Director, Digital Quality

Ology Bioservices, Inc.
Job Description
Role Ready to join a team dedicated to quality excellence, innovation and the advance of complex medicine manufacturing supporting patients worldwide? Are you an architect at heart and love designing and developing systems and processes from the ground up? We started an incredible journey and are looking for passionate leaders to join us on this important mission.

This role is accountable for participating in the development, implementation and lifecycle management of the Digital Quality and Compliance program and operationalizing it. The Director, Digital Quality is responsible for the quality oversight of computerized systems, automation, instrumentation and data integrity at the Alachua manufacturing facility.

This position reports to the Head of Digital Quality for Automation Systems and is located at the Alachua, FL manufacturing facility.

Job Responsibilities
  • Ensure the Quality and compliance of GXP activities with respect to internal and/or customer procedures as well as FDA, ICH, EU and country specific regulations
  • Provide Quality oversight to Digital Systems (Automation & Laboratory Instrumentation) implementation projects across all phases of the System Development Lifecycle and associated artifacts across a Resilience site (Alachua).
  • Provide Quality oversight to Digital Systems and Cloud Infrastructure implementation projects across all phases of the System Development Lifecycle and associated artifacts across Resilience network as assigned.
  • Serves as a liaison between site functions (including site Quality) and central Digital Quality function.
  • Leads Digital Quality initiatives and program rollout for identified stakeholders.
  • Leads and works with cross functional team to assist in establishing a corporate-wide Digital Systems Governance Program (such as SDLC, Data Integrity, Risk Management and others) and instituting them on sites.
  • Participate in development of a risk management strategy for Data Integrity controls (including testing) of digital systems procured by and/or designed/developed in house at Resilience; collaborate with stakeholders (including sites, franchises) to institutionalize on site.
  • Lead/assist/oversee Digital System / Vendor audits per established risk based strategy at site or network level).
  • Lead/conduct/oversee of training of Resilience personnel on CSV, Change Control, Data Integrity and on relevant Quality SOPs
  • Assist in establishing, and facilitate the Governance boards for Digital Quality at network and site levels.
  • Assists in the development systems strategy that pilots and implements efficient cutting-edge technology on new platforms, including intelligent robotic, automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies at site and central functions.
  • Maintain systems in a state of inspection readiness at all time.
  • Recruits talent (contract and/or full time) as appropriate and builds a high performance team; mentors and coaches personnel.
Qualifications
  • Comprehensive knowledge of global GMP regulatory requirements
  • Hands on experience in developing and managing an effective Computer Systems Quality Assurance program in support of COTS and customized GMP computerized systems to meet Digital needs.
  • Hands-on experience in building and managing team focused on providing quality oversight of computerized systems validation program.
  • Demonstrated experience in assuring data integrity controls are designed and adhered to in Computerized Systems.
  • Excellent oral and written communication skills with strong technical writing experience required
  • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
  • Demonstrated ability to set goals, perform long-term project planning, team building, budgeting and operational excellence
  • Demonstrated ability to successfully execute responsibilities in a fast-pace environment, collaborating across multiple sites and stakeholders
  • Ability to travel domestic and international.
Preferred Experience
  • Bachelor’s degree or higher in IT, Life Sciences, Chemistry, Engineering, or related field
  • Minimum of 15 years of pharmaceutical/biotechnology industry experience, with minimum of 10 years in an IT Compliance/Quality leadership role
Contact Information