Quality Control Manager

**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 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**. **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 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. **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 cross-functional teams**. * Experience resolving technical issues in a **multidisciplinary environment**. **Education** * 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. * Microbiology experience in **quality control** within a **biotech**, **pharmaceutical**, or **biopharmaceutical manufacturing** environment is helpful. * Prior supervisory experience is preferred. **Competencies** * 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.  _The annual base pay for this position ranges from_ _$ 112,604.80 - 168,907.20._ _Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans._ **Date Posted** 04-Aug-2026 **Closing Date** 31-Aug-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.