Relocation Assistance OfferedGeneral 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. For more information, visit www.resilience.com.
Position Summary & Role
Provide Quality oversight of Digital Systems (Computerized and Software Systems including Laboratory Instrumentation) implementation across all phases of the System Development Lifecycle and associated artifacts at the Resilience’s East Norriton, PA Facility.
Review and approve life cycle documentation, Change Controls, Validation Plans, URS, FRS, etc.
Responsible for providing Digital Quality (dQ) support for Deviations and CAPAs associated with Computerized and Software Systems.
Responsible for presenting and defending dQ and Data Integrity (DI) programs and associated verification artifacts at client audits and regulatory inspections.
Leads dQ and DI initiatives at the site.
Leads and works with site cross-functional team to assist in establishing alignment, harmonization, and standardization with corporate-wide Digital Systems Governance Programs (such as SDLC, Data Integrity, Risk Management, Periodic Reviews, and others)
Act as a Data Integrity steward, responsible to:
- Ensure site adherence to the defined Resilience Data Integrity Program.
- Drive the assessment and risk management and remediation strategy and execution plan for Data Integrity controls (including testing) of digital systems procured by and/or designed/developed in-house at Resilience; collaborate with site stakeholders and central DI program lead to institutionalizing on-site.
- Define appropriate DI controls as part of purchasing and implementing equipment/systems and processes.
- Ensure site Quality and compliance of GxP activities with respect to internal and/or customer procedures as well as FDA, ICH, EU, and country-specific regulations
- Serves as a liaison between site functions (including Tech Ops, business QC/QA, and Validation) and the central dQ and Data Integrity functions.
- Lead/assist/oversee Digital System / Vendor audits per established risk-based strategy at the site level.
- Lead/conduct/oversee training of Resilience personnel on Electronic Records (21CFR11), CSV, Data Integrity, and relevant Quality SOPs at the site level.
- Represent site Digital Quality at site quality leadership, site Quality Review Board and the central dQ/DI and Governance boards to enable the adoption of corporate dQ and Data Integrity standards.
- Assists in the development systems strategy that pilots and implements efficient, cutting-edge technology on new platforms, including intelligent robotic automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies at the site and central functions.
- Always maintain systems in a state of inspection readiness.
- Assess and advise SMEs on maintaining systems in a state of inspection readiness.
- Establish and report to site leadership and corporate leadership on site-based dQ/DI KPIs.
- Assist in internal audits, customer audits, and regulatory inspections.
- Recruits talent (contract and/or full-time) as appropriate and builds a high-performance team; mentors and coaches' personnel.
Preferred Experience, Education & Qualifications
- Comprehensive knowledge of global GxP regulatory requirements and guidance, including GMP, GLP, GDocP, GDP, and GCP as needed.
- Hands-on experience in developing and managing effective Computerized Software
- Systems Quality Assurance program in support of COTS and customized GxP computerized systems to meet Digital needs.
- Hands-on experience in building and managing teams focused on providing quality oversightof computerized systems validation programs.
- Demonstrated experience in assuring data integrity controls are designed and adhered to in computerized and Software Systems.
- Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
- Demonstrated ability to set goals, perform long-term quality project planning, influence and effectively collaborate with stakeholders to prioritize and align business needs with Resilience strategic goals and budget
- Demonstrated ability to execute responsibilities in a fast-paced environment successfully, collaborating across multiple sites and stakeholders
- Managed a high-performance team.
Bachelor’s degree or higher in IT, Computer systems, Life Sciences, Engineering, or a related field
Minimum of 15 years of pharmaceutical/biotechnology industry experience, with a minimum of 10 years in an IT Compliance/Quality leadership role (with a primary focus on IT/Automation Computerized and Software systems)
Excellent oral and written communication skills with strong technical writing experience
This job requires the employee to perform the following physical activities:
·Use of fingers
This job requires the employee to work in the following conditions:
·Activities occur inside and outside
This job requires exposure to the following:
·Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
·Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
·Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
·Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
·Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
·Narrow aisles or passageways.
This job requires the employee to perform the following type of physical work:
·Sedentary work.Exerting up to 10 pounds of force occasionally and/or negligible force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
·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.
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 $131,000.00 - $166,250.00. 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.