Clinical Quality Manager
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.
To learn more about us, please visit us at http://www.pharmacyclics.com/
Pharmacyclics is seeking a Clinical Quality Manager.
General Position Summary / Purpose:
Assists with strategic and tactical development, implementation, execution and management of the Development Operations Clinical Quality Management Program. Leads assigned ongoing GCP compliance activities by Pharmacyclics clinical trial management teams and ensures adherence to applicable GCP regulations and guidance. Assists with the development, implementation, maintenance and training associated with Development Operations SOPs and other work process guidance. Assists with the development of clinical trial quality management plans and process. Assists with the preparation and support for Regulatory Authority GCP inspections. Collaborates with and supports Pharmacyclics Clinical Quality Assurance group as necessary.Key Accountabilities / Core Job Responsibilities:
- Contributor to the Pharmacyclics Quality Management System
- Proficient in risk management principals
- Collaborates with Pharmacyclics Clinical Quality Assurance in the preparation and support of Regulatory Authority GCP inspections
- Assists Development Operations staff with interpretation and application of global GCP regulations
- Assists with clinical trial GCP training to Development Operations staff
- Performs Clinical Quality Management compliance assessments/investigations.
- Assists with the development of new and the monitoring and identification of gaps within Development Operations SOPs and associated documents
- Assists Clinical Operations in formulating responses to observations/findings
- Assists in mentoring of Clinical Quality Management team members
Qualifications / Requirements:
- 5 years' minimum experience in the pharmaceutical/biotech industry or relevant clinical research organization experience, including clinical auditing or monitoring or trial management experience
- Significant knowledge of global clinical trial regulations and guidelines
- Experience in supporting clinical trial GCP compliance and clinical quality management activities
- Experience in supporting Regulatory Authority GCP inspections
- Excellent interpersonal and communication skills (both written and oral)
- Ability to problem solve and delegate appropriate tasks
- Strong leadership skills, self-motivated, adaptable to a dynamic environment
- Proficiency in MS Word, Excel and PowerPoint
- BA/ BS required
- Able and willing to travel up to approximately 25%