Quality Control Manager Bogart United States of America QAQM - Quality Management Pos

Position: Quality Control Manager Bogart  United States of America QAQM - Quality Management Pos[...]
## Quality Control Manager Bogart, Georgia, United States of America Apply Now Find out how well you match with this job
** Position Summary
** The person in charge of QC is responsible for leading all Quality Control activities at the Alexion Georgia Manufacturing Facility in Bogart, including oversight of QC operations, personnel, and budget. The role includes responsibility for
** microbiological and analytical testing
** of commercial egg white and related materials,
** genetic testing
** for
** Kanuma LAL-C chickens**, and
** facility and utility monitoring**, including management of testing performed by contract laboratories where applicable.

This leader will define and complete the site’s
** QC strategic roadmap
** to strengthen
** business continuity**,
** risk mitigation**,
** continuous improvement**,
** compliance**, and
** microbial control**.The role is also accountable for ensuring
** compliance
* * and
** inspection readiness
** across all on-site QC activities in accordance with regulatory and quality requirements, including testing to licensed specifications, oversight of contract testing services, and technical support for new  addition, the QC Manager will support development and execution of the
** Global Lab Systems Strategy**, including
** annual goals and objectives**,
** long-range planning**,
** budget planning**,
** people strategy**, and
** laboratory performance management**.
** Principal Responsibilities
**** The successful candidate will:**
* ** Lead QC operations
** to ensure laboratory activities are compliant, efficient, and safe, while applying testing,
** Lean**, and
** safety standards**.
* ** Handle QC laboratory teams
** supporting in-process testing, microbiological site support, and
** CLO testing activities**.
* ** Oversee laboratory scheduling and performance
** to meet regulatory, quality, and business requirements.
* ** Ensure validation and qualification
** of test methods and instruments supporting in-process and commercial release testing.
* ** Maintain inspection readiness
** and represent QC during audits, inspections, and regulatory interactions.
* ** Lead QC risk assessments
** and ensure timely implementation of mitigation actions.
* ** Direct the environmental monitoring program
** in partnership with Manufacturing to maintain a robust processing and monitoring strategy.
* ** Drive analytical method transfers and CLO in sourcing
** to support the QC transgenic roadmap and improve business continuity and risk mitigation.
* ** Lead recruitment, retention, development, and performance management
** of QC staff to build an agile and flexible organization.
* ** Oversee the QC training strategy**, including development, delivery, evaluation, and retraining programs as needed.
* Ensure effective quality control assistance for investigations, including laboratory investigation reports, deviations, and CAPAs, in compliance with Alexion procedures and timelines. Including the completion of LIR and EM trend reports.
* ** Lead tiered communication and task prioritization
** within QC to support commercial operations.
* ** Ensure timely completion of testing and data review/approval
** to support batch disposition.
* ** Provide QC support
** for the
** APQR process
** and
** process monitoring activities**.
* ** Build continuous improvement capability
** within QC and apply CI tools to drive performance improvements, with focus on new technologies and appropriate use of AI.
** Qualifications**
* ** Minimum 10 years
** of experience in a
** GMP laboratory**.
* Demonstrated ability to
** build, mentor, and develop high-performing teams**.
* Shown success working in a
** matrix organization**.
* Comprehensive knowledge of current regulatory requirements related to stability, raw materials, and QC operations in regulated environments.
* Demonstrated
** people leadership
** and experience handling cross-functional teams.
* Consistent record of implementing
** Lean laboratory practices**, including
** 5S**,
** visual management**, and paperless lab approaches.
* Strong
** project management
** capability.
* ** Auditing experience**.
* Experience representing a functional area on
** network or…