Associate Director, Digital Quality

Resilience.com

Boston, MA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 04/05/2021
  • Website: resilience.com
  • Company Address:

About Resilience.com

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.

Job Description

RESILIENCE 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.

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 assisting in the development, implementation and lifecycle management of the Digital Quality and Compliance program and operationalizing it.  The Associate Director, Digital Quality is a key leadership role and reports to the Head of Digital Quality.  The position will be located at one of our Resilience network offices.

 

Responsibilities

  • Ensure the quality and compliance of GMP activities with respect to internal and/or customer procedures as well as FDA, ICH, EU and country specific regulations
  • Provide Quality oversight to COTS Digital Systems implementation projects across all phases of the System Development Lifecycle and associated artifacts across Resilience network.
  • Support initiatives and projects to establish a corporate-wide Digital Systems Governance Program (development and lifecycle management of policies and standards in support of deployment and maintenance of computerized systems).
  • Support development of a risk management strategy for DI controls (including testing) of digital systems procured by and/or designed/developed in house at Resilience; collaborate with stakeholders (including sites, franchises) to institutionalize the strategy across the Resilience network.
  • Prepare and conduct or assist/oversee Digital System / Vendor audits per established risk based strategy.
  • 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 such as Computer Systems Validation and/or Change Review Board.
  • Establish and manage the GXP applicability and risk profile determination of GXP systems procured and designed/developed within Resilience.
  • Assist in developing 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
  • Maintain systems in a state of inspection readiness at all time.
  • Contribute to the development and implementation of the global digital compliance strategy

 

Qualifications

  • Comprehensive knowledge of global GMP regulatory requirements
  • Hands on experience in developing and managing an effective Computer Systems Assurance program in support of COTs and 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

 

Requirements

  • Bachelor’s degree or higher in IT, Life Sciences, Chemistry, Engineering, or related field
  • Minimum of 12 years of pharmaceutical/biotechnology industry experience, with minimum of 5 years in an IT Compliance/Quality leadership role

 

COVID 19 Alert – Resilience is closely monitoring the Coronavirus Disease (COVID-19). With a focus on candidate and employee safety, we have implemented a temporary process change shifting all in person interviews to be conducted virtually until further notice. 

Equal Opportunity Statement

At Resilience, we believe that the business of business is to improve the state of our world. Each of us has a responsibility to drive Equality in our communities and workplaces. We are committed to creating a workforce that reflects society through inclusive programs and initiatives such as equal pay, inclusive benefits, and more. Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance. Resilience welcomes all.

Resilience does not accept unsolicited headhunter and agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.