Senior Manager QA Head, Medical Device

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. Job Summary Responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications. Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR/98-282), EU Medical Device Regulation 2017/745. Ensure site readiness for regulatory agency inspections and/or Sun Corporate Audits. Area Of Responsibility Responsible as “Management Representative”, leading all regulatory inspections related to medical device and combination products (FDA/ISO). Lead Management Review meeting ensuring the Quality Management Systems (QMS) is suitable and effective. Review and approve Device History Records related to medical device products. Oversite and continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations. Work directly on technical investigations relating to medical device Quality Complaints. Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries. Provide oversight of the vendor/supplier management Program and work closely on device issues and develop quality vendor/supplier agreements with all key vendor/supplier. Participate in all vendor/ supplier change notification review and approvals. Ensure Annual supplier/vendor assessment, maintenance of supplier/vendor audit schedule, status tracking and approved supplier list (ASL). Review and approve all medical device related documents as authorized and describe by procedures. Manage electronic Quality Management System (Track Wise) Author/revise standard operating procedures (SOPs) related to medical device and associated systems aligning with regulatory guideline and corporate policy as required Other duties as assigned Work Conditions Office Manufacturing Floor Warehouse Third Party site (as required) Education And Job Qualifications Bachelor’s degree in Science or related scientific fields Strong knowledge of medical devise regulations including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282). Demonstrated ability to lead QA medical device and combination products compliance and auditing operations, make sound decisions regarding evaluation of cGMP compliance, and leadership ability. Demonstrated understanding and deployment of modern root cause and problem solving techniques such as statistical process controls and quality function deployment. Excellent understanding of medical device QA principles, industry practices, and standards Demonstrated ability of multi-task and manage completing priorities. Demonstrated strong ability in problem solving Superior internal and external customer service/people skills Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner. Ability to work both independently and collaboratively in team structure. Excellent verbal and written communication skills, including ability to influence others. Excellent organizational and time management skills with a high level of attention to detail. Minimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment. Strong knowledge of medical devise regulations including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282). Experience in leading and/or supporting medical device regulatory inspections by FDA and Health Canada, corporate audits and third party audits. Strong knowledge of review and approve device history records related to medical devices. Strong knowledge of handling of medical device related complaints. Knowledge of vendor/supplier management Program Working knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data, EDMS for SOPs and LMS for trainings. Strong working knowledge of MS Office software. Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc… Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

#J-18808-Ljbffr