Associate Director, Quality Compliance-Alpharetta location

Company: Osmotica Pharmaceutical
Location: Alpharetta
Posted on: September 23, 2022

Job Description:

This position manages the site quality systems in Marietta (document control, logbooks, archival) as well as laboratory compliance, providing quality oversight for all laboratory activities to ensure quality and regulatory requirements (21 CFR 210, 211, and Part 11) are achieved. This position works through partnership with Analytical Services, Validation, ad system/process owners to ensure laboratory compliance requirements are defined and followed. This position is a backup for quality operations and validation compliance. DUTIES AND RESPONSIBILITIES Manage team of quality associates who perform activities related to quality systems and laboratory compliance. Maintain a document management system for the control and accessibility of GMP documents (e.g., protocols, specifications, and production records). Manage onsite and offsite storage solutions, ensuring timely and accurate retrieval mechanisms. Provide quality oversight for GMP laboratory activities Determine the acceptability of laboratory procedures and activities Approve or reject laboratory documents including SOPs, specifications, change controls, investigations, deviations, CAPA, protocols, reports, and other related documents Participate in improvement of laboratory processes to ensure quality and adherence to cGMPs Conduct, review, and/or approve 21 CFR Part 11 assessments on new and existing computerized systems and GMP software/vendors; review and disposition periodic re-qualification assessments Develop and manage quality metrics to provide a status of laboratory and quality system activities Provide laboratory compliance expertise in external laboratory issues (e.g., CMOs, contract labs) Manage quality agreements with site suppliers (e.g., raw materials, packaging components, contract labs) Maintain USP water system results and perform trending for site leadership Recommend opportunities for increased quality system efficiencies and operational improvement through modifications to current systems, implementation of new systems, and more efficient use of established system Approve or reject product stability protocols Approve or reject site work orders, calibration reports, and equipment qualification documents (as backup) Approve or reject site change controls, batch records, protocols, procedures, and policies (as backup) Support FDA and 3rd party inspections, and maintain site readiness for inspections Review industry trends, changes to regulations, and implement best practices whenever possible Perform other duties as assigned EXPERIENCE AND QUALIFICATIONS Bachelors of Science degree in related scientific discipline (e.g., chemistry, biochemistry, biology) 10+ years in QC laboratory and/or quality system role(s) in pharmaceutical or related industry 5+ years leadership or managerial experience in pharmaceutical or related industry Knowledge of laboratory compliance issues, regulatory requirements, quality systems, and best practices Proficient in MS Office suite Ability to manage multiple projects simultaneously while performing day-to-day activities Excellent ability to write, review, edit, and approve technical or scientific documentation Ability to present technical information to management, employees, and other departments Self-motivated team player with exceptional organization, follow-through, time management, and written and verbal communication skills Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management in the company Preferred Experience Previous experience managing a GMP laboratory Experience with computerized management systems (e.g. ERP, LIMS, CDS, QMS, etc.) This position is working out of the Alpharetta office. Job Type: Full-timePay: From $1.00 per yearBenefits: 401(k) matching Dental insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insuranceSchedule: 8 hour shiftAbility to commute/relocate: Alpharetta, GA 30005: Reliably commute or planning to relocate before starting work (Required)Education: Bachelor's (Required)Experience: QC laboratory and/or quality system role: 10 years (Required) leadership or managerial: 5 years (Required) cGMP: 5 years (Required)Work Location: One location

Keywords: Osmotica Pharmaceutical, Alpharetta , Associate Director, Quality Compliance-Alpharetta location, Executive , Alpharetta, Georgia