Quality Compliance Team Leader - Axelon Services Corporation

Positive Release of Finished Goods is at the core of this position s daily responsibility.

A key role is to maintain a comprehensive site documentation system, author and maintain the site Validation Master Plan, and ensure site-wide compliance to 21 CFR Parts 11, 210, 211, and 820.

Responsibilities Include:

• coaches and mentors site personnel in regard to Compliance issues.
• Lead/participate in consumer/customer satisfaction improvement initiatives.
• Support the development, implementation, and monitoring of the manufacturing site Quality Plan to ensure compliance with both GMP s and CP Global Quality Standards.
• Responsible for daily documentation authorizing product release and the execution of release procedure.
• Interpret and communicate regulatory policies and requirements to CP personnel (local resident expert and leader for compliance and related GMP concerns).
• Supervision and management of plant Documentation system (This includes all documents vital to an FDA inspection- SOP s, Management of Change, Notices of Deviation, Batch Records, Non conformances, and Validations)
• Supervise Consumer Complaint trends and history. Ensures that all returned samples and adverse event complaints are fully investigated and documented.
• Manage the Site Annual Product Review and provide necessary compliance documentation and corrective action strategies for continuous improvement
• Ensure that the designs, specifications, implementation, and maintenance of an cGMP system follows current regulations and CP standards
• Supervision and management of site s Management of Change (MOC) program.
• Supervision and management of FDA Drug Listings and international drug registrations.
• Contribute to the local Automation, Digitization and Analytics (ADA) strategy, in specific with the paperless initiatives.
• Ensures the development of people, teams, and organizational capabilities by empowering team members through training, information sharing, mentor, feedback, and delegation

Required Qualifications

• Bachelor s Degree (or equivalent university degree) in Chemistry, Microbiology, Biochemistry, Engineering, or a related field.
• 5+ years work experience in a manufacturing plant operating in a Food or Drug / GMP environment.
• Comprehensive knowledge of site wide documentation system, Product Release, and Batch record review.
• Must be familiar with and able to implement GMP compliant Failure Investigations, Corrective and Preventive Actions, and Notices of Deviation.
• Knowledge of Change Control Systems and FDA regulations.
• Leadership skills.
• First-hand experience managing or supporting regulatory inspections.
• Experience with SAP QM, LIMS, or similar integrated computerized systems.

Preferred Qualifications:

• Supervisory experience.
• Building and supporting strategic relationships and common programs with Product Development, Regulatory Affairs, Supply Chain Management, EOHS, and Global Materials, Logistics & Sourcing Departments, as well as material/component suppliers is also an expectation of this position.
• 2 years of experience preparing documentation for Product Registration in country of sale.
• 2 years of experience managing Consumer Complaints.
• 2 years of experience completing Product Release documentation and final approval.
• Experience in hosting/leading an FDA inspection is highly desired.
• Experience with utilization of statistical tools (e.g. MiniTab) is desired.