Senior Specialist II, Quality Compliance & Client Liaison

Resilience; Kentucky; On-site; USD 100,000 - 144,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) with company match

Health, dental, and vision

Paid vacation

Paid holidays

Tuition reimbursement

Family building benefits

Life and disability insurance

Job summary

Resilience is seeking a Senior Specialist II – Quality Compliance & Client Liaison to lead site quality programs and act as the primary quality contact for pharmaceutical clients.

You will own QAAs, coordinate QA-related communications, lead self-inspections, monitor quality metrics, and advise leadership on risk and regulatory trends across FDA, EU, and ISO guidelines.

Qualifications

• Strong knowledge of cGMP in Pharma/Biotech and regulatory guidelines.
• Experience with aseptic and sterile product manufacturing processes, inspection, packaging, labeling, testing.
• Excellent investigational and QA problem-solving skills.
• Strong leadership, project management, and technical writing skills.
• Strong interpersonal, communication, and influencing skills.
• Experience in tracking and trending meaningful metrics.
• Ability to work independently and collaboratively on multidisciplinary and multifunctional teams.

Responsibilities

• Act as primary point of contact for client quality matters and maintain professional client relationships.
• Own and maintain site Quality Agreements (QAAs) and the client-facing revision/update process.
• Review and monitor compliance with QAAs and client requirements.
• Lead client quality review meetings and provide updates on quality metrics and trends.
• Coordinate timely responses to client quality inquiries and site visits.
• Prepare quality metrics, trend analyses, and performance reports for clients.
• Ensure timely communication of quality risks and mitigation plans.

Skills

cGMP knowledge

Quality assurance

Leadership

Project management

Technical writing

Communication & influencing

Metrics & data analysis

Independent & collaborative work

Education

Bachelor's degree in science/technical field

Advanced degree or MBA

ASQ certifications (CQA/CQE/CQM)

Tools

SAP

Empower

LIMS

Job description

Job Summary

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

Senior Specialist II – Quality Compliance & Client Liaison

The Senior Specialist II, Quality Compliance & Client Liaison is responsible for providing both tactical and strategic leadership for some compliance management processes at the site, while serving as the site's primary quality point of contact for its pharmaceutical clients.

Core Responsibilities

• Serve as the functional leader/process owner of some site Compliance processes, including but not limited to: Quality Client Management, Quality Agreements, and Self-Inspections (Site Internal Audits).
• Serve as the site's primary quality client liaison, managing client quality communications, quality agreements, and coordination to support client quality and regulatory compliance.

Client Quality Management

• Act as the primary point of contact for quality-related client matters; build and maintain strong, professional client relationships throughout the product lifecycle.
• Own and maintain site Quality Agreements (QAAs) and attachments, including the client-facing revision/update process.
• Review, communicate, and monitor compliance with Quality Agreements and client-specific quality requirements.
• Lead client quality review meetings, QA-to-QA meetings, and provide client-facing updates on quality performance metrics and trends.
• Coordinate timely, accurate responses to client quality inquiries, requests, and coordinate client visits related to quality topics.
• Prepare quality metrics, trend analyses, and performance reports for clients.
• Ensure transparent and timely communication of quality risks and mitigation plans with clients.

Self-Inspections Leadership

• Lead and manage the site self-inspection (internal audit) program, owning program design, scheduling, execution, reporting, and CAPA follow-up.
• Monitor program health and effectiveness through metrics (completion rates, finding trends, repeat findings, CAPA closure timeliness), reporting status to site and client leadership.
• Contribute to the training, education, guidance, and influencing of operational and support areas on quality and compliance policy and practices.
• Coach and empower site colleagues to successfully execute quality systems and compliance processes.

Quality Compliance Management

• Develop, implement, and maintain SOPs, quality oversight plans, tools, and other supporting documents for the applicable compliance process.
• Partner with team leads on identified quality issues and quality/compliance trends, and work within the team to address and mitigate identified risks.
• Escalate and inform leadership and clients in a timely manner on the evaluation and management of site‑specific escalations, as applicable.
• Provide reports on quality trends, observations, and suggestions to leadership and clients, as applicable.
• Maintain current knowledge of regulatory and industry trends (e.g., 21 CFR 210, 21 CFR 211, 21 CFR 600s, 21 CFR 820, ISO 13485, Annex 1, etc.) and actively communicate those to the site.

Minimum Qualifications

• Strong knowledge of cGMP in the Pharma/Biotech industry, including FDA, EU, and JP regulatory requirements as well as ICH/ISO guidelines.
• Knowledge of pharmaceutical and biotechnology processes: aseptic and sterile product manufacturing processes, inspection, packaging, labelling, testing, etc.
• Excellent investigational and QA problem‑solving skills.
• Technical quality expertise.
• Strong leadership, project management, and technical writing skills.
• Strong interpersonal, communication, and influencing skills.
• Experience in tracking and trending meaningful metrics for assigned activities.
• Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams.

Preferred Qualifications

• Bachelor's degree in a science/technical field such as pharmacy, biology, chemistry, or engineering.
• Advanced degree or MBA is desirable.
• Extensive experience in QA/Regulatory Compliance in the pharmaceutical industry.
• Prior experience leading/managing regulatory inspections.
• Prior experience managing Quality Systems and compliance processes.
• ASQ certifications (e.g., CQA, CQE, CQM).
• Active member of pharmaceutical trade associations such as ISPE, PDA, etc.
• Prior experience in Quality Master Data (e.g., SAP, Empower, or LIMS systems configuration).

Work Schedule

Monday - Friday. The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, 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.

Equal Employment Opportunity

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.

Benefits & Compensation

• Our target base pay hiring range for this position is $100,000.00 - $143,750.00 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.
• annual cash bonus program
• a 401(k) plan with a generous company match
• 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
• support for caregiving needs

About the Company

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.