Senior Specialist II, Technical Quality

Resilience•West Chester, OH

About The Position

The Technical Quality Senior Specialist II plays 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 combines technical expertise, quality assurance knowledge, and leadership capabilities to collaborate across departments and lead initiatives that enhance product quality and process efficiency. The Senior Specialist II provides quality oversight of validation, investigations, and technology transfer, and may work independently or lead specialized projects, providing strategic insight and technical advice. The role supports manufacturing quality and compliance with local and global regulatory standards, including GMP, FDA, EMA, and ICH guidelines. It collaborates with MSAT, Project Management, Engineering, and other departments to integrate new products and technologies into manufacturing. The position requires approximately 5–10% travel based on project demand and has an expected Monday–Friday, 8 a.m.–5 p.m. schedule, subject to change based on business needs. Work authorization or visa sponsorship is not available.

Requirements

Strong technical experience in qualification of equipment, utilities, and facilities; technology transfer and process validation; and/or quality oversight in these disciplines.
Thorough knowledge of industry best practices and regulatory guidance expectations regarding technology transfer and validation.
Strong leadership, relationship management, and organizational planning skills.
Experience supporting audits and regulatory inspections.
Experience using risk assessment tools such as FMEA, HACCP, LOPA, PHA, and simple Lean tools.
Expertise in quality management systems.
Excellent problem-solving skills and ability to work under pressure in a fast-paced environment.
Strong interpersonal skills, including 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.
Proficient computer skills and experience with Microsoft Office, including Word, Excel, PowerPoint, and Outlook.

Nice To Haves

Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or a related field.
At least 8 years of combined experience in quality assurance and/or validation in 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 aseptic fill/finish manufacturing experience.
Experience within a multi-product facility.
Experience with sterile manufacturing processes.
Previous experience leading or supporting regulatory inspections and audits.

Responsibilities

Provide quality oversight for complex investigations, validation protocols, and technology transfer documents, ensuring compliance with specifications, procedures, and regulatory requirements.
Review and approve complex validation documents, including validation plans, requirements 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 serve as a subject matter expert and/or host during internal, regulatory, and customer audits and inspections.
Review and approve initial investigation impact assessments to determine deviation classifications.
Provide quality oversight, review, and approval for deviations, CAPAs, change controls, and risk assessments.
With the Lead Investigator, lead major or critical investigations and resolution of product quality issues and non-conformances, ensuring timely and effective corrective actions.
Drive and support continuous improvement initiatives to enhance product quality and manufacturing efficiency.
Ensure manufacturing operations comply with local and global regulatory standards, including GMP, FDA, EMA, and ICH guidelines.
Collaborate with MSAT, Project Management, Engineering, and other departments to integrate new products and technologies into manufacturing processes.
Assist in reviewing and approving new product introductions, ensuring quality standards are met throughout the product lifecycle.
Lead risk assessments, such as sFMEA, and implement strategies to mitigate technical and quality risks associated with manufacturing processes.