REGISTRIEREN

Jobbörse

Finde Jobs in deiner Nähe – ob vor Ort, hybrid oder remote.
  • Ähnliche Jobs zu: Associate Director Quality Assurance
XX
Associate Director Quality AssuranceBecton Dickinson • El Paso, Texas, United States
Jetzt Bewerben
XX

Associate Director Quality Assurance

Becton Dickinson
  • US
    El Paso, Texas, United States
  • US
    El Paso, Texas, United States
Jetzt Bewerben

Über

Job Overview Associate Director, Quality Assurance provides strategic leadership and oversight of the site Manufacturing Operations to ensure compliance with FDA regulations (21 CFR Parts 210, 211, and 820), EU GMP, and ISO 13485 standards. The role is accountable for quality oversight across the manufacturing process of formulation, filling, triton, and Cascade Water Sterilization process (CWS). It supports contamination control strategies, risk‑based decision‑making, and sustainable compliance culture while enabling operational excellence and supply continuity. Responsibilities Ensure adherence to cGMP requirements (21 CFR 210/211, 820), EU GMP, and ISO standards. Provide independent quality oversight of manufacturing operations, including in‑process controls, batch record review and approval, and timely disposition decisions based on risk assessment. Drive increased quality presence on the shop floor to ensure real‑time compliance and issue resolution. Align production and process controls with validated states and lifecycle requirements. Ensure investigations, CAPA, deviations, change control, and complaints are effectively implemented, sustainable, and inspection‑ready. Maintain proactive communication with R&D, Design, Regulatory Affairs, and Pharma stakeholders. Lead risk‑based decision‑making using quality risk management principles. Analyze trends across investigations, complaints, and process performance to identify systemic issues and drive improvements. Lead development and documentation of structured, data‑driven analyses to support root cause identification and continuous improvement. Serve as QA Subject Matter Expert during internal and external regulatory inspections, ensuring accurate representation of quality systems. Verify effectiveness of CAPAs through robust verification of effectiveness (VoE). Define and anticipate data requirements, including non‑standard datasets, and ensure collection of robust data to support evaluation of complex issues. Lead, coach, and develop a high‑performing QA organization, ensuring appropriate capability across operations and quality systems. Establish clear accountability, drive ownership, urgency, and execution discipline across the team. Develop succession plans and ensure organizational readiness to sustain compliance. Act as a key contributor to the quality site leadership team, aligning quality strategy with business objectives. Manage departmental budget, resources, and priorities to ensure effective deployment aligned with business needs and compliance risks. Qualifications Bachelor’s degree in Chemical Engineering or Science (Master’s preferred). Minimum 10+ years of experience in quality within pharmaceutical manufacturing. Minimum 5+ years in leadership roles with direct people management responsibility. Strong experience with FDA inspections and regulatory interactions (e.g., 483s, Warning Letters). Skills Experience interfacing with domestic and foreign government agencies. Experience with SAP preferred. Experience with Lean/Six Sigma preferred. Computer proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Outlook). Pharmaceutical experience is a must. Physical Demands Must be able to lift, push/pull, and carry up to 25 pounds. Must be able to wear appropriate personal protective equipment as required. Position requires sitting or standing for long hours. Use of hands and fingers to manipulate office and calibration equipment is required. Work Environment Manufacturing. Benefits & Work Details Primary Work Location: USA, TX – El Paso – Northwestern Dr. Work Shift: Flexible. To learn more about BD visit https://bd.com/careers . Equal Opportunity Employer Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
#J-18808-Ljbffr
  • El Paso, Texas, United States

Sprachkenntnisse

  • English
Hinweis für Nutzer

Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klick auf „Jetzt Bewerben”, um deine Bewerbung direkt auf deren Website einzureichen.