Role Summary

The Quality & Compliance Specialist II/III is responsible for establishing and maintaining quality agreements with suppliers and laboratories, maintaining supplier qualification through audits and questionnaires, evaluating change notifications from suppliers, and reporting on the supplier/material qualification status. They may also be responsible for conducting internal audits, participating in third-party audits, participating in and/or leading efforts towards site-preparedness/readiness for regulatory inspections. Additionally in this role, they will create schedules, select/manage audit team members, and manage work of self and team members.

PRIMARY ROLE RESPONSIBILITIES

• Establish and maintain quality agreements with suppliers and contract test laboratories.
• Maintain supplier qualification through audits and questionnaires, including managing, scheduling, conducting audits of suppliers and contract test laboratories.
• Lead and conduct internal quality audits in manufacturing, QC, facilities, warehouse, and utility areas according to established procedures, cGMP and company standards.
• Evaluate audit findings and ensure the implementation of appropriate corrective actions.
• Train auditors according to established procedures, cGMP and company standards.
• Review batch records, in-process documents, analytical data, and other documentation to ensure compliance with corresponding procedures, cGMP and company standards.
• Assist as needed in generation, review, and approval of protocols, reports, and other documents for regulatory submissions.
• Participate in and/or host third-party audits.
• Participate in and/or lead efforts towards site-preparedness/readiness for regulatory inspections (including PAI/PLI).
• Prepare/present reports to stakeholders (e.g. Executives, Quality Review Board, Management, etc.).

SKILLS

• Sound knowledge of cGMPs
• Excellent written and verbal communication skills, including the ability to tailor communications to all levels in the organization and prepare appropriate updates to senior management / executives.
• Strong interpersonal and leadership skills, along with adaptability, integrity, self-awareness, collaboration, and advocating for continuous improvement.
• Must be able to prioritize a variety of competing tasks.

QUALIFICATIONS

Education/Experience:

• B.S./B.A. in science-related field plus 6-8 years of related work experience in an FDA- regulated GMP environment, or
• M.S. in science-related field plus 3-6 years of related work experience in an FDA-regulated GMP environment.
• Experience with cGMP environments and quality systems is required.
• CQA or other auditor qualification / certification is preferred.
• Experience with hosting audits and interacting with health authority agencies is a plus.