Validation Engineer

PENNEP is seeking a talented and dedicated Head of Compliance and Validation to join our client’s dynamic team. The Head of Compliance and Validation is responsible for ensuring the maintenance of a compliance culture within client, clearly articulating and enforcing throughout the organization the criticality of maintaining compliance with appropriate regulations, including 21 CFR Part 11, EU Annex 11 and our own internal policies, procedures and work instructions. Works in close coordination with all departments, including product management, software development, services, quality assurance and infrastructure, to foster a culture of continuous improvement and superior product quality and compliance.

• Responsible for driving the compliance culture throughout the organization by ensuring adequate training of all employees on appropriate level of understanding regarding compliance with 21 CFR Part 11, EU Annex 11 regulatory requirements and client policies and procedures as well as ensuring actual compliance with those regulations, policies and procedures.
• Keep current with regulatory developments, including GxP, 21 CFR Part 11, EU Annex 11, GAMP, ICH, USP and risk management, corporate policies and procedures, etc. to ensure client meets or exceeds industry best practices for compliance and validation.
• Oversees the validation and compliance management team’s collaboration with other IT members, QA, & business functions on validation of new systems and improvement of existing IT Quality processes/practices.
• Ensures consistent interpretation and implementation of regulatory controls to all projects, regardless of size, scope or location.
• Ensure the proper implementation of SDLC methods as they relate to Computer Systems Validation, IT Quality Systems, and Technology in general.
• Provides computer validation oversight for IT projects to assure compliance with company policies, standard operating procedures and FDA requirements.
• Leads/trains cross-functional teams in compliance responsibilities and validation activities and helps define regulated, computerized system use.
• Lead external client audits and communicate all findings directly to management, as applicable.
• Ensures audit corrective actions and other CAPA’s are followed-up on and implemented.
• Oversees the development of standard operating procedures, strategy and guidance documents as they apply to quality systems, software development and validation processes and procedures.
• Maintains efficient archives of all validation documentation and supporting evidence for review during onsite client audits.
• Responsible for ensuring and maintaining GDPR compliance (as well as other state and country specific data integrity and security compliance) for all applicable client Verification Learning Products.

• 7-10+ years’ experience working in a management/strategic decision-making role related to compliance and validation of computer systems within an FDA regulated environment, or within a SaaS provider whose products target FDA regulated companies and whose products must be able to be validated to be compliant with 21CFR Part 11.
• Expert knowledge of Computer Systems Validation in a life science or regulated environment required.
• Experience with software validation and testing methodologies, documentation and product specifications in an FDA regulated environment such as pharmaceutical, bio-tech or medical device required.
• Knowledgeable in all of the following regulations/regulatory guidelines: 21 CFR Part 11, Electronic Records – Electronic Signatures; General Principles of Software Validation - Final Guidance for Industry and FDA Staff; Good Automated Manufacturing Practices (GAMP) guidelines; or other methodologies for Computer Systems Validation in a regulated environment.
• Minimum of 5 years’ experience hosting client or 3rd party on-site audits and conducting internal audits of various quality sub systems required, including managing organizational responses to client or 3rd party audit reports.
• Ability to manage multiple ongoing projects and deadlines.
• Excellent written and oral communication skills.
• Strong level of detail, problem solving, and organizational skills.

BA/BS degree in a technical field, or equivalent education and experience.

Contract

Hybrid Work