Senior Specialist, Technical Quality

Location: West Chester
Posted on: June 23, 2025

Job Description:

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: The Senior Specialist, Technical Quality (IDAP) will play a pivotal role in ensuring the technical and operational quality of products, driving continuous improvement in manufacturing processes, and ensuring compliance with regulatory standards. This position is responsible for QA activities that directly support the inspection, assembly, and packaging of pharmaceuticals and combination products with a medical device constituent part. This position requires a blend of strong technical expertise, quality assurance knowledge, and leadership capabilities to effectively collaborate across departments and lead initiatives that enhance product quality and process efficiency. This position provides quality oversight of validation, investigations, and technology/design transfer. Position Responsibilities: Provide quality oversight for investigations, validation, and technology transfer, ensuring adherence to established specifications, procedures, and regulatory requirements. Provide quality oversight, review, and approval of internal validation documents including validation plans, requirement documents (URS, FS, SRA, SLIA, and ACA), protocols, data analysis, discrepancies, and final reports. Represent the Technical Quality group in project teams, audits, and inspections, as required. Provide hands-on support and act as an SME during internal, regulatory, and customer audits and inspections. Perform reviews and approvals of investigation initial impact assessments to determine the classification of deviations. Provide quality oversight, review, and approval for deviations, CAPAs, Change Controls, and various risk assessments. In conjunction with the Lead Investigator, lead major/critical investigations and resolution of product quality issues and non-conformances, ensuring timely and effective corrective actions. Drive and support the development and implementation of continuous improvement initiatives to enhance product quality and manufacturing efficiency. Ensure manufacturing operations comply with local and global regulatory standards, including but not limited to GMP, FDA, EMA, ISO, and ICH guidelines. Collaborate with MSAT, Project Management, Engineering, and other departments to ensure seamless integration of new products and technologies into the manufacturing process. Assist in the review and approval of new product introductions, ensuring quality standards are met throughout the product lifecycle. Lead risk assessments (e.g. pFMEA) and implement strategies for mitigating technical and quality risks associated with manufacturing processes. Minimum Qualifications: Strong technical experience in the qualification of equipment, utilities, facilities, technology transfer, statistical analysis, investigation techniques, development, and risk management methodology and process validation, and/or Quality oversight in these disciplines. Thorough knowledge of current industry best practices and regulatory guidance expectations regarding technology transfer and validation. Demonstrated experience in a regulated environment (21 CFR 210, 211, 4, 820, ISO 13485, ISO 14971, EMA, PDA, ICH, etc.) Knowledge of Design Controls and experience with change management Strong leadership, relationship management, and organizational planning. Experience supporting audits and regulatory inspections. Experience using risk assessment tools (e.g. Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Layers of Protection Analysis (LOPA), Preliminary Hazard Analysis (PHA), simple Lean tools, etc.). Expertise in quality management systems. Excellent problem-solving skills and the ability to work under pressure in a fast-paced environment. Strong interpersonal skills with the ability to lead cross-functional teams and influence without direct authority. Excellent written and verbal communication skills, including technical writing for documents and reports. Ability and willingness to learn and adapt skills for various areas. Ability to travel approximately 5-10% based on project demand. Must have proficient computer skills and be experienced in Microsoft Office, including Word, Excel, PowerPoint, and Outlook. Preferred Qualifications: Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field. Combined experience in quality assurance and/or validation within a GMP regulated pharmaceutical and/or biotechnology manufacturing environment. Direct experience with GMP regulatory requirements relevant to pharmaceutical manufacturing. Proven track record in technical troubleshooting and root cause analysis. Prior cGMP inspection, medical device assembly, and/or packaging manufacturing experience. Experience within a multi-product facility. Experience with sterile manufacturing processes. Working knowledge of cGXP requirements for the manufacturing and inspection of pharmaceutical products and medical devices a strong familiarity with production operations. The items described here are representative of those that must be met successfully to perform the essential functions of this job. 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 $70,000.00 - $115,000.00 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.

Keywords: , Indianapolis , Senior Specialist, Technical Quality, Science, Research & Development , West Chester, Indiana