Manager Quality Assurance
WuXi AppTec
Marietta, Georgia
manager
quality assurance
assurance
regulatory
compliance
quality assurance
assurance
quality system
management
procedures
regulatory requirements
operations
personnel
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November 29, 2022
WuXi AppTec
Marietta, Georgia
WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Quality department for a Quality Assurance Manager. This position is responsible for organizing, planning & managing the personnel, systems & resources necessary to support the Quality Assurance program at WuXi AppTec. Works with site management teams to assure quality system & regulatory compliance & consistency with WuXi AppTec policies & procedures.
- Assure Corporate Quality and Compliance Policies and Procedures are implemented and administered at the site level
- Represent the company during regulatory inspections, ISO and client audits; coordinate the preparation of audit and regulatory inspection responses and follow-through of corrective action commitments
- Organize, plan and develop personnel, department resources, and departmental policies and procedures to assure compliance to applicable ISO and regulatory requirements for Quality System Management
- Schedule resources to manage compliance systems and assure timely completion of audits of quality records and reports; inspections of facilities and equipment; investigations; audits of methods, practices, and controls; supplier assessment for applicable regulatory, ISO, and internal procedural compliance; document control processes; CAPA system processes and related trending and reporting
- Responsible for the final approval of CAPA Investigations and subsystems; the approvals for Change Control
- Review and approve Quality Assurance reports of internal audits and investigations to assure correct and consistent interpretations of regulatory, ISO, and company requirements
- Assure quality records and reports are prepared, communicated, and retained in accordance with applicable company and regulatory requirements
- Manage programs for measuring compliance and quality through pertinent metrics on key performance indicators and provide periodic reports at Operational and Management Review meetings as scheduled
- Communicate identified compliance and quality risks to Quality Director and recommend solutions for improvement; perform follow-through on implementation of appropriate changes to systems and/or processes
- Assure staff receives appropriate quality system and regulatory training and guidance to facilitate the implementation of quality system and regulatory requirements.
- Conduct employee performance appraisals in a timely and objective manner.
- Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems.
- Contributes to the overall operations and to the achievement of departmental goals
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures, where ability to recognize deviation from accepted practice is required.
- Leads and participates on cross-functional teams related to compliance projects and programs; ability to work independently as required.
- Bachelor s Degree or equivalent experience
- 5 - 7 years experience in GMP regulated industry
- Experience in supervision of quality assurance, quality control, and/or regulatory affairs
- Experience with assisting or managing QA audits and inspections as well as interfacing with clients and regulatory agencies.
- Thorough understanding of Good Manufacturing Practices, which includes Good Documentation Practices
- Good working knowledge of pertinent regulations and site SOPs
- Demonstrates strong leadership ability, communication, and facilitation skills
- Ability to analyze and interpret data
- Need to be able to read, write and understand English
- Proficient in computer programs (e.g., Microsoft Office, MasterControl, STARLIMS)
- Must be able to work in environment with variable noise levels
- Must be able to work in lab setting with exposure to biohazards / chemicals
- Ability to stand / sit / walk for long periods of time
- Must be able to wear appropriate PPE
- Must be able to perform activities with repetitive motions
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