Quality Control CTL Manager at Adverum Biotechnologies ensuring efficient QC testing across contract labs. Collaborating with teams and managing method validation in a hybrid role.
Responsibilities
Manage all QC Release and Stability sample testing activities at all CTLs, including but not limited to, sample and reagent shipment coordination, shipment temptale review, updated test method review/approval, advise on lab scheduling and test priority, support problem solving activities at CTLs for test directives, support OOS/OOE/OOT/Atypical lab investigations, final test data COA review/acceptance.
Manager/support method transfer and method validation activities at CTLs and CMOs, including but not limited to, protocol review/approval, reagent shipment coordination, method validation design and document review/approval, validation data packet evaluation, final report review/approval.
Author and revise internal SOPs, forms, and documentation related to CTL management, data review, and lab investigation activities.
Support CTL and CMO lab audit activities if needed.
Participate in internal audits, external inspections, and quality system assessments by providing documentation and subject‑matter expertise.
Collaborate cross‑functionally with QC, QA, Manufacturing, Supply Chain, and Facilities to improve processes, reduce risks, and strengthen compliance.
Contribute to continuous improvement initiatives to streamline laboratory workflows and enhance data integrity.
Requirements
Bachelor’s degree in a scientific discipline (Biology, Chemistry, Biochemistry, or related field).
Minimum 4–6 years of work experience in a GMP analytical laboratory and/or QC environment.
Prior CTL management experience is preferred
Strong understanding of cGMP requirements and regulatory expectations for biotechnology and pharmaceutical QC operations.
Experience with LIMS, electronic inventory systems, or sample tracking databases.
Familiarity with stability programs and chain‑of‑custody workflows.
Strong organizational skills with exceptional attention to detail and documentation accuracy.
Excellent communication skills and ability to work cross‑functionally.
Demonstrated problem‑solving ability and adaptability to shifting priorities.
Proficiency with MS Office and laboratory equipment software.
Governance & Risk Lead at Chain IQ responsible for S2C and P2P service delivery excellence. Collaborating closely with internal teams to manage risks and ensure quality compliance.
Technical Bid Manager leading technical and commercial offers for ABB, a global technology company. Responsible for developing competitive service offers throughout the sales phase.
Plant Sr Manager responsible for operations from procurement to shipment at packaging manufacturer. Leading compliance and safety initiatives while ensuring quality and productivity standards are met.
EHS Regional Manager driving and supporting EHS programs and compliance at Hubbell Incorporated. Ensuring safety initiatives and continuous improvement in environmental health and safety operations.
Clinical Manager overseeing hospice services at Affinity Hospice. Responsible for coordination and management of patient care with an interdisciplinary team.
Manager overseeing medical review processes for Medicare claims at BlueCross BlueShield of South Carolina. Ensuring compliance with standards and laws while driving continuous improvement in claim processing.
Restaurant Leader Trainee responsible for managing restaurant operations and leading team at 7 - Eleven. Focusing on customer service, training, and business compliance in a fast - paced environment.
Quality Systems Manager overseeing quality systems, compliance and food safety initiatives at McCormick's plant. Managing HACCP and quality assurance programs in a food manufacturing environment.
Quality Systems Manager overseeing the development and implementation of Quality Systems at McCormick. Ensuring compliance with regulations and managing sanitation and HACCP requirements in food manufacturing.
Manager overseeing medical claim reviews ensuring compliance with standards and implementing process improvements. Engaging with regulatory bodies and maintaining quality performance standards in healthcare.