Manager, Clinical Quality Assurance
- Employer
- Pharmacyclics, LLC
- Location
- Sunnyvale, CA, United States
- Start date
- Feb 13, 2019
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- Discipline
- Clinical, Clinical Research, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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 :
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
- Conducts internal system/process audits to ensure compliance with company policies/procedures and GCP/GLP or GVP regulations
- Ensures all audit-related corrective and preventive actions are followed up through completion
- Provides expert GCP/GLP or GVP QA advice to Clinical Development, Nonclinical Safety, Drug Safety and Pharmacovigilance, and Analytical 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
Experience:
- 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
Specific Skills/Abilities:
- 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)
#LI-SH18
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Company
Pharmacyclics LLC, a wholly-owned subsidiary of AbbVie (NYSE: ABBV), is focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immunemediated diseases. Pharmacyclics’ mission is to develop and commercialize novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs. Pharmacyclics markets IMBRUVICA and has two product candidates in clinical development and several preclinical molecules in lead optimization. Pharmacyclics is committed to high standards of ethics, scientific rigor and operational efficiency as it moves each of these programs toward commercialization. To learn more, please visit www.pharmacyclics.com.
- Website
- http://www.pharmacyclics.com/
- Mini-site
- Pharmacyclics, LLC
- Phone
- 408-774-0330
- Location
-
995 East Arques Avenue
Sunnyvale
California
94086
US
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