Senior Manager, Quality Assurance
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 & Role
The Sr. Manager, Quality Assurance is accountable to organize and execute aspects of cGMP, specifically maintaining quality systems and compliance to support the Advanced Development and Manufacturing Facility in the Alachua, Florida franchise. The Sr. Manager, Quality Assurance will be responsible for shop floor duties, compliance activities, product record review and disposition, and quality management system deliverables.
- Responsible for hiring, training, supervising, and performance management of staff.
- Manage QA Shop Floor activities for GMP operations in the manufacturing and warehouse areas including but not limited to:
- Perform critical process observations, manufacturing batch record review, room clearances, GEMBA walkthrough program
- Ensure compliant operations, maintaining an inspection-ready state
- Serve as first-line for event notification, triage support, immediate action approvals, containment approvals, guidance for event handling
- Coordinate and execute QA support activities within Manufacturing Operations.
- Work collaboratively with internal stakeholders and as necessary external partners to ensure the manufacturing and testing operations comply with all US and International regulatory expectations.
- Serve as a subject matter expert in GMP and provide technical expertise for QA operations.
- Serve as client communication liaison and collaborate with client persons in the plant as required
- Build collaborative interfaces with all stakeholders to ensure quality systems such as deviation, investigations, CAPA, change controls and quality documents are in place and followed.
- Manage, review, and approve deviations, change controls, CAPAs, and/or Risk Assessments.
- Ensure Manufacturing Batch Record review is complete and on time.
- Lead and provide oversight of disposition activities for manufactured batches.
- Author and/or review and approve technical documents including but not limited to SOPs, and various quality reports.
- Review and approval of Method Qualifications, Laboratory Investigations, and Environmental Monitoring.
- Coach, mentor, and develop the QA Operations personnel, ensuring robust coverage of skills and capabilities for QA Oversight of operations.
- Additional responsibilities assigned, as needed.
Preferred Experience & Qualifications
- Demonstrated quality experience and the ability to collaborate with and effectively influence others.
- Demonstrated experience with supporting manufacturing and support groups, gowning, and following aseptic behaviors.
- Strong analytical, critical thinking, and problem-solving skills.
- Excellent oral and written communication and leadership skills.
- Good project management skills.
- Ability to analyze risk and make decisions.
- Comfortable in a fast-paced, collaborative environment, working with minimal direction and able to adjust workload based upon changing priorities.
- Familiarity with electronic quality systems/software applications.
- Familiarity with electronic laboratory and manufacturing execution systems (i.e., Veeva, Mastercontrol, LIMS, etc.).
- Experience in regulatory authority site inspections, client audits, and associated responses.
- Experience supporting biologics manufacturing.
- Ability to collaborate and manage conflict in a fast-paced environment, working across functions.
- Bachelor’s degree or higher in a Life Sciences discipline.
- Working knowledge of GLP/GCP and GxP Regulatory requirements.
- 7-10 years of relevant life sciences quality experience within quality and/or quality-related functions.
- 3 - 5 years of management experience within the pharmaceutical/biotechnology industry.
Physical Requirements: (rows or statements that are not required to perform the duties of the position)
This job requires the employee to perform the following physical activities:
- Use of fingers
- Repetitive motion
This job requires the employee to work in the following conditions:
- Temperature changes
- Activities occur inside and outside
This job requires exposure to the following:
- Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
- Narrow aisles or passageways.
This job requires the employee to perform the following type of physical work:
- Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
This job requires the following visual acuity requirements:
- preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
- determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).
This job requires routine or periodic use of respiratory protection:
N/AResilience 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 $135,000.00 - $180,000.00. 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.