Head of Compliance and Validation

US-NJ-Princeton
Job ID
2017-6780
# of Openings
1
Job Category
Quality

Overview

Contribute to a Safer, More Secure, and More Sustainable World. At UL, we know why we come to work.  Thousands of us around the world wake up every day with one common purpose - to make the world a safer, more secure, and more sustainable place to live.  We clear the way for our customers to introduce the latest products, technological advances, and systems in an increasingly complex world so they can provide peace of mind to the market.  Our integrity is woven throughout our company and shapes the way we approach and deliver our solutions.  We are proud that the work we do every day has a meaningful contribution to society.  We continue to build upon our legacy of trusted expertise and partnership to keep our communities safe and secure as we march forward into the future.  This helps us sleep better at night, and we are confident that the millions of people we touch rest easier too.

 

UL Compliance To Performance helps our life sciences clients drive results in compliance, quality and performance so they can enter new markets, stay in those markets and grow. We provide complete solutions to business challenges, addressing processes, people and IT issues.  Our solutions are made of advisory, software and learning services, and support client needs from the early stages of market entry, through scale up and optimizing business performance.

 

Our Head of Compliance and Validation is responsible for ensuring the maintenance of a compliance culture within UL Compliance To Performance (UL CTP), clearly articulating and enforcing throughout the organization the criticality of maintaining compliance with appropriate regulations, including 21 CFR Part 11 and our own internal SOPs, guidance, etc.   Working with all departments, including product management, software development, quality assurance and infrastructure they are responsible for ensuring the compliance of all software products with all appropriate external regulations and UL CTP established policies and procedures.

Responsibilities

  • 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 regulatory requirements and UL CTP policies and procedures as well as ensuring actual compliance with those regulations, policies and procedures.
  • Ensure the organization has the appropriate staffing resources necessary to drive quality throughout the organization.
  • Keep current with regulatory developments, including GxP, 21 CFR Part 11, GAMP, ICH, USP and risk management, corporate requirements, system acquisitions, audit findings, CAPA responses and technical progress in computerized systems to ensure UL CTP meets or exceeds industry best practices.
  • 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.
  • Implements proper 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.
  • Defines and implements global quality systems in support of computer validation at the enterprise, business unit and site levels.
  • Lead external client audits and communicate all findings directly to Senior Management as applicable.
  • Ensures audit corrective actions and other CAPAs 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 project specific requirements.
  • Reviews and approves validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including validation plans, requirements and specifications, risk and gap assessments, test plans, qualification protocols, phase reports and summary reports.
  • Ensures all deliverable documents for product releases are created or updated according to release schedule.
  • Works closely with cross-departmental project team members to achieve project milestones and deadlines.
  • Maintains efficient archives of all validation documentation and supporting evidence for review during onsite client audits.
  • Helps coordinate testing efforts with the Software Quality Assurance Manager – Testing in order to meet all projected deadlines.
  • Provides guidance to team of Quality Assurance Analysts through the testing and validation documentation of UL CTP’s products.
  • Ensures organizational compliance with regulations of 21 CFR Part 11 and that all testing is executed and documented within compliance levels of our current Standard Operating Procedures (SOPs) and processes.
  • Attends cross-departmental product/project meetings, e.g. functional requirement reviews, risk log reviews, etc.
  • Provides continuing education and consultation throughout organization on 21 CFR Part 11 and other regulatory requirements as needed.
  • Drives the development and enforcement and compliance to SOPs company-wide.
  • Creates, implements and refines a Quality Management System (QMS) – including Change Control, Corrective Action Preventive Action (CAPA), Internal Audits, Management Review Meetings, QA Metrics, etc.
  • Executes internal audits (or coordinate with 3rd party if required). Ensure corrective actions are addressed and verify compliance.
  • Promotes and encourages process improvement throughout the organization to meet Quality System requirements.
  • Reports on Quality System activities at Management Review Meetings with senior management.
  • Represents the Validation and Compliance Team at company and client meetings and audits when necessary.
  • Interviews potential hires. Assists in the training of new personnel. Conductss employee performance reviews based on Human Resources (HR) guidelines.
  • Completes projects as scheduled and within budget.
  • Organizes internal and external resources in an efficient and cost-effective manner.
  • Maintains comprehensive communication, written and oral, with project teams, clients, and senior management when needed.

Qualifications

  • 7 -10+ years experience working  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 (strongly preferred) or in a management/strategic decision-making role related to compliance and validation of computer systems within an FDA regulated environment.
  • 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.
  • BA/BS degree in a technical field, or equivalent education and experience.
  • 3- 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.
  • Experience with budgets and project management a plus.
  • Ability to manage multiple ongoing projects and deadlines.
  • Excellent written and oral communication skills.
  • Strong level of detail, problem solving, and organizational skills.

Grow and Achieve. Growth and development are part of our DNA.  Our working environment is a launch pad for our employees to excel.  Your growth will be supported with targeted development, rewards and recognition programs, so that you can maximize your potential. 

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