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 & Role:
The Digital Quality Lead will have expertise in quality assurance and compliance of level 4 ERP digital systems providing proficiency in ERP systems and serialization, to champion operational efficiency and compliance. This role involves collaborating with a global, cross-functional team of SMEs to design workflows for optimal system efficiency. This is a site-based role in West Chester, OH.
Establish and enforce quality assurance processes and standards to ensure the delivery of robust and reliable SAP solutions.
Apply a comprehensive understanding of ERP systems to ensure quality-related components such as master data, inventory management, and product release are optimized. Identify potential issues and develop strategies to mitigate risks. Develop, review, and approve life cycle documentation, Change Controls, Validation Plans, URS, FRS, etc.
Collaborate with cross-functional teams to provide serialization support ensuring data integrity and traceability in compliance with regulatory requirements.
Ensure all system designs and processes adhere to industry regulations and internal standards. Generate regular reports and data analysis to monitor system performance, improve quality control processes, and ensure consistent compliance with standards and regulations.
Lead 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).
Represent site Digital Quality at various quality leadership boards, enabling the adoption of corporate dQ and Data Integrity standards.
Provide Digital Quality support for deviations, investigations and Corrective and Preventative Actions (CAPAs) associated with computerized and software systems, and present and defend digital Quality (dQ) and Data Integrity programs at client audits and regulatory inspections.
Drive the assessment and risk management and remediation strategy and execution plan for Data Integrity controls (including testing) of ERP and Serialization 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.
Oversee Digital System / Vendor audits at the site level.
Lead and conduct training on Electronic Records (21CFR11), computer system validation (CSV), Data Integrity, and relevant Quality SOPs at the site level.
Serves as a liaison between site functions (including Manufacturing, Tech Ops, Quality Control and Quality Assurance, Validation) and the central dQ and Data Integrity functions.
Maintain systems in a state of inspection readiness and advise SMEs on maintaining this state.
Provide quality oversight of SAP life-cycle implementation, data migration, and implementation and management of Serialization.
Coaches and mentors other subject matter experts and/or contract staff on digital system qualification and regulatory/compliance requirements.
Extensive experience in the pharmaceutical/biotechnology industry or a related field, with strong expertise in ERP systems and Serialization.
Senior Technical role within IT Compliance/Quality, focusing on IT/Automation Computerized and Software systems.
Excellent oral and written communication skills with strong technical writing experience.
Bachelor’s degree or higher in IT, Computer systems, Life Sciences, Engineering, or a related field
Communicate quality-related principles and applicable compliance requirements to the executive leadership team, members of the Steering Committee Board, and the greater organization. This includes authoring procedures, leading training, presenting to all levels of the organization, and monitoring implementation effectiveness.
Drive continuous improvement through strategic quality planning processes.
Excellent communication, presentation, risk-based decision-making, and negotiation skills.
Strong problem-solving, strategic thinking, and critical analysis skills; ability to execute an appropriate course of action that complies with quality and regulatory requirements while supporting business objectives.
Experienced in working on the full life cycle implementation, Design, Realization, Testing, User trainings, Pre and Post Go-Live for SAP and Serialization.
Knowledge of global GxP regulatory requirements and guidance, including GMP, GLP, GDocP, GDP, and GCP as needed.
Demonstrated ability to set goals, perform long-term quality project planning, and influence and effectively collaborate with stakeholders to prioritize and align business needs with Resilience strategic goals and budget.
Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.
Experience in developing and managing an effective Computerized and Software Systems Quality Assurance program and team.
Demonstrated experience in assuring data integrity controls in Computerized and Software Systems.
Familiarity with PaaS and SaaS models, and BI tools such as Tableau or similar tools.
Proven ability to set goals, perform long-term quality project planning, influence, and collaborate with stakeholders to align business needs with strategic goals.
Ability to travel domestically and internationally.
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 base pay hiring range for this position is $115,000.00 - $171,250.00 per year. 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.