Technical Quality 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
General Company Description
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. 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.
RESILIENCE (National Resilience, Inc.) is an equal-opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law. EEO Minorities/Women/Disabled/Veterans
For more information, visit www.resilience.com.
Position Summary & Responsibilities
The Technical Quality Lead will provide expertise in the quality engineering and validation team. This is an exciting opportunity to be the subject matter expert (SME) on the qualification program at the East Norriton cell therapy manufacturing facility reporting to the Director, Quality.
- Provide quality oversight of qualification for equipment, utilities, and instruments
- Provide quality input to new facility design changes as new customer needs are evaluated
- Implement global quality systems, procedures, and master plans at the site to support validated facility and equipment status throughout their lifecycle
- Decision-maker for validation/qualification strategies and escalation of issues to the Head of Quality Operations
- Provide Technical Quality support for internal and external teams and projects
- Participation in communities of practice related to qualification and validation, as needed
- Provide site oversight of method and process validation in alignment with global quality functions
- Partner with Digital Quality in providing Quality oversight for site-specific equipment and standalone laboratory instruments that have embedded software.
- Partner with functions, including F&E, Digital, QC, MSAT, etc. to implement quality system metrics for validation and change control systems in order to visualize status and continuously improve
- Provide technical presentations to senior management and external stakeholders, as needed
- Extensive experience in the pharmaceutical or biotechnology industry
- Demonstrated experience within a quality oversight function
- Comprehensive knowledge of global GMP regulatory requirements for qualification, validation hardware and software
- Ability to travel in the US and internationally, as needed, for critical FAT oversight
- Bachelor’s degree or higher in Life Sciences, Chemistry, Biology, Engineering or a related field
- Hands-on experience with oversight of GMP operations at a cell therapy, biologics, or gene therapy facility.
- Previous managerial experience, with proficiency in hiring talent and managing performance
- Proven record of building high-performing teams and developing talent
- Experience with the presentation of validation strategies and execution to auditors and inspectors
- Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders
- Ability to collaborate and manage conflict in a fast-paced environment, working across functions
- Excellent interpersonal, verbal, and written communication skills
- Experience in the application of lean methodologies and operational excellence to continuously improve
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 annualized base pay hiring range for this position is $95,000.00 - $132,500.00. 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.