Novartis Pharmaceuticals Compliance Manager in Houston, Texas
Job ID 198351BR
Posting Title Compliance Manager
Business Unit QUALITY ASSURANCE AL
Work Location Houston, TX
Company/Legal Entity Alcon Research, Ltd.
Functional Area Quality
Job Type Full Time
Employment Type Regular
Job Description Provide oversight and management for assigned Quality and Compliance functions within the Houston manufacturing site. Serves as a Compliance and Regulatory resource/consultant to site Operations management and ensure compliance with cGMPs, legal, ISO, regulatory requirements and Novartis Quality Manual requirements.
Timeliness and completeness of complaint investigations and CAPAs .Timeliness and completeness of assigned Quality System records including nonconformance and CAPA, Change Controls, periodic SOP reviews, training, etc. Effectiveness of CAPAs in reducing recurring nonconformance and site-controllable complaint rates. Timeliness and adherence to schedule of assigned training as trainer. Timeliness and correctness of Management Review and all metric reporting responsibilities Timeliness and correctness of compliance and regulatory assessments including Change Control, site and corporate risk assessments, post market action assessments, etc. Effective strategic and tactical management of external audits and timeliness and completeness of responses. Effective management of internal and external audit, risk assessment, and Quality Plan actions (on time and complete delivery from cross functions teams). Successful external audit results for assigned areas of oversight and management (no significant observations). Timeliness of assigned project plan deliverables.
Provide strategic and tactical support for the Compliance Team in driving systems and initiatives. Responsibilities include development and/or critical evaluation of systems and solutions. Manages multiple layers of supervision with department (direct reports, leads, supervisors, etc.)
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
BS in Engineering or Physical Sciences (i.e. Chemistry, Physics, etc.) or other appropriate education and experience in Medical Devices or Pharmaceuticals. English. Minimum of 7 years of Quality Management experience in Medical Devices/Pharmaceuticals. Experience in managing others at various levels and coordinating cross-functional teams. Experience in Quality Assurance, CAPA Systems, Complaint Handling, and Compliance or Regulatory Affairs in Medical Device or Pharmaceuticals is required. Experience in interaction with FDA or other regulatory agencies. Strong knowledge of cGMPs and domestic regulatory requirements. Knowledge of Change Control. documentation systems, SPC,. training systems, validation, and manufacturing processes. Experience with ISO Standards in Medical Devices and Process improvement.