19 Oct
Software Compliance & Validation Manager
New Jersey, Princeton 00000 Princeton USA

Vacancy expired!

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At UL, we know why we come to work.:

Thousands of us around the world wake up every day with a common purpose: to make the world a safer, more secure and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society, and we are proud that our culture is centered on integrity, collaboration, inclusion and excellence. UL stands at the forefront of technological advancement, and we are continually challenged to find new ways to foster innovation and positive change. Satisfying? Yes. Exciting? Absolutely!

What youll learn & achieve::

The Head of Compliance and Validation is responsible for ensuring the maintenance of a compliance culture within our Life Science LMS business, 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, quality assurance and infrastructure, to foster a culture of continuous improvement and superior product quality and compliance.

Essential Duties and Responsibilities include (but are not limited to) the following:

  • 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 UL 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 UL 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.

  • Leads/trains cross-functional UL teams in compliance responsibilities and validation activities and helps define regulated, computerized system use.

  • 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 procedures

  • 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.

  • Maintains efficient archives of all validation documentation and supporting evidence for review during onsite client audits.

  • 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.

  • Responsible for ensuring and maintaining GDPR compliance (as well as other state and country specific data integrity and security compliance) for all applicable PURE Learning Products.

  • 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.

  • Responsible for scheduling and facilitating the quarterly Management Review Meetings with all PURE Learning management.
  • Represents the Validation and Compliance Team at company and client meetings and audits when necessary.

  • Effectively sets, forecasts and manages the Compliance & Validation budget.

What makes you a great fit::

  • 7 -10+ year’s 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.

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

  • 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.

  • 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.

What youll experience working at UL::

  • Mission: For UL, corporate and social responsibility isn’t new. Making the world a safer, more secure and sustainable place has been our business model for the last 125 years and is deeply engrained in everything we do.
  • People: Ask any UL employee what they love most about working here, and you’ll almost always hear, “the people.” Going beyond what is possible is the standard at UL. We’re able to deliver the best because we employ the best.

  • Interesting work: Every day is different for us here as we eagerly anticipate the next innovation that our customers’ create. We’re inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world.

  • Grow & achieve: We learn, work and grow together with targeted development, reward and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles.

  • Total Rewards: All employees at UL are eligible for bonus compensation. UL offers a generous 401k matching structure of up to 5% of eligible pay. Additionally, we invest an additional 4% into your retirement saving fund after your first year of continuous employment. We provide Healthcare Reimbursement Accounts and Health Savings Accounts that UL contributes to twice per year! Depending on your role, you can work with your manager on flexible working arrangements. We also provide employees with paid time off including vacation, holiday, sick and volunteer time off.

Learn More::

Working at UL is an exciting journey that twists and turns daily. We thrive in the twists and revel in the turns. This is our every day. This is our normal.

Curious? To learn more about us and the work we do, visit UL.com.

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