Quality Compliance Head
The Quality Compliance Head will develop and maintain systems related to compliance oversight of the APD facilities. The Quality Compliance Head will serve as technical and regulatory consultant to Operations Management and ensure compliance with cGMPs, legal and ISO regulatory requirements as well as Alcon and Novartis Quality Manual requirements. Appointed as Deputy Management Representative for Alcon Precision Device (APD). Develop strategies and direct compliance activities that ensure quality and safety standards are met for our product. Apply technical knowledge to provide QA oversight for manufacturing quality systems and validation. Develop/improve QA programs, policies, processes, procedures, and controls to ensure that product performance and quality conform to established standards and agency guidelines. Provide expertise and guidance to interpret government regulations, agency guidelines and internal policies to assure compliance to current requirements and expectations. Establish/ensure compliance with continual good manufacturing practice (cGMP). Oversee compliance activities of complex nature as per schedule and standards/SOPs, and provide guidance, knowledge and expertise to compliance team. Support compliance team as SME on topics such as: cGMPs, Complaint Investigation process, Non-conformance/CAPA, Gap Assessment, external standards and the Novartis Quality Manual. Exhibit sound judgment by evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach. Oversee and approve writing of SOPs relating to Compliance. Conduct peer review and approval of documentation produced by co-workers and provide feedback or coaching on how to improve. Direct and oversee compliance initiatives/projects or programs. Provide support for external audit inspections. Ensure that a Quality Management System (QMS) is established, documented implemented, maintained, reviewed and improved. Ensure that processes and resources needed for the APD Quality Management System are available. Responsible to understand, review and promote the awareness of customer, statutory, legal, and/or regulatory requirements throughout the organization. Properly evaluate the results of manufacturing control and quality control to decide whether to release and ship products from the manufacturing site. Verify that required internal quality system audits have been conducted appropriately. Ensure that documented reviews of the suitability and effectiveness of the Quality Management Systems are performed periodically by Top Management and that records of these QMS Management Reviews are maintained.
Preferred Experience in Quality Control, Quality Assurance, Documentation Control, Compliance and/or Regulatory Affairs in a Pharmaceutical, Medical Device or Healthcare Environment. Extensive knowledge of cGMP regulations for medical device manufacturing operations and validation procedures and practices.
In depth knowledge of external regulatory requirements (especially 21CFR210/211/820, EU GMP, USP, Ph EU, JPAL).
Regulatory Affairs certification or degree. M.S. Engineering or Physical Sciences (e.g. Chemistry, Physics, 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.
Bachelor's Degree or equivalent years of directly related experience. The ability to fluently read, write, understand and communicate in English 7 Years of Relevant Experience and 5 Years of Demonstrated Leadership
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