Director, Quality Risk Management

Resilience
$175,000.00 - $235,000.00
paid holidays, tuition reimbursement, flex time, 401(k)
United States
June 08, 2023
General Company Description Resilience (Resilience US, 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 . Position Summary & Role The Director, of Quality Risk Management, leads the implementation and maintenance of the Quality Management System specifically QRM with the goal of maximizing efficiency, effectiveness, and compliance with all applicable GMP regulations. The successful candidate will develop & maintain a systematic Quality Risk Management program for key risks across clinical development and commercial manufacturing including identification & prioritization of risks and mitigation plans. Job Responsibilities Leads the implementation and maintenance of the Quality Management System specifically QRM with the goal of maximizing efficiency, effectiveness, and compliance with all applicable GMP regulations Develop & maintain a systematic Quality Risk Management program for key risks across clinical development and commercial manufacturing including identification & prioritization of risks and mitigation plans. Promote the development of a quality culture framework & standards including the embedding of risk management principles. Lead and facilitate implementation of quality improvements and ensure business-critical quality improvements are adequately resourced to deliver. Participates in the Resilience network Communities of Practice for Quality Systems and drives continuous improvement Fosters a quality culture that values innovation, continuous improvement, and personal accountability Develops and manages departmental goals and corresponding budget in alignment with corporate vision and goals Recruits talent and builds a high-performance team; mentors and coaches personnel Senior global quality leader to set and execute global Quality Risk Management strategy with input from relevant business partners and management. This will include developing strategy documents (policies and guidance) as well as writing detailed processes and procedures. Directs the strategy for design, deployment, and continuous improvement of the global and local Quality Risk Management Program including the company's risk register. Participate with both internal and external audits to ensure compliance with current regulations. Work closely with training groups to assist in the continual development of and use of relevant tools for Risk Management. Builds and promotes a culture of Operational Excellence within the Quality Unit. Supports regulatory inspections as necessary. Preferred Experience, Education & Qualifications Bachelor's degree in a scientific discipline Comprehensive knowledge of global GMP regulatory requirements for biotechnology products Recruits talent and builds a high-performance; mentors and coaches personnel Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders Deep understanding of the PhRMA code regulations, standards, and business requirements Experience in crafting and implementing quality systems and risk management tools Minimum Qualifications Ten (10) years of pharmaceutical industry experience Five (5) years in a Quality System leadership role Experience within the biotechnology industry Hands-on experience with implementation and/or lifecycle management of Document Management Systems, Learning Management Systems and Quality Management Systems is required Experience with implementing and managing an effective site Risk Management programs is required Experience with managing and hosting audits and regulatory inspections is required Excellent oral and written communication skills with strong technical writing experience are required 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 annualized base pay hiring range for this position is $175,000.00 - $235,000.00. 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.