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Manager Of Quality & Compliance

Job Category: Pharmaceutical & Biotech

Job DescriptionPosition Purpose : Fulfill compliance activities within Novartis Consumer Health (NCH), Over-the-Counter (OTC) Drug Safety and Pharmacovigilance (DSP) US to meet Novartis internal requirements and legal obligations, with special emphasis on compliance, internal inspections, generation of quality and compliance reports and assistance in audits by governmental health authorities.

General Task Working with staff and Medical Safety Associates, ensures that up to date and version controlled training materials are prepared, available and catalogued.

Performs customer tailored SOP, ARGUS and MedDRA training in the US, interacting/assisting DSP affiliates and also other NCH OTC line units under the direction of the Head Global Drug Safety Compliance & Safety Intelligence .

This position will reside in the US-Parsippany NJ. Key Responsibilities: · Creation of corrective action/preventative action plan for compliance concerns (ie ADE reporting, inspections, training concerns) under the direction of the Global Head.

· Supervises, plans and conducts internal quality and compliance inspections of drug safety functions in NJ/Nyon/affiliates/line units as needed · Provides assistance during health authority audits and in preparation of any needed responses · Supervises and assists in preparation of QA and monthly DSP reports · Assists in preparation of training plans.

· Assists in creation of all relevant training documents and in training as necessary in conjunction with the department trainer.

· Provides assistance and guidance with training of all applicable company procedures (ie conventions, MAP, etc.) in NJ, Nyon and affiliates/line units · Provides compliance related metrics as assigned · Identifies process improvement needs and root cause analysis of quality and compliance issues · Attends all necessary meetings/activities (ie Audits, compliance related meetings, etc.) · Supervises and assists with internal, departmental audits (eg case processing, records room, ISEC related internal checks, etc.) · Supervises and assists in safety intelligence data gathering and analysis · Travel as needed · All work will meet quality requirements consistent with: Novartis standards Health authority standards Industry standards Minimum requirementsPosition Requirements & Education Qualifications and experience: · BA or BS required · Degree in pharmacy (RPh, PharmD), or nursing (RN, LPN) or life sciences (eg MD, DDS, DPod, PA).

· 4-5 years experience in Drug Safety · Good knowledge of local regulatory and additional health authority requirements in relation to Pharmacovigilance · Experience in inspections and auditing is highly desirable.

· Knowledge of GCP regulations, computer validation and part 11 requirements desirable.

· Prior and documented successful experience in Drug Safety training · Previous managerial experience · PC knowledge in MS Office, EXCEL and PowerPoint applications · High standard of written and spoken English.

Skills and knowledge: · Captivating and charismatic speaker · Excellent oral and written presentation skills · Computer applications · Interpersonal communications, · Negotiation/problem solving, · Capacity workload planning and prioritizing, · Report writing · Team work Behavior · High ethical and moral attributes · Open and honest · Ability to quickly adjust to changing priorities · Ability to work with minimum supervision Required years of experienceThree - Five Years

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