QA Compliance Manager

Job Description

Supervise Teams Participation in Supplier Audits and Certification programs, including the following:

Auditing suppliers through surveys and on-site

Preparing audit reports

Audit Scheduling and Coordination

Supervise Teams Facilitation and participation in Internal Audits

Perform and facilitate internal audits as indicated in schedule

Mentor and train volunteer assessors

Facilitate and host on-site Customer and Regulatory audit/inspections

Prepare site audit responses by collaborating with site SMEs and department heads and oversee timely completion of commitments thereof

Ensure effective communication and dissemination of commitments

Track, trend, report, and provide follow-up, and drive closure of audit/inspection commitments

Facilitate approval of audit/inspection commitments

Author/compile on-demand, monthly, quarterly and annual summaries and metrics associated with compliance activities

Serve as compliance SME for internal SOPs and serve as Quality and Regulatory approver for site SOPs

Create training curriculum and manage program to assure site personnel are adequately credentialed to perform Internal assessments and Supplier audits/certifications programs

Work with site management to identify training courses to assure site personnel receive appropriate ongoing training in cGMPs and handling controlled substances

Provide support for Field Alert and Recall activities initiated by site or Customer as directed by Regulatory Affairs or Quality Assurance Managers

Provides direction and oversight during active processes and applies understanding of FDA regulations (21 CFR 11, 21 CFR 820), FDA Quality Systems and Continuous improvement.

Able to independently organize and perform own work tasks and assist coordinating activities to support production schedule thru other co-workers.

Correct weaknesses, ineffective procedures, policy exceptions and discrepancies and performs or approves appropriate corrective actions followed by effective rates with the aim of being able to offer optimum quality control and quality guarantees.

Requirements

Bachelor s Degree in Science (Chemistry, Microbiology or Biology preferred) preferred however relevant years of experience will be considered;

A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.

Experience working with customers Contract manufacturing experience preferred

Prior experience working with validation or technical services preferred.

Prior experience interpreting DEA regulations

Proven ability to multi-task and demonstrate diplomatic skills.

Must possess excellent English verbal and written communication skills.

Intermediate to proficient skills in Microsoft Office applications