Brief Job Description

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. The core responsibilities of the role are as follows:

• 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.

Job Responsibilities

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.