The Senior Manager, CSV Compliance role should have the ability to work closely and collaborate with various business partners including internal/external IT, QA and Business customers and vendors. In addition, this role will provide QA review/oversight for GxP computer systems used in support of Seattle Genetics GCP, GLP, GPvP and limited GMP activities. This position will perform CSV audits and provide the appropriate level of QA support and validation oversight for validation and maintenance of electronic systems as well as incident/problem management for internal and vendor hosted systems.
* Perform or supports internal and external audits of electronic systems to verify that systems are validated and maintained in a validated state in accordance with Seattle Genetics standards and regulatory requirements such as 21 CFR Part 11, Annex 11, ICH E6 R2, OECD Advisory Document 17, applicable Predicate Rules, etc.
* Provide compliance oversight for the validation and maintenance of electronic systems in accordance with Seattle Genetics computer system validation (CSV) procedures and regulatory requirements
* Review and approve CSV deliverables such as Validation Plans, Requirements, Test Scripts, Trace Matrices, Validation Summary Report, etc. associated with the validation and maintenance of computerized systems
* Review SDLC procedures to ensure that the procedures contain the appropriate controls to ensure that computer systems are in a state of control
* Provide management with updates on projects, health of the CSV process and communicate risk-based escalation issues, when applicable
* Support resolution of CSV deviations/errors and provide compliance oversight to software validation projects
* Assist in the management and/or oversight of other external resources for CSV-related activities
* May write, contribute to or edit, as appropriate, SOPs related to the validation of GxP computer systems and/or the use or administration of the validated system(s)
* May assist in the development of training materials, related to the validation of GxP computer systems and/or the use or administration of validated systems. Works closely with IT and software/system vendor(s) as needed, to ensure user/design materials and test documentation can be leveraged and is acceptable
* Applies knowledge of Cloud-based, SaaS systems, thoroughly interprets CSV regulations, guidelines and GxP practices and meets regulatory compliance and corporate business requirements
* Liaises with IT and other cross-functional business teams to ensure that Seattle Genetics electronic systems for issue management and general IT compliance support
* Up to 30% travel required
* Bachelor's degree in technical, scientific or other relevant academic discipline and a minimum of 6 years of experience in a pharmaceutical, biotechnology or related environment combined with a minimum of 3 years of experience in audits and oversight of GxP Computer System validation or equivalent experience and/or education
* Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or regulatory authority regulations and guidances related to CSV (such as, GCP, GPvP, GLP, GMP, GAMP, Part 11, Annex 11, ICH E6, OECD, etc.) activities and compliance
* Demonstrated ability to lead and perform computer system QA audits and oversight of validation activities
* Ability to influence without direct authority
* Excellent verbal and written communication and skills
* Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
* Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
* Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
* Knowledge of word-processing, spreadsheet, and database applications
* Extensive knowledge of pharmaceutical research and development processes and regulatory environments
* Considerable knowledge of quality assurance processes and procedures
* Strong interpersonal skills
Additional Preferred Experience:
Experience with Argus, CTMS, SoftMax Pro, RIM and other GCP, GPvP and GLP systems implementation
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
About Seattle Genetics
Seattle Genetics is dedicated to improving patient outcomes through advanced antibody-drug conjugate technology designed to deliver cell-killing agents directly to tumor cells.