Manager, Clinical Quality Assurance
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 an essential role in the company's Clinical Quality Assurance (CQA) group focused on Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) compliance. The incumbent will perform internal and external GCP, GLP, or GVP audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH guidelines, Pharmacyclics' procedures and protocols. Responsibilities will also include providing guidance to clinical and nonclinical study teams, training of staff, and development/maintenance of GCP/GLP or GVP related quality systems.Key Accountabilities/Core Job Responsibilities:
- Leads or supports the development of GCP/GLP or GVP quality systems and SOPs in compliance with applicable regulatory requirements, and supports department infrastructure development
- Maintains the development of GCP/GLP or GVP audit plans and implementation of the audits necessary to ensure clinical trials and nonclinical studies are conducted in compliance with applicable study protocols, GCP/GLP or GVP, ICH Guidelines, and regulatory requirements
- Conduct audits of clinical study and regulatory submission documents, including, Clinical Study Reports, Trial Master Files, and Safety Reports
- Ensures all audit-related corrective and preventive actions are followed up through completion
- Chemistry based on interpretation of current GCP/GLP or GVP regulations to assure best practices
- Supports the administration of the company's training program and conducts GCP/GLP or GVP training to internal departments and at investigator meetings, if applicable
- Supports the management of contractors/consultants
- Supports regulatory authority inspection readiness activities, inspection support (e.g., front-room, or back-room), and coordination of responses
- Facilitates investigations of GCP/GLP or GVP-related matters
- Reports significant quality deficiencies to CQA management
- Manages the development of metric reports to relevant management
- Facilitates CQA team meetings and discussions, as needed
If this position has direct reports:
- Provide technical guidance and timely performance feedback through routine 1:1 meetings.
- Provide technical development through OTJ training.
- Work with HR to ensure opportunities for professional development.
- Assist with developing individual goals and objectives.
Education and Training (degree, certifications, etc.):
- 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
- 4-8 years of progressive pharmaceutical experience in a clinical/nonclinical development arena
- Minimum of 5 years in GCP/GLP or GVP auditing inclusive of developing quality systems
- Minimum of 1 year exposure of regulatory authority inspections and inspection readiness preferred
- Must be a team player
- Excellent working knowledge of GCP/GLP or GVP -related regulatory requirements and ICH guidelines
- Broad experience in the pharmaceutical industry with a strong clinical development understanding
- Detail-oriented with analytical and problem-solving skills
- Ability to work effectively in a fast-paced environment with initiative and great organization skills
- Ability to deal with ambiguity, creative and pragmatic approach to problem solving.
- Excellent verbal and written communication and interpersonal skills
- Computer system validation (CSV) knowledge is a plus
- Proficient with computers and typical office software (e.g., Microsoft Office products)