Quality Systems Compliance Manager
The Quality Systems and Compliance Manager is responsible for providing oversight and management for assigned Quality Systems and Compliance activities within the Houston manufacturing site. This includes managing and facilitating Quality System implementation, standardization, and routine operations as well as serving as a Compliance/Regulatory resource to site Operations management and ensuring compliance with all applicable cGMPs, legal, ISO, and regulatory requirements.
Manage and facilitate Quality System implementation, standardization, and adherence for the nonconformance/CAPA, Change Control, and Document Control systems within the Houston manufacturing site. This may include specialized training on investigative techniques/writing, routine site reporting, leading various certification programs, system evaluation for efficiencies, archiving and destruction ac-tivities, etc.
Develop, implement, and ensure performance expectations are met for the local complaint process, management review and metric reporting, and the internal quality audit program. This includes alignment between site, corporate, and regulatory requirements and may involve multi-site calibration. Also includes active tracking of site Quality Plan activities.
Develop and deliver/participate in training programs for annual cGMP and audit readiness training. This includes new hire and routing training for cGMP and corporate requirements as well as assigned Quality and Compliance Systems (i.e. CAPA systems and Complaints). This may also include multi-site collaboration and sharing of experiences and best practices.
Coordinate, prepare, and manage site external audit activities and responses. Coordinate/perform routine and ad hoc Quality Systems metric reporting and analysis for both the local site and corporate levels.
Support both local and corporate requests for compliance and regulatory assessments. This may include coordination across global affiliates per request and nature of assessment.
Lead site activities related to post market action assessments and actions as needed. This includes cross functional coordination both within the local site and within the company network.
Provide leadership, direction, and support to Compliance/Quality personnel to ensure they are qualified, achieve a high level of competence, are motivated, and carry out duties in a safe manner.
Lead and/or support other duties as assigned. EEO Statement 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. Minimum requirements Minimum: BS in Eng or Physical Sciences (Chemistry, Physics) or education/experience in Medical Devices or Pharmaceuticals
Preferred: MS Engineering or Physical Sciences. CQM or CQA English
Minimum: Education/ Experience in Medical Devices or Pharmaceuticals
- Experience in managing others at various levels and coordinating cross-functional teams
- Experience in Quality Assurance, CAPA, Change Control. Document Control. Training Systems, Compliant Handling, and Compliance/Regulatory Affairs in Medical Device or Pharmacueticals, required
- Experience in interaction with FDA or other regulatory agencies.
- Strong knowledge of cGMPs and domestic regulatory requirements.
- Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, automation, validation, SPC, etc.)
- Experience with ISO Standards in Medical Devices and process improvements. Preferred: 7 years of directly related experience in regulated industry for Medical Device, Pharmaceuticals or equivalent, to include 5 years of leading people.
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