Manager, Technical Quality (Sterile Operations) Position Available In Chester, Pennsylvania

Job Description:

A career at Resilience is more than just a job – it’s anopportunity to change the future. Resilience is atechnology-focused biomanufacturing company that’s changing the waymedicine is made. We’re building a sustainable network ofhigh-tech, end-to-end manufacturing solutions to better withstanddisruptive events, serve scientific discovery, and reach those inneed. For more information, please visit www.resilience.com

Position Summary:

The Manager, Technical Quality (SterileOperations) will play a pivotal role in ensuring the technical andoperational quality of products, driving continuous improvement inmanufacturing processes, and ensuring compliance with regulatorystandards. This position requires a blend of strong technicalexpertise, quality assurance knowledge, and leadership capabilitiesto effectively collaborate across departments and lead initiativesthat enhance product quality and process efficiency. This positionrequires quality oversight of validation, investigations, andtechnology transfer. The Manager, Technical Quality (SterileOperations) will lead a team of Technical Quality Specialists andcollaborate across functions to drive operational excellence, riskmanagement, and innovation.

Position Responsibilities:

Providequality oversight for investigations, validation, and technologytransfer, ensuring adherence to established specifications,procedures, and regulatory requirements. Provide quality oversight,review, and approval of internal validation documents includingvalidation plans, requirement documents (URS, FS, SRA, SLIA, andACA), protocols, data analysis, discrepancies, and final reports.

Represent the Technical Quality group in project teams, audits, andinspections, as required. Provide hands-on support and act as anSME during internal, regulatory, and customer audits andinspections. Perform reviews and approvals of investigation initialimpact assessments to determine the classification of deviations.

Provide quality oversight, review, and approval for deviations,CAPAs, Change Controls, and various risk assessments. Inconjunction with the Lead Investigator, lead major/criticalinvestigations and resolution of product quality issues andnon-conformances, ensuring timely and effective corrective actions.

Drive and support the development and implementation of continuousimprovement initiatives to enhance product quality andmanufacturing efficiency. Ensure manufacturing operations complywith local and global regulatory standards, including but notlimited to GMP, FDA, EMA, and ICH guidelines. Collaborate withMSAT, Project Management, Engineering, and other departments toensure seamless integration of new products and technologies intothe manufacturing process. Assist in the review and approval of newproduct introductions, ensuring quality standards are metthroughout the product lifecycle. Lead risk assessments (e.g.sFMEA) and implement strategies for mitigating technical andquality risks associated with manufacturing processes. Lead,mentor, and develop a team of Technical Quality Specialists toensure optimal performance and professional growth. Overseeday-to-day operations, providing guidance and support onquality-related technical issues, process troubleshooting, andproblem resolution. Foster a culture of collaboration,accountability, and continuous improvement within the team andcross-functionally. Assist in the onboarding and training of newteam members and provide ongoing training to ensure adherence toquality standards and practices.

Minimum Qualifications:

Strongtechnical experience in the qualification of equipment, utilities,facilities, technology transfer and process validation, and/orQuality oversight in these disciplines. Thorough knowledge ofcurrent industry best practices and regulatory guidanceexpectations regarding technology transfer and validation. Strongleadership, relationship management, and organizational planning.

Experience supporting audits and regulatory inspections. Experienceusing risk assessment tools (e.g. Failure Modes and EffectsAnalysis (FMEA), Hazard Analysis and Critical Control Points(HACCP), Layers of Protection Analysis (LOPA), Preliminary HazardAnalysis (PHA), simple Lean tools, etc.). Expertise in qualitymanagement systems. Excellent problem-solving skills and theability to work under pressure in a fast-paced environment. Stronginterpersonal skills with the ability to lead cross-functionalteams and influence without direct authority. Excellent written andverbal communication skills, including technical writing fordocuments and reports. Ability and willingness to learn and adaptskills for various areas. Ability to travel approximately 5-10%based on project demand. Must have proficient computer skills andbe experienced in Microsoft Office, including Word, Excel,PowerPoint, and Outlook.

Preferred Qualifications:

Bachelor’sdegree or higher in Pharmaceutical Sciences, Chemistry,Engineering, Life Sciences, or related field. Minimum of 8 years oftotal combined experience in quality assurance and/or validationwithin a GMP regulated pharmaceutical and/or biotechnologymanufacturing environment. Experience in managing and leadingteams, with proven leadership skills. Direct experience with GMPregulatory requirements relevant to pharmaceutical manufacturing.

Proven track record in technical troubleshooting and root causeanalysis. Prior cGMP aseptic fill/finish manufacturing experience.

Experience within a multi-product facility. Experience with sterilemanufacturing processes. Previous experience in leading orsupporting regulatory inspections and audits. Resilience is anEqual Employment Opportunity Employer. Qualified applicants willreceive 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, geneticinformation, or characteristic, or other non-job-relatedcharacteristics or other prohibited grounds specified in applicablefederal, state, and local laws. Requests for reasonableaccommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards programincluding equity, an annual cash bonus program, a 401(k) plan witha generous company match and our benefits package which isthoughtfully designed to support our employees with greathealthcare (including medical, dental and vision), family buildingbenefits, life and disability insurance, flexible time off, paidholidays, other paid leaves of absence, tuition reimbursement andsupport for caregiving needs. Our target base pay hiring range forthis position is $95,000.00 – $143,750.00 per year. Actual base payis dependent upon a number of factors, including but not limitedto, the candidate’s geographical location, relevant experience,qualifications, skills and knowledge. Excited about Resilience andthe biomanufacturing revolution? We encourage you to apply andstart a conversation with one of our recruiters. As a requirementof this role, employees must have the ability to demonstrate andmaintain gown qualification standards. Please review the videobelow, which outlines the most extensive process to gown withinspecific areas of Sterile Operations at Resilience, WestChester.