or independently, and ability to prioritize work, manage multiple projects while maintaining quality and advocate for compliance Proficient with computers and word processing software (i.e., Microsoft Office products) Computer system validation (CSV) knowledge is a plus Uses expertise or unique knowledge and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways Ability to deal with ambiguity, creative and pragmatic approach to problem solving
Must be able to travel 25%

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