Senior IT Quality Engineer
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:
The Sr. IT Quality Engineer will use a risk-based approach to ensure Computerized systems meets GxP Quality standards and regulatory requirements. This role will provide oversight for GxP software quality and validation activities and the enforcement of applicable standard operating procedures. This position will also drive the creation of Change Control, Deviation and CAPA records as needed to fulfill the goal of business units. This opportunity allows individual contributor to support compliant delivery of the next generation IT technology.Key Accountabilities/Core Job Responsibilities:
- Lead requirements gathering efforts and translate Business Requirements into system Functional, non-functional, and operational requirements.
- Enables the assessment and evaluation of GxP systems by collaborating with System Owners and Business Owners.
- Conducts risk assessment and applies relevant methodologies and tools for GxP applications.
- Responsible for identification of risks and the development of mitigation strategies for GxP applications.
- Drives and coordinates GxP systems related Deviation, CAPA and Change records and ensures appropriate failure investigations and identification of root cause analysis is followed.
- Develop and document Validation Plan; Installation, Operational and Performance Qualification protocols and reports; Standard Operating Procedures; Requirements Traceability Matrix;
- Participate in the development and management of validation deliverables, using risk-based approach to determine testing, documentation, and verification activities, with appropriate justification of the approach.
- Collaborate with Pharmacyclics Quality and Compliance unit staffs to ensure system validation deliverables are developed and executed on time and compliant to company and industry best practices.
- Collaborate with vendor(s), quality, and technical individuals throughout project in generation of required project / validation deliverables.
- Oversee execution of validation protocols for GxP impacting systems. Also lead/coordinate investigations into failures to meet acceptance criteria and determine appropriate corrective actions.
- Support the development, expansion and improvement of SOP, Work Instructions, and related templates for GxP regulated System Life Cycle processes and Data Integrity procedures.
- Communicate status, solutions, and concerns. Disseminate information in a timely manner within the team. Facilitate and address issues within project.
- Manage and monitors defect reports and works with system stakeholders to verify resolution.
- Supports project teams to provide assurance that requirements, design, and other project deliverables meet standards as appropriate.
- Contribute to operational and process improvement initiatives related to IT Quality and Compliance.
Qualifications and Requirements:
- 7-10 years minimum experience in the Information Technology field.
- 5+ years of working in Bio-Tech/Bio-Pharmaceutical Industry .
- Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, GAMP and other applicable standards.
- Demonstrated experience with the implementation or oversight of validated systems in the pharmaceutical industry.
- Experience with SOP authoring relative to regulated computerized systems.
- Excellent verbal and written communication skills.
- Ability to organize and present ideas in a convincing and compelling manner.
- Ability to troubleshoot issues and work independently with minimal direction.
- Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills.
- Bachelor's degree in business, computer science or related discipline.