The incumbent will provide guidance, direction, and oversight for Quintiles Technology Solutions (QTS) Delivery Assurance, comprising SDLC, Process, Validation, and Regulatory related compliance and is responsible for ensuring the overall quality of QTS processes, SDLC artifacts, products, and deliverables. This key individual will act as a subject matter expert on technical matters involving implementation, best practices, and compliance related to software development, SDLC, application and product engineering and support, validation processes and documentation; as well as pre-audit readiness, audits, and CAPAs. The incumbent will be tasked with strategic and operational responsibilities pertaining to QTS Delivery Assurance and Compliance and an integral partner to QTS innovative technology platforms and solutions.
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Lead the strategic development, implementation, application, and continuous improvement of Quintiles TS Delivery Assurance processes and systems meeting both operational and regulatory requirements globally.
Lead Quality and Validation function for QTS, with direct or cross-functional management responsibility for global resources and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity, and business processes in place to maximize the value of QTS Delivery Assurance related processes and systems.
Facilitate effective cross-functional communication, alignment, collaboration, leadership and execution on quality and compliance related objectives, plans, and priorities
Keep abreast of the evolving regulatory policy and industry best practices related Quality and Compliance
Develop business cases for proposed investments and changes in systems, processes, staffing, and organizational development for QTS Delivery Assurance, providing clarity on costs, benefits, alternatives, resource requirements, and other relevant information to enable timely, effective decision making
Provide expert advice to leadership and functional area managers on quality, testing and validation, regulatory, compliance, and documentation related issues, including those with department-wide or external impact
Collaborate with functional areas to establish and update metrics that are reported to leadership that highlights risks and key opportunities for continuous quality improvement
Provide Quality, SDLC, and documentation related input to software product development and project delivery processes to maintain compliance with the relevant regulations and international standards
Provide input and resources to author, review and finalize quality-related documentation.
Identify and suggest functional improvements to the Delivery Assurance related processes and systems.
Partner with teams responsible for Quality and validation software and all other related tools/technologies to support company needs in this area
Support and oversight of corporate CMMI related efforts for QTS including advising project teams on necessary changes to processes, documentation, and associated training
Oversees QTS Quality and Compliance management to ensure internal standards and procedures for Computer System Validation remain effective at delivering compliant IT solutions.
Provides guidance to QTS teams on interpretation and application of procedures applicable to the implementation and operation of IT systems.
Provides regulatory and software quality knowledge and expertise to support high quality application development and deployment while embracing a risk-based approach
Provide leadership and direction to ensure documentation and testing practices meet applicable regulatory requirements, company policies and quality standards, using sound computer system validation and QA testing practices.
Provides oversight and approvals of risk assessments related to IT systems and platforms
Collaborates with corporate Quality and SCO functions for pre-audit and audit planning, support for internal and external audits, and leadership and oversight for potential findings and CAPAs from audits
Works with project managers to establish work scheduling plans in support of project schedules. Provides resource estimates for QA and validation efforts related to project and budgetary planning.
Manages resource allocation to approved projects and ensure project timelines are met.
Monitors new and emerging regulatory requirements and good practice guidance for GxP computerized system, IT controls and compliance
Qualifications
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Bachelor degree in Computer Science, or engineering or related field.
Minimum 12 years of experience in Delivery Assurance or QA leadership and management roles with direct or cross-functional management responsibility for personnel and responsibility for a broad spectrum of Pharma Software Development and/or Solutions and Services Delivery related Quality and Compliance elements
Demonstrated success leading cross-functional development, implementation, application, and maintenance of Delivery Assurance processes and systems
Strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity
Detail-oriented with strong organizational skills and high quality standards
Outstanding written communication skills with experience in authoring both internal and externally facing quality related documents
Good interpersonal and verbal communication skills, with the ability to effectively communicate with employees, functional area and executive management, customers, and business partners
Ability to integrate and apply feedback in a professional manner
Is considered an expert in computerized system lifecycle management and has experience in the application of industry best practices
Well versed with regulatory compliance (GxP, 21CFR Part 11, CMMI, EU Annex 11 etc.)
Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP-5, NIST, ICH
Experience with application of CAPA methodology including structured approach for failure investigation and identification of root cause
Experience in participating in regulatory inspections, presenting/defending IT functions in audits or regulatory inspections
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s Degree in Computer Science or related field; with 12 years IT experience including previous management experience or equivalent combination of education, training and experience
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