QA Compliance Manager
Brooksville, FL US
QA Compliance Manager Role
- Title: Quality Assurance Compliance Manager
- Location: Greater Tampa Area, FL
- Industry: Pharmaceutical
- Salary: Based on Experience
- Employment Type: Direct Hire
Overview: The QA Compliance Manager will be responsible for auditing, mentoring, and facilitating internal/external audits. Will be the Subject Matter Expert (SME) for supplier audits and certification programs; and enforcing procedures to ensure a state of compliance utilizing FDA guides and current industry standards best practices to meet the requirements of internal policies, U.S., and International regulatory agencies.
The QA Compliance Manager will be responsible for Regulatory and Quality Systems Internal Audits. Support the organization to conform and comply with regulations, internal policies, directives, and procedures in order to achieve and exceed the quality objectives expected by the organization.
- 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.
- 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.
- 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.
- Work with site management to identify training courses to assure site personnel receive appropriate ongoing training in cGMPs and handling controlled substances.
- Provides 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.
- 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.
- Prior experience working with aseptic manufacturing 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.
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.