Senior Specialist II, Technical Quality

A career at Resilience is more than just a job its an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company thats changing the way medicine is made . Were 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.

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Position Summary

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 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. The Senior Specialist II has advanced technical expertise to be able to provide quality oversight of validation investigations and technology transfer. They may work independently or lead specialized projects in their area of expertise providing high-level strategic insight and technical advice.

Responsibilities

• Provide quality oversight for complex and/or higher-level investigations validation protocols and technology transfer documents ensuring adherence to established specifications procedures and regulatory requirements.
• Provide quality oversight review and approval of complex and higher-level 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 and/or host 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 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. sFMEA) 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 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.
• 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

• Bachelors degree or higher in Pharmaceutical Sciences Chemistry Engineering Life Sciences or related field.
• Minimum of 8 years of total 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 aseptic fill/finish manufacturing experience.
• Experience within a multi-product facility.
• Experience with sterile manufacturing processes.
• Previous experience in leading or supporting regulatory inspections and audits.

Work Schedule: M-F 8am - 5pm

The work schedule listed reflects the employees expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time with or without notice based on business needs operational requirements or other considerations. Nothing in this description creates a guarantee of specific hours days or shift assignments.

Sponsorship or support for work authorization including visas is not available for this position.

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 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 paid vacation paid holidays other paid leaves of absence tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $100000.00 - $143750.00 per year. Actual base pay is dependent upon a number of factors including but not limited to the candidates geographical location relevant experience qualifications skills and knowledge. Excited about Resilience We encourage you to apply and start a conversation with one of our recruiters.

Required Experience:

Senior IC