Sr. Manager, Quality Compliance Audits

Role Summary

Sr. Manager, Quality Compliance Audits oversees coordination and preparation of GxP and ISO internal and external audits in line with regulatory standards, assessing compliance risks and leading audit activities and planning for other auditors. This role may be based in Danbury, CT or Burlington, MA.

Responsibilities

• Complete auditor qualification using on-the-job trainings and document demonstrated competency.
• Contribute to vendor selection by evaluating external providers for quality, business, and technology fit.
• Manage external audit programs for vendors and contract facilities with direct or indirect impact on cGMP/ISO/MDSAP processes.
• Maintain the GLP audit program by approving or reapproving CROs and GLP vendors as required.
• Maintain the GCP/PV external audit program; audit clinical investigators, trial sites, CROs, vendors, and related entities providing GCP/PV services.
• Maintain the approved vendors list for vendors, contract organizations, and service providers.
• Manage quality agreements and provide a current listing of all agreements as part of the Annual Product Review.
• Manage supplier change notifications that do not require MannKind's approval to proceed.
• Manage 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 and areas.
• Oversee QC of regulatory submissions and document reviews in support of regulatory submissions or clinical quality oversight.
• Maintain regulations, standards, and guidance documents of external origin.

Qualifications

• BA/BS in a scientific discipline with 10‚Äì12 years of related experience or MS/MBA with 6‚Äì8 years; 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; ability to influence others in sensitive situations.

Skills

• Auditing and lead auditor capabilities
• Vendor management and supplier relationship management
• Quality systems and regulatory submissions
• Cross-functional collaboration

Education

• As listed in Qualifications

Additional Requirements

• Travel 30‚Äì50 percent