Spectrum Staffing Services/HRStaffers
SUMMARY
Our client, a leading pharmaceutical ingredient distributor and manufacturer, is seeking a QA Manager to join their team. This global organization is offering a competitive benefits package and dynamic team driven environment! In alignment with organizational goals, we are looking for a Quality Assurance Manager who will support in the development of the Quality department & in the day-to-day activities associated with Quality, Operations and Regulatory departments.
RESPONSIBILITIES
- Act as the Subject matter expert on all FDA regulations and requirements as well as the advisor to the senior management team; in addition to acting as the liaison for all regulatory agencies
- Spearhead the company’s Quality Assurance functions while building a team of likeminded individuals
- Demonstrate a strong partnership with cross-functional teams, mainly Operations and QC
- Act as the “go to” for audits and inspections (including readiness), as appropriate.
- Maintain SCMs compliance with cGMPs
- Manage Out of Specification investigations reports
- Review product and process deviations
- Review New product set up
- Participate in the evaluation, selection service providers
- Provide GMP, ISO, GDP training to the team
- Manage ISO 9001 certification for SCM
- Manage Quality Documentation process
- Negotiate and maintain vendor Quality Agreements
- Provides guidance to peers regarding Quality and regulatory issues. Prepares and reviews annual reports and supplements for marketed products.
- Accountable for Raw Material Change control program
- Support SCMs Vendor Management initiative
- Supervises the identification and compilation of required documentation for submissions. Function as the quality lead for any assigned projects; providing support to the Operation, Quality Assurance units as needed.
- Write/review and update Standard Operating Procedures
- Independently prepare and submit meeting requests and meeting packages, leading all company quality and regulatory meetings.
- Provides expert opinion, advice, and recommendations to the organization regarding quality processes.
- Problem-solve quality issues to preserve original timeline for various projects; track progress while being accountable for quality system deliverables.
- Accountable for maintaining the organizations adherence to all relevant Quality requirements. Perform other duties as required, interfacing with other departments, customers and external vendors as needed.
- Help drive a LEAN culture by mentoring and creating training opportunities. Internal quality system audit and remediation skills required.
- Collect data, analyze outputs, and determine corrective courses of action to promote safety, quality, and efficiency
- Identify ways to eliminate waste in production processes.
- Analyze and identify opportunities to reduce process variation, improve process capabilities and optimize process performance.
- Work with management to identify new process improvement opportunities in the areas of quality, cost, performance, and preventive and predictive maintenance.
- In-depth experience implementing Lean, 5S, Value Stream Map and Kaizen
QUALIFICATIONS
- Candidate must have a bachelors degree from a four-year college, strong preference for a background in Chemistry
- Minimum of 5 years experience managing teams, building, and managing a dynamic team
- Minimum of 5 years experience leading and managing Customer & Supplier Audits
- Minimum of 5 years experience leading and managing FDA/DEA/Regulatory inspection experience
- Minimum of 5 years experience in a GMP, GDP environment
- Experienced in the investigation of OOS, Complaints, CAPAs, SCARs, Deviations
- Experience in Change Control, Process Improvement, Lean, Project Management
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