Senior Quality Compliance & Client Liaison Lead

Resilience; Olde West Chester (OH); On-site; USD 100,000 - 144,000; Full time

Benefits offered by this job

Base pay $100k-$143,750 per year

Annual cash bonus

401(k) with company match

Healthcare (medical, dental and vision

Family building benefits

Life and disability insurance

Paid vacation

Paid holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience is seeking a Senior Specialist II to lead quality compliance and act as the primary client liaison for pharmaceutical clients. This role drives quality governance, client communications, and regulatory alignment across site processes.

The candidate will own QAAs, lead audits, manage CAPAs, and deliver metrics and trend analyses to clients and leadership. Strong cGMP knowledge and cross-functional collaboration are essential in this role.

Qualifications

• Strong knowledge of cGMP in the Pharma/Biotech industry including FDA, EU, and JP regulatory requirements and ICH/ISO guidelines.
• Knowledge of pharmaceutical and biotechnology processes: aseptic and sterile product manufacturing, inspection, packaging, labeling, testing.
• 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 teams.

Responsibilities

• Serve as the functional leader/process owner of site Compliance processes including 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.
• 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.
• Lead and manage the site self-inspection program with design, scheduling, execution, reporting, and CAPA follow-up.
• Develop, implement, and maintain SOPs, quality oversight plans, tools, and other supporting documents for the applicable compliance process.
• Provide reports on quality trends, observations, and suggestions to leadership and clients.

Skills

Quality management

Regulatory compliance

Leadership

Project management

Technical writing

Communication

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in science/technical field such as pharmacy, biology, chemistry, or engineering

Advanced degree or MBA

Tools

ASQ certifications

SAP

EMPOWER

LIMS

Job description

Resilience is seeking a Senior Specialist II to lead quality compliance and act as the primary client liaison for pharmaceutical clients. This role drives quality governance, client communications, and regulatory alignment across site processes.

The candidate will own QAAs, lead audits, manage CAPAs, and deliver metrics and trend analyses to clients and leadership. Strong cGMP knowledge and cross-functional collaboration are essential in this role.