IT Risk Management & Compliance Analyst

Job content

Kindeva is a global contract development manufacturing organization focused on drug-device combination products. Kindeva develops and manufactures products across a broad range of complex drug-delivery formats, including injectables (autoinjector, intradermal, microneedle), pulmonary & nasal, and transdermal patches. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K. The company was recently merged Meridian Medical Technologies and is poised for a growth journey. This journey recognizes the need to make strategic investments and expand our IT team.

Kindeva is seeking a qualified candidate that has a passion to deliver the computer system validation and risk management approach to support tremendous IT and business growth. This role is an IT team member part of the ITRMC (IT Risk Management & Compliance), interfacing between the quality business unit, IT, business customers, and vendors on all types of computer system validation projects and compliance initiatives. Over the next 3 years, the business is expected to deploy several, major operational systems like LIMS, ERP, MES, VLMS, EBR to transform our capabilities and deliver improvements to our customers and the patients served. This role will be instrumental in helping achieve those objectives.

Role Responsibilities

• Provides technical and compliance expertise for strategy/execution of computer systems validation in accordance with various regulatory standards or guidance (e.g., 21 CFR Part 11, 211, 820, GAMP, CSA).
• Performs IT change control impact assessments and work with IT and business SMEs
• Represents Kindeva IT in company change control meetings for new/existing IT solutions.
• Develops some parts or all computer system validation project documentation and artifacts.
• Takes the project lead and/or business analyst role for assigned projects and initiatives related to compliance improvements, remediations, and design/build of new compliance processes.
• Runs small to large, simple to complex, computer system validation efforts.
• Provides coaching and guidance to various system and project stakeholders on computer systems validation best practices, risk management, and industry guidance.
• Advises on IT project execution and IT infrastructure operations from a risk and compliance point of view.
• Provides IT audit support for internal and external audit entities (e.g., TGA, FDA, CBOH, MHRA) regarding board of health regulations, standards, and practices
• Stays current on computer systems validation approaches, industry trends, and board of health agency guidance.
• Provides software supplier assessments support to evaluate suppliers for engagement related to IT systems and processes used within the manufacturing and quality plane
• Oversees junior roles, staff augmentation, or vendor services contracted or procured for execution of computer systems validation on larger projects.
• Takes ownership for some or part of IT life cycle compliance operations to ensure periodic activities are completed with quality and on time and systems stay fit for purpose.
• Develops, maintains, or improves controlled IT documents and procedures to align new IT services/operations or to fill operational compliance gaps.

Example Experiences Sought

• Operated as the computer systems validation strategy lead on multiple, complex systems in a biopharma, manufacturing environment.
• Delivered computer system validation packages for IT lab, IT Quality, and IT manufacturing systems as lead validation engineer.
• Designed IT-regulatory compliance processes and operational improvements.
• Performed extensive risk managements and gap-remediation on IT systems and processes to align validation life cycles with board of health agency expectations and industry standards.
• Executed data integrity business programs and/or remediation projects.
• Designed and written every individual artifact or element of a computer systems validation approach and life cycle.
• Executed computer systems validation within an SDLC, iterative framework.
• Worked closely with IT / technical SMEs providing coaching on computer systems validation and compliance operations, changing culture, winning hearts and minds.

Required Qualifications

• Bachelor’s degree in Computer Science, IT, or science-related discipline
• Proficient in English
• Candidate must be a U.S. or UK citizen.
• 8+ years of experience in pharma/device or other pharma regulated industry in IT related support functions – specifically validation of laboratory, quality or manufacturing related IT systems.
• Deep knowledge of lab systems, plant manufacturing systems, quality systems, Document Management Systems, CAPA processes, risk management and audits typical for a pharmaceutical manufacturing operation.
• Clear, sustained experience with SDLC/GAMP and IT project management methodologies; Agile cGMP development is a plus.
• Training and knowledge of FDA CSA a plus.
• Lean Six Sigma and/or ASQ certification a plus.