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Director, Quality Applications

National Resilience

National Resilience

IT, Quality Assurance
Multiple locations
Posted on Saturday, June 1, 2024

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary:

Resilience is ushering in an era of “Biomanufacturing-as-a-Service” that we expect will displace in-house manufacturing as well as traditional contract development and manufacturing organizations (CDMOs). We see this as a paradigm shift in biomanufacturing akin to the IT industry’s adoption of Infrastructure-as-a-Service (IaaS) and Platform-as-a-Service (PaaS) that rendered obsolete corporate-owned/operated data centers or corporate servers co-located in hosting facilities.

The Director, Quality Applications will play a pivotal role in shaping and executing our quality applications technology and strategy. This role will lead the technical design, implementation, and continual improvement of scalable Quality Assurance and Quality Control systems to promote operational excellence. The director will be responsible for blending off-the-shelf software with internally developed technology to deliver the digital solutions to Quality organizations. Candidates should possess a multifaceted background in GxP system development including implementation, training, support, administration and project management. This role also seeks a better way to automate the modern quality operation.

Responsibilities

  • Provide strategic direction for Quality Systems maturity in line with business drivers and company priorities.
  • Lead technical team to ensure all aspects of system development lifecycle and operational support encompassing application performance, stability, end-to-end transactional flows, root cause analysis and corrective actions for any outages.
  • Manage teams implementing multi-functional and multi-location projects.
  • Develop and execute a strategy to establish a common quality systems platform across Resilience network ensuring alignment with business goals and scalability.
  • Lead Management Review to monitor health of Quality Systems and implement continuous improvement.
  • Possess excellent leadership and communication skills, with the ability to effectively collaborate with cross-functional teams and drive alignment towards common goals.
  • Responsible for leading the partnership between leadership and business to better align quality systems roadmap followed by yearly budgeting and fiscal management.
  • Lead through change and support adoption of technology for improved and optimized business processes.
  • Provide direction for the development of prototypes and proof-of-concept demonstrations to address business needs.
  • Work closely with other individuals in the organization to understand business demands and identify appropriate opportunities for solutions and continued innovation of technical capabilities aligning with business needs.
  • Build, develop, and lead a high-performing team, fostering a culture of collaboration, innovation, and professional growth.

Minimum Qualifications:

  • Experience in working with teams involved in development, production support and maintenance of Life Science software systems.
  • Ability to drive collaboration and decision making through the development of a strong team dynamic to foster alignment and commitment to shared goals and responsibilities.
  • Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
  • Track record of successfully working with cross-functional teams – business users, project managers, QA, etc. to build and enhance applications and programs.
  • Technology agnostic. Must possess the ability to adapt, learn and apply the correct technology at the right time and not be biased towards an underlying platform or technology.
  • Exceptional and well-practiced communication (verbal, written, listening), inter-personal skills ensuring the ability to interact with the business, peers, and vendors in a professional manner.
  • Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for result to produce innovation, agility, and velocity to support business-as-usual operations and new project implementation and administration.
  • Strong project management skills with the ability to oversee multiple projects simultaneously with strong problem-solving abilities and critical thinking to overcome project challenges.
  • A proven record of demonstrating a leadership role in successful projects that were delivered on time and on budget.

Preferred Qualifications:

  • Experience with COTS solutions; Veeva, LabVantage LIMS, Novatek/MODA Environmental and Utility Monitoring and Waters Empower.
  • Knowledge of project/demand planning tools (e.g., Jira, Confluence, Smartsheet, etc.)
  • Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice.
  • Knowledge of cGMP, GDP, CSV, GAMP 5, 21CFR Part11 and industry best practices.
  • Knowledge of biopharmaceutical production desirable.
  • Familiarity with the Cloud preferably AWS and key approaches to security and change management/deployment.

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. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $160,000.00 - $227,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.