Sr. Manager, Quality Compliance Audits

Role Summary

Sr. Manager, Quality Compliance Audits responsible for coordinating and preparing GxP and ISO internal and external audits in accordance with regulatory standards, assessing compliance risks, and leading audit activities across functional areas and vendors.

Responsibilities

• Complete auditor qualification using On-the-Job-Training to demonstrate and document auditing competency.
• Contribute to vendor selection by evaluating external providers for quality, business, and technology fit against defined requirements.
• Manage the external audit program for vendors and contract facilities affecting cGMP/ISO/MDSAP processes, including drug product, delivery system, and packaging.
• Maintain the GLP audit program by approving or reapproving CROs and GLP vendors for compliance.
• Maintain the GCP/PV external audit program; audit clinical investigators, trial sites, CROs, and related entities providing GCP/PV services.
• Maintain the approved vendors list of suitable vendors, contract organizations, and service providers based on audits.
• Manage quality agreements and provide current agreements status for the Annual Product Review submission to the Agency.
• Manage supplier change notifications and supplier relationships regarding non-conforming materials, deviations, and CAPA; develop vendor performance metrics.
• Manage the internal audit program tracking compliance to internal quality systems and procedures across all cGMP/ISO/MDSAP operations.
• Oversee QC of regulatory submissions, reviewing documents for regulatory submission support and clinical quality oversight.
• Maintain regulations, standards, and externally derived guidance documents.

Duties may include additional assignments as necessary. The role requires professional, detail-oriented, solutions-focused collaboration within the Quality organization.

Qualifications

• BA/BS in a scientific discipline with 10‚Äì12 years or MS/MBA with 6‚Äì8 years of related experience, or equivalent combination of training and experience.
• Knowledge of CFR 210 and 211.
• 10‚Äì12 years of experience, preferably in pharmaceutical or regulated environments.
• Knowledge of GxP Compliance and ISO standards.
• Previous management, supervisory, or project coordination experience.
• Proficiency in MS Word, Excel, and PowerPoint.
• Travel 30‚Äì50 percent.
• Excellent written and verbal communication skills; strong interpersonal skills and ability to influence others in sensitive situations.

Skills

• Auditing (internal/external) and lead auditor capabilities
• Quality systems and regulatory compliance
• Vendor management and CAPA
• Documentation review and regulatory submission support
• Cross-functional collaboration and communication

Education

• As listed in Qualifications (BA/BS or MS/MBA in a scientific field).

Additional Requirements

• Travel up to 50% as part of the role.