Senior Manager, Computer Systems Validation

SENIOR MANAGER, COMPUTER SYSTEM VALIDATION

Job Summary:

Manage all aspects of Computer System Validation activities at Global Blood Therapeutics (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:

• Establish policies and procedures related to Computer System Validation (CSV): Part 11 Compliance and Computer Systems Policy, Electronic Signature and Record Policy, Security Policy, Computer System Change Control, Validation of GxP Computer Systems, Problem Reporting, Risk Assessments, Periodic Review
• Perform and lead CSV projects related to authoring and executing specifications and validation documentation according to the GAMP5 Validation Life Cycle,including: Computer System Validation Plan, System Requirement Specification (SRS), High Level Risk Assessment (HLRA), 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 a CSV validation plan detailing the scope of work and intent
• Identify specific tests and requirements to be met in the IQ/OQ/PQ that address
• 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
• 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 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
• Generate and maintain Computer System Validation procedures in line with corporate guidelines procedures, CGMP, Corporate policies/standards and ISPE GAMP guidelines
• Work with equipment owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures
• Manage Computerized 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
• Manage Validation contractors to complete on-site validation, if required
• Lead and participate in cross functional teams as defined by the site management team
• Must be able to maintain a "big picture" perspective without losing site of the details necessary to meet deliverables and deadlines
• 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 and management experience in CSV in the pharmaceutical industry, or related industry. Minimum 8 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
• Experience with Electronic Data Management Systems
• 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 (like 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 are 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.