Quality Control Manager

AstraZeneca•Bogart, GA

1d•$112,605 - $168,907•Onsite

About The Position

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 registrations. In 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.

Requirements

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 cross-functional teams.
Experience resolving technical issues in a multidisciplinary environment.
Candidates must have completed a Bachelor’s degree or have comparable experience in biological sciences, chemical sciences, business, or a similar technical field. Experience equivalent to a Bachelor’s degree or relevant experience in a regulated industry will also be considered.
Advanced understanding of the laboratory environment and laboratory techniques used in the analysis of biological drug products.
Strong organizational, collaboration, and communication skills.
Ability to communicate effectively with senior management and cross-functional collaborators.
Strong understanding of cGMP operations, testing concepts, and supporting quality systems.
Ability to work effectively across functions, levels, and teams.

Nice To Haves

Microbiology experience in quality control within a biotech, pharmaceutical, or biopharmaceutical manufacturing environment is helpful.
Prior supervisory experience is preferred.

Responsibilities

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 insourcing 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.