Director, QMS & Compliance

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

The Director Quality Management Systems (QMS) and Compliance is responsible for the development, implementation and sustaining the QMS and the global business processes for Deviations, CAPAs, Change Controls and Quality Risk Management (QRM) to ensure the internal and external processes meet client, government, and health authority requirements.

This role requires strategic expertise for program ownership, leading governance activities, quality performance monitoring and trending efforts, as well as participating in risk management processes. The role requires a strong, collaborative partnership with cross-functional and inter-company team members to enable strategies for QMS to align with the businesses’ vision. The position will be located at one of our network offices or remote location, that may require flexibility to work at Resilience locations on occasion, to support business needs.

Job Responsibilities

• Global quality leader to set and execute global QMS strategy with input from relevant business partners, sites, and management. This will include developing strategy documents (policies and guidance) as well as writing and maintaining detailed processes and procedures, in accordance with regulatory requirements.
• Accountable for the routine administration and lifecycle management of the QMS including Deviations, CAPA, Change Control.
• Develop and maintain a systematic QRM program; partners with Resilience manufacturing sites and Clients to identify and mitigate risks in order to ensure the delivery of safe products to our patients.
• Support the periodic Global Quality Management Reviews to assess the health of the Quality Systems across Resilience.
• Leads Communities of Practice (CoPs) across the Resilience network for management of QMS and driving continuous improvement.
• Provides training on QMS processes, corresponding regulatory requirements, and best industry practices.
• Identifies and promotes technologies needed to advance the impact of the QMS, and partners with Digital teams to define the requirements for related electronic QMS.
• Act as a Global QMS representative/SME/approver.
• Supports inspection readiness and interacts with regulatory agencies during inspections, as Global SME on QMS processes and procedures.
• 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.

Minimum Job Qualifications

• Comprehensive knowledge of global GxP regulatory requirements.
• Experience with implementing and managing an effective QMS programs is required.
• Experience with implementation and lifecycle management of an electronic Quality Management System (eQMS) is required.
• Experience interfacing with regulatory authorities to present a QMS and corresponding business processes during inspections is required.
• Excellent oral and written communication skills with strong technical writing experience are required.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
• Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.
• Ability to travel (approx. 20%)

Preferred Job Qualifications

• Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, Regulatory Sciences or related field
• Substantial pharmaceutical industry experience, with significant experience in Quality Systems or Quality Assurance leadership roles; experience in biotechnology and cell & gene industry preferred.

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 s