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Head of Digital Quality

Employer
Resilience
Location
Working from Home
Start date
May 12, 2022

View more

Discipline
Information Technology, Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Job Details

RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

For more information, visit www.resilience.com.

The Role

The Head of Digital Quality is a critical leader in the Quality function and report to the Chief Quality Officer. This leader is accountable for the development and lifecycle management of the Digital Quality Assurance program and related processes, providing quality oversight of digital systems and computer system validation, and ensuring a robust and compliant Data Integrity program across the entire Resilience network. The position will be located at one of our network offices or remote location.

Job Responsibilities

  • Accountable for the quality oversight during the development and execution of computer software assurance and validation programs to ensure global regulatory requirements are achieved across all GxP digital solutions and technologies

  • Promotes a strong Quality Culture to ensure digital operations are executed with a quality mindset that is fundamental to ensuring the fit for intended use and highest level of Data Integrity

  • Acts as key thought leader on IT related quality and compliance matters across the entire Resilience network

  • Accountable for assuring the Data Integrity standards are measured and met across the Resiliene network. Oversees the continuous improvement of Data Integrity standards to assure the completeness, consistency and accuracy of GxP data, in alignment with regulatory requirements. Provides guidance to Resilience sites for remediation of deficiencies, as required.

  • Provides thought leadership on the application of Agile software development and implementation methodologies, infrastructure as code and continuous integration and deployment concepts in a GxP environment

  • Serves as a Quality lead on complex, strategic and mission-critical initiatives from inception through delivery across the Digital (IT) eco-systems. These include quality oversight on major capital projects, cloud migration, qualification and validation of GxP systems, and adoption of the Resilience Digital Platform that brings novel digital capabilities across all modalities.

  • Enhances Governance framework(s) to align with the Digital Operations, Security and Product strategy across the Resilience network

  • Collaborates with the Digital, Technical Operations and Quality leads across sites and enterprise in the development and implementation of the global digital quality strategy by assessing risk, driving clarity, and fostering shared understanding

  • Partners with key stakeholders and provides strategic quality and compliance guidance during the selection and implementation of technology platforms (robotics, automation, business analytics, complex manufacturing and testing instrumentation, software testing and automation tool selection, industrial internet of things (IIoT), artificial intelligence (AI) and machine learning (ML) tools, etc.)

  • Supports inspection readiness plans and interacts with regulatory agencies during inspections on computerized systems and data integrity related matters

  • Develops and manages departmental objectives and corresponding budget in alignment with corporate vision and goals; and

  • Recruits talent and builds a high performance team; mentors and coaches personnel.

Qualifications

  • Comprehensive knowledge of global GxP regulatory requirements

  • Hands-on experience with managing IT compliance and providing quality oversight of computerized systems validation

  • Demonstrated experience in leading Quality oversight of Digital Systems in the Cloud (SaaS, PaaS, IaaS) based applications and platforms

  • Experience in providing Quality and compliance guidance on approaches to security and change management/deployment (e.g. Infrastructure-as-Code) for GxP workloads in the cloud

  • Demonstrated experience with quality oversight for implementation of technology platforms / systems such as robotics, bio-manufacturing automation, business analytics, complex manufacturing and testing instrumentation, software testing and automation tool selection, industrial internet of things (IIoT), artificial intelligence (AI) and machine learning (ML) tools, etc.

  • Demonstrated experience with implementing systems and processes to assure data integrity

  • 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

  • Proven success with executing responsibilities in a fast-pace environment, collaborating across multiple sites and stakeholders

  • Capable of leading multiple competing priorities and projects in a fast-paced environment with a proven track record for delivering results on large, cross-functional, global projects; and

  • Ability to travel.

Preferred Experience

  • Bachelor’s degree or higher in IT, Life Sciences, Engineering, or related field

  • Minimum of 20 years of pharmaceutical/biotechnology industry experience, with minimum of 10 years in an IT Compliance/Quality leadership role

#NRI2022

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Company info
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States

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