Manager, Computer Systems Validation

Location
San Francisco, CA
Posted
Apr 05, 2019
Ref
448
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
MANAGER, COMPUTER SYSTEMS VALIDATION

Position Summary:

This position is responsible for managing all aspects of Computer System Validation activities at GBT.

GBT places a high value on cooperative team dynamics and a positive, "can-do" work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed.

Essential Duties and Responsibilities:
  • Performs and leads CSV projects related to authoring and executing specifications and validation documentation according to the GAMP5 Validation Life Cycle, including: Validation Plan, System Requirement Specification (SRS), Risk Assessments, Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary Reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review
  • Generate validation protocols in line with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations
  • Generate validation plan detailing the scope of work and intent.
  • Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements
  • Ensure all work is in line with the site Master Validation Plan, regulations, procedures and practices
  • Ensure that the site Validation Master Plan remains current and aligned with corporate policies
  • Lead and conduct validation activities in compliance with US and EU regulations (regulations for all countries where have business)
  • Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations
  • Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan
  • Prepare validation summary reports for executed protocols
  • Liaise with other departments (Technical Operations, Clinical Operations, Regulatory Affairs, IT) in execution of the Validation program
  • Communicate Computer System Validation approaches and requirements during audits.
  • Facilitate a continuous improvement culture with other departments at GBT (Technical Operations, Clinical Operations, Regulatory Affairs, IT)
  • Anticipate and assess/prevent technical problems from impacting product and processes
  • Work with Business Owner(s) and System Owner to ensure the validated state of the system with change control activities
  • Manage Computer System Change Control process
  • Track and resolve deviations/exceptions during qualification activities
  • Prioritize qualification activities in line with the project schedules and timelines.
  • Co-ordinate validation/qualification activities with key stakeholders
  • Assist in the development of training material for qualification activities
  • Serve as a Subject Matter Expert to support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork
  • Lead and participate in cross functional teams as defined by the site management team
  • Interpret Regulatory Authority regulations, guidelines and policies
  • Communicate and ensure compliance with Quality objectives, policies and procedures

Qualifications:
  • Bachelor's degree in business/technical area or comparable education/experience.
  • Hands-on experience in CSV in the pharmaceutical industry, or related industry. Title and responsibilities to commensurate with experience. Minimum 5 years of experience
  • In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines
  • Ability to establish clear priorities quickly
  • Ability to work effectively under pressure, handle multiple projects and meet deadlines
  • Ability to lead Computer System Validation projects for the site
  • Ability to write technical documents (Validation plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report etc)
  • Ability to independently identify compliance risks and escalate when necessary
  • Demonstrated leadership in cross-functional and culturally diverse team settings
  • Excellent interpersonal skills with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship
  • Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
  • High energy, enthusiasm and excellent leadership and management skills
  • Strong verbal and written communication skills, good decision-making skills and time management skills is a must; ability to interface with all levels of the organization
  • Knowledge in risk assessment, gap analysis, changes control and deviation management

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.