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Intellectual Property - Litigation - Life Sciences General Attorney in Waltham, MA

Fresenius Medical Care Holdings, Inc. Aug 22,2017 Aug 09,2017 Location USA Waltham MA
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In-House

Attorney

Intellectual Property - Litigation - Life Sciences General

Min 5 yrs required

Profile

Quality Systems Auditor The candidate must have seasoned, experienced professional with a full understanding of quality systems auditing, schedules, plans, conducts, and leads audits in accordance with the Corporate QS Audit Program. Will act as a subject matter expert. Ensures audit activities are in compliance with company procedures and regulatory requirements.. Disseminates audit findings to senior management as required by the Corporate QS Audit Program. Will provide extensive regulatory expertise as needed to support QS improvement initiatives. Will develop and creates audit reports, coordinates action plans, and follow up with auditee to assure prompt and adequate completion of agreed upon actions. Will establishes and conducts sectional readiness training for FMC RTG sites and QS functions. Serves as GMP subject matter expert (SME) for regulatory inspections, as needed. Creates, revises, develops, and reviews standard operating procedures used for GMP auditing. Will perform any other tasks as requested by Management to support quality oversight activities. Will help development and reporting of quality and compliance metrics related to Compliance audit activities. Leads contracted 3rd party audit activities used for supporting the Corporate QS Audit Program. Coaches/mentors staff as a means to ensure performance and professional development. Establishes/maintains effective cross-functional team communications to advance FMC quality activities. Will works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations. Will assist with various projects as assigned by a direct supervisor.

Qualification and Experience

The candidate must have minimum BA/BS Degree required, MS, MBA or JD preferred. Must have minimum 5 years of GMP auditing work experience in the medical device, pharmaceutical, or biotech industry. Experience in medical device or pharmaceutical R&D or manufacturing (experience outside of auditing) desired. With a Master’s Degree minimum 3 years of experience required. Must have Extensive knowledge of good manufacturing, strong understanding of FDA/ICH regulations and Quality Systems; Solid background in Quality Assurance/Systems. Outstanding auditing skills and attention to detail with audit program implementation including interpreting regulations, guidelines, and identification of compliance issues. Demonstrated broad expertise related to the principles and application of quality and regulatory compliance. Demonstrated ability to effectively communicate and influence the outcomes of the decision making process .Displays highly developed organizational leadership qualities and effective coaching abilities. Listening, interpreting, and summarizing information skills must be highly developed. Excellent communication and writing skills; Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships. Ability to work both independently with direction and within project teams to attain goals. Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint). Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.

Additional info

Job ID- 17000IVH

Company info