Quality Systems Lead

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

This Quality Systems Lead is responsible for overseeing the GMP Quality System Management program, including deviations, training, change controls, CAPAs, and document management. Timely escalate and inform site leadership regarding the evaluation and management of site-specific issues, as appropriate.

Job Responsibilities

• Provide reports on quality trends, observations, and suggestions to leadership, as applicable.

• Lead/drive improvements to quality systems/compliance processes through cross functional project teams.

• Work in partnership with the Global Process Owner (where applicable) to ensure compliance with global policies.

• Leads and manage the site self-inspection program.

• Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.

• Build strong relationships and collaborate closely with CMC/Operations/Development teams and other relevant groups to ensure the quality documentation system complies with all US and International regulatory expectations.

• Manage the site electronic quality management processes in alignment with network standards and act as site Business Process Owner (BPO).

• Lead Quality System Review Boards, as applicable. Lead Quality Metrics Review Board for the site.

• Manages the Corporate Quality Metrics Review Board for the site.

• Assist with the document disposition activities and act as site Business Process Owner (BPO), as needed.

• Author and review technical documents including but not limited to SOPs, various quality reports.

• Manage and execute quality system processes including procedures, validation, deviation management, change control, CAPAs, etc.

• Accountable for training activities and act as site Business Process Owner (BPO).

• Coordinate and Lead site self-inspections and internal audits.

• Coordinate and Lead client audits at the site.

• Support additional Quality initiatives, as needed.

Minimum Qualifications

• Demonstrated quality experience and the ability to collaborate with and effectively influence others.

• Expertise with quality systems/software applications.

• Working knowledge of GLP/GCP and GxP Regulatory requirements.

Preferred Qualifications

• B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).

• 5+ years relevant life sciences quality experience within quality and/or quality related functions.

• Minimum of 3 years of QA systems experience.

• Hands-on experience with the management of Quality records (e.g. deviations, change controls, CAPAs, etc).

• Experience with Computer Systems Validation.

• Experience in preparation and participation in client audits or regulatory authority plant/site inspections.

• Experience with mentoring or coaching other quality professionals.

• Performs with integrity.

• Excellent oral and written communication skills.

• Comfortable in a fast-paced, collaborative company environment and able to adjust workload based upon changing priorities.

• Reputation for superior customer service.

• Driven to reduce complexity and create simple and organized data systems.

• Proficiency in creating high quality procedures that are easy to read and understood.

• Desire and interest to leverage new technology and innovative information management tools.

• Build and maintain effective internal Resilience business relationships within operational and support units.

• Promote and encourage continuous improvement in efficiency, quality, production, and safety using team driven processes and key performance indicators and recognizing and rewarding high performance.

• Empower site colleagues to successfully execute quality systems and compliance processes.

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.