Associate Director, IT Quality Engineering
- Employer
- Pharmacyclics, LLC
- Location
- Sunnyvale, CA, United States
- Start date
- Jul 17, 2019
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- Discipline
- Quality, Quality Control
- 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.
The Associate Director, IT Quality Engineering is responsible for developing and implementing Pharmacyclics strategy for ensuring Computerized systems, applications and Infrastructure used in support of Clinical, Laboratory, R&D, Commercial, Manufacturing, Engineering operations are validated and qualified following established policy and procedures in-line with Industry best practices and using a Risk based approach. The Associate Director Quality Engineering will provide guidance and oversight of processes related to cGMP such as IT Infrastructure Software and Hardware systems commissioning and Applications validation, Qualification and Validation, Computer System Configuration Management and Computer System Validation (CSV). With focus on local as well as regional and enterprise systems, the incumbent will ensure compliance with Pharmacyclics and AbbVie corporate policies and procedures including applicable regulatory guidelines.
Key Accountabilities / Core Job Responsibilities:
- Lead and provide clear directions with design considerations for more complex validation and Qualification projects that may involve multiple technical teams
- Lead and manage a team of Quality Engineering subject matter experts in authoring and revising SOP and Validation deliverables for both GXP and Non-GXP Systems and Applications.
- Monitors resources and budget for Software Quality testing and validation activities.
- Provide leadership and direction in the identification of risks and the development of mitigation strategies for Computer systems validation and qualification projects.
- Manage project teams to provide assurance that requirements, design, and other project deliverables meet standards as appropriate.
- Drives test execution and status reporting including testing automation tools (e.g. HP ALM) to reduce paper-based testing approaches.
- Manages and monitors defect reports and works with developers and other project team members to verify resolution.
- Oversee the deliverables of managed service provider of testing services
- Provide testing strategies for GAMP hardware and software using a Risk based approach.
- Consult on and provide strategies for performing Risk assessments
- Oversee computer system validation and IT Infrastructure Qualification including Cloud based applications and Infrastructure platforms.
- Provide oversight of the change control technical assessment/evaluation process and manage escalation of changes beyond site.
- Align on change control requirements to manage the requested change in consultation with Quality Assurance.
- Support regulatory inspections and audits (internal and external) of Computerized systems and IT Infrastructure.
- Review and approve proposed changes to systems and procedures, as appropriate.
- Review and approve protocols and summary reports.
- Develop, collect, track, review and report metric information for use in continuous improvement of areas of responsibility.
Qualifications and Requirements:
- Bachelor's or master's degree in technical discipline (Computer Science/Engineering or similar Life Sciences).
- 12+ years of relevant industry experience, including 5+ years in a leadership role with related experience in Quality Engineering with related experience such as Computer System Validation in an FDA regulated and GMP environment
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10).
- Minimum 5 years of Team management/leadership experience, preferred.
- Experience in the medical and/or pharmaceutical industry required.
- Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.
- Proficiency in Computer System Validation in a GMP environment.
- Experience with using Test Automation tools like HPALM, equipment and utility IQ/OQ/PQ/PV.
- Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
- Strong knowledge of GMP, GAMP, SOPs and quality systems.
- Experience with internal and external audit principles.
- Strong knowledge of change control and CAPA practices/strategies.
#Li-SH01
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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