Associate Director, IT Quality and Compliance

Description

We are seeking an experienced electronic systems compliance professional to join our dynamic and collaborative team. This is an opportunity to participate and make a positive difference in a growing, fast-paced clinical stage company. In this role, you will be responsible for oversight of all GxP-Regulated Computerized Systems at all phases of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This individual will oversee planning, authoring, implementation and maintenance of computerized system validation packages for business systems used to support regulated activities (i.e. GxP). The ideal candidate will have enterprise-level, hosted-application validation experience.

The AD, IT Quality and Compliance will collaborate with IT, business function, and Quality staff to develop consistent validation strategies, implement and improve standards for IT change management and collaborate with the IT leadership to define resource allocation and validation timelines.

The AD, IT Quality and Compliance will also implement and maintain a program for robust oversight of electronic systems vendors, including system identification and validation status tracking to ensure inspection readiness.

Responsibilities

• Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
• Manage a team of internal and contract CSV personnel (onsite and offshore), including but not limited to assigning projects, obtaining status reports, providing guidance and approving timesheets.
• Work with QA to investigate system issues and perform root cause analysis and implement solutions.
• Develop and enhance the Arcus validation program to ensure alignment with regulatory expectations.
• Support enterprise, cross functional computer systems validation activities, in providing approach, methodology and deliverables in compliance with GxP, 21 CFR Part 11, Annex 11 and Data Integrity principles.
• Support the change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state.
• Ensure timely, efficient, and effective communication and/or interaction with internal GxP partners and external contract providers.
• Perform and maintain the periodic review system to assure computerized systems are maintained in a validated state and in compliance with applicable regulations and SOPs.
• Perform Gap Assessments and Remediation activities as needed.
• Implement and maintain a program for robust oversight of electronic systems vendors, including system identification and validation status tracking to ensure inspection readiness.
• Support external contract provider audits as CSV subject matter expert.

Qualifications

• Bachelor of Science Degree in Computer Science, Life Sciences, Engineering or similar discipline.
• 12+ years of experience in electronic systems compliance / computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
• Previous team oversight and management of FTE/contractors  
• Advanced knowledge of GxP regulations and approaches to System Life Cycles (SLC) and GAMP
• Experience supporting external contract provider audits

• Excellent written and oral communication skills.
• Strong planning, organizing, and execution skills.
• Ability to proactively manage workload and meet deadlines.
• Develop and implement creative solutions to improve processes
• Experience validating Quality, Regulatory and/or Clinical systems a plus
• Experience validating Veeva Vault applications a plus 
• ASQ certification such as CQE/ CQM a plus