Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Specialist, Quality Validation. The position reports to the Director, IT Quality. The location of the position is in Brisbane, CA.
As a member of the GxP Quality teams, the Senior Specialist of QA Validation will be responsible and function as the liaison between, business teams, IT technical teams, and Quality to lead validation projects per computerized systems and validation lifecycle to ensure that it meets regulatory and industry standards and expectations.
The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties and Responsibilities
- Responsible for Myovant validated GxP systems inventory list and maintain systems in validated state
- Function as the Validation lead for the implementation of GMP and GCP computerized Systems for QMS, Serialization, eTMF, CRM, and other CSV projects
- Responsible for validation deliverables for medium-to large-sized CSV projects
- Support IT Infrastructure qualification activities
- Provide technical validation impact assessment for GxP Deviations, Investigations, CAPAs and change controls to ensure activities are conducted in compliance with procedures and regulatory requirements
- Author or review procedures, work instructions and other governing documents including Validation Plans and Summaries, IQ, OQ and PQ, URS, FRS, DS RTM, etc. for the design, validation and deployment to support computerized system lifecycle activities
- Execute validation protocol and test scripts; review executed validation protocol and test scripts
- Assist in continuous improvement projects of validation processes related to management of computerized systems
- Assist in establishing processes related to computer system compliance to regulatory requirements
- Provide training for computerized systems and QA workflows related to such systems
- Own and maintain validation documentation archive process
- Ensure that validated GxP systems and associated documentation are prepared for regulatory inspections related to computerized systems
- Oversee and assist business owners in change control activities related to validated GxP systems
- Participate in compliance audits of existing vendors and due diligence of new vendors as required
- May interface with regulatory agencies as required
- Perform other duties to support department activities (e.g., Document Control and Training) as assigned
Core Competencies, Knowledge, and Skill Requirements
- Knowledge of regulatory requirements pertaining to computerized systems in GxP environments.
- Demonstrates knowledge of Information Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements
- Experience applying risk management principles to computer system validation and IT qualification activities
- Demonstrate understanding of Data Integrity concepts and controls for computerized systems
- Ability to author and review validation documentations and SOPs
- Experience interfacing with regulatory authorities to present validation deliverables during inspections
- Excellent interpersonal skills and ability to develop strong collaborative internal/external relationships
- Sound critical thinking and ability to assess interdependencies when making decisions regarding validation and potential impacts
- Must have excellent customer-service orientation, high degree of professionalism
- Demonstrate a positive, ‘can do’ and service-oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks
- Attention to detail, time management and investigative skills as well as ability to multi-task and shift priorities quickly while working under tight deadlines
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, SharePoint).
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
- At least 4 years of Computerized System validation experience within biopharmaceutical industry in a GXP environment.
- Strong working knowledge of FDA regulations (Part 11, 210/211), global regulations (EU Directives, including Annex 11) and applicable ICH guidelines.
- Knowledge of risk-based validation approaches and continuous process improvement principles.
- Experience working with SaaS delivery model and completion of SaaS validation.
- Attention to detail as well as clear and concise style in written and oral communications.
- Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment.
- Experience with audits and regulatory inspection support is highly desirable.
- Ability to travel both domestic and internationally, as needed.
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).
- Experience with implementation and validation of SaaS platform (Veeva, others).
- Experience with implementation and validation of ERP system (SAP, Oracle, others).
- Experience with GMP and/or GCP operations.
TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
If you require any accommodations, please email firstname.lastname@example.org.
Equal Employment Opportunity